The Global Market for Point of Care Diagnostics - … · The Global Market for Point of Care Diagnostics: ... CK-MB Cardiac Marker Test ... The Global Market for Point of Care Diagnostics:

The Global Market for Point of Care Diagnostics:Major Players and Key Issues

VOLUME 1

COMPANY ANALYSES

©Espicom Business Intelligence June 2006ii

The Global Market for Point of Care Diagnostics: Major Players and Key Issues

June 2006

ISBN: 1 85822 261 3

© Copyright 2006 Espicom Business Intelligence Publications Limited

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©Espicom Business Intelligence iiiJune 2006

Point of Care Diagnostics Table of Contents

CONTENTSOverview.......................................................................................................................................................1

POCT Relative to the Global In Vitro Diagnostics Market, 2005 ............................................................................................................................................................. 1Point of Care Diagnostics .................................................................................................................................................................. 3Global POCT Market by Region, 2005 (Global Market = US$10.6 billion) ............................................................................................................................................. 3European* POCT Market by Region, 2005 (Market = US$3.0 billion) ................................................................................................................................................... 3

POC.MANUFACTUrerS...................................................................................................................................5Abaxis......................................................................................................................................................................................5

Clinical Chemistry Analyser .............................................................................................................................................................. 6Piccolo........................................................................................................................................................................................................................................... 6

Agreements ......................................................................................................................................................................................... 6bioMérieux SA ............................................................................................................................................................................................................................. 6PSS World Medical ....................................................................................................................................................................................................................... 6Chatani ......................................................................................................................................................................................................................................... 7

Abbott.Diagnostics................................................................................................................................................................8i-STAT 1 ................................................................................................................................................................................................. 8

Cartridges for use with i-STAT ..................................................................................................................................................................................................... 8i-STAT CHEM 8+ cartridge .......................................................................................................................................................................................................... 9CK-MB Cardiac Marker Test .......................................................................................................................................................................................................... 9i-STAT BNP ................................................................................................................................................................................................................................... 9

Agreements ......................................................................................................................................................................................... 9Axis-Shield .................................................................................................................................................................................................................................... 9OraSure ...................................................................................................................................................................................................................................... 10

Accumetrics...........................................................................................................................................................................10Platelet Function Analysers ............................................................................................................................................................ 10

VerifyNow Rapid Platelet Function Test.................................................................................................................................................................................... 10VerifyNow P2Y12.........................................................................................................................................................................................................................11VerifyNow IIb/IIIa Assay ............................................................................................................................................................................................................ 12

ACON.Laboratories...............................................................................................................................................................12Glucose Monitoring ......................................................................................................................................................................... 12

On Call Now Blood Glucose Monitoring System ...................................................................................................................................................................... 12On Call Blood Glucose Visual Strips ........................................................................................................................................................................................... 13

Drugs-of-abuse tests ....................................................................................................................................................................... 13CLIA waived status for E-Z Split Key Cup and multi-line drugs of abuse device tests ........................................................................................................................... 13Oral Fluid Multi-Drug One Step Multi-Line Screen Test Device ............................................................................................................................................................ 14Home Drug Test .................................................................................................................................................................................................................................... 14COT Cotinine One Step Test Device ........................................................................................................................................................................................................ 14Saliva Alcohol Test Strips (DAL-701) ...................................................................................................................................................................................................... 14

Infectious Disease Tests ............................................................................................................................................................................................................. 14Infectious Mononucleosis Rapid Tests .................................................................................................................................................................................................. 15Strep A Twist Rapid Test Device ............................................................................................................................................................................................................ 15

HIV Test ....................................................................................................................................................................................................................................... 15Pregnancy hCG Tests .................................................................................................................................................................................................................. 15Cardiac Marker Tests .................................................................................................................................................................................................................. 16

One Step Myoglobin/CK-MB/Troponin I Combo Rapid Test Device (CMA-435) ................................................................................................................................... 16Myoglobin One Step Test Device (CMY-402) ........................................................................................................................................................................................ 16CK-MB One Step Test Device (CCK-402) ................................................................................................................................................................................................ 16

Tumour Marker Tests ................................................................................................................................................................................................................. 16AFP Rapid Test Device (Whole Blood/Serum/Plasma) ......................................................................................................................................................................... 17

Urinalysis .....................................................................................................................................................................................................................................17On-Call Urine Adulteration Test Strips (DUC-111) ................................................................................................................................................................................. 17

U120 Urine Analyser ...................................................................................................................................................................................................................17

©Espicom Business Intelligence June 2006iv

Point of Care DiagnosticsTable of Contents

Acquisition by Inverness Medical Innovations ........................................................................................................................... 17Aerscher.Diagnostics...........................................................................................................................................................19Alfa.Scientific.Designs..........................................................................................................................................................20

Instant-View Drug Screen Tests ..................................................................................................................................................20Analytes performed on this device: ..................................................................................................................................................................................................... 20CPT Code: ............................................................................................................................................................................................................................................. 20

Splitscreen .................................................................................................................................................................................................................................. 21Instant-View Fertility Tests........................................................................................................................................................................................................ 21

CPT Code: ............................................................................................................................................................................................................................................. 21Instant-View Faecal Occult Blood Test ..................................................................................................................................................................................... 21

Analytes performed on this device: ..................................................................................................................................................................................................... 21Advantages: ........................................................................................................................................................................................................................................ 21

Instant View Cardiac Marker Tests ............................................................................................................................................................................................ 22Troponin I (TnI) Whole Blood/Serum One Step Rapid Test ................................................................................................................................................................... 22

Instant-View Tumour Marker Test ............................................................................................................................................................................................. 22PSA (Prostate Specific Antigen) Serum Test .......................................................................................................................................................................................... 22Agreements .......................................................................................................................................................................................22

MedSurge Medical .................................................................................................................................................................................................................... 22Arkray....................................................................................................................................................................................23

HbA1c Analysers ...............................................................................................................................................................................23HA-8170 ...................................................................................................................................................................................................................................... 23HA-8160 ..................................................................................................................................................................................................................................... 23

POC Clinical Chemistry ....................................................................................................................................................................23SpotChem EZ .............................................................................................................................................................................................................................. 23

Electrolyte Analyser .........................................................................................................................................................................24SpotChem EL ...............................................................................................................................................................................................................................24

Blood Ammonia Meter ....................................................................................................................................................................24PocketChem BA ...........................................................................................................................................................................................................................24

Urinalysis ............................................................................................................................................................................................25PocketChem UA ......................................................................................................................................................................................................................... 25Aution Eleven ............................................................................................................................................................................................................................. 25Aution Micro ............................................................................................................................................................................................................................... 25

Aution Sticks – Urine Test Strips ........................................................................................................................................................................................................... 25Audit.Diagnostics.................................................................................................................................................................26

Cardiac (Triple Test) ..........................................................................................................................................................................26Tumour Marker/Cardiac Marker Point of Care Analyser ...........................................................................................................26

Dry Lab ....................................................................................................................................................................................................................................... 26Wet Chemistry POC analyser .........................................................................................................................................................26

Liqui-Stat ................................................................................................................................................................................................................................... 26Axis.Shield.............................................................................................................................................................................27

Instruments .......................................................................................................................................................................................27Afinion AS100 Analyser ............................................................................................................................................................................................................. 27NycoCard Reader II .................................................................................................................................................................................................................... 27Thrombotrack Coagulometers .................................................................................................................................................................................................. 28

Diabetes Tests ...................................................................................................................................................................................28Afinion HbA1c Test ..................................................................................................................................................................................................................... 28NycoCard HbA1c ........................................................................................................................................................................................................................ 28NycoCard U-Albumin Test .......................................................................................................................................................................................................... 28

Inflammation Tests ..........................................................................................................................................................................28Afinion CRP Test ......................................................................................................................................................................................................................... 28NycoCard CRP test ...................................................................................................................................................................................................................... 28

Coagulation Tests .............................................................................................................................................................................29

©Espicom Business Intelligence vJune 2006


Cephotest (APTT) .......................................................................................................................................................................................................................29Thrombotest (PT-INR) ................................................................................................................................................................................................................29Nycotest PT (INR)........................................................................................................................................................................................................................29NycoCard D-Dimer Test ..............................................................................................................................................................................................................29

Afinion Pipeline Short-Term ...........................................................................................................................................................30Point-of-Care Sales...........................................................................................................................................................................30Agreements .......................................................................................................................................................................................31

ITI Techmedia (Biosensor Platform for Theranostic Applications) ...........................................................................................................................................31Bayer.HealthCare................................................................................................................................................................. 32

Blood Gas ...........................................................................................................................................................................................32Rapidlab 800 ..............................................................................................................................................................................................................................32

Measured Parameters .........................................................................................................................................................................................................................33Sample Volumes ..................................................................................................................................................................................................................................33

Rapidlab 248 and 348 ................................................................................................................................................................................................................34Rapidlab 1200 ............................................................................................................................................................................................................................35

Parameters ..........................................................................................................................................................................................................................................35Sample Volume ...................................................................................................................................................................................................................................36

Rapidpoint 400 Series ................................................................................................................................................................................................................36Rapidlink Critical Care Information Management System .......................................................................................................37

RapidComm ...............................................................................................................................................................................................................................37Urinalysis - Point of Care .................................................................................................................................................................37

Clinitek Status Analyser .............................................................................................................................................................................................................37Clinitek 50 Urine Chemistry Analyser .......................................................................................................................................................................................38Clinitek 500 Urine Chemistry Analyser ......................................................................................................................................................................................38Multistix10 SG Reagent Strips ...................................................................................................................................................................................................38Multistix Pro ...............................................................................................................................................................................................................................39Clinitek Microalbumin Strips .....................................................................................................................................................................................................39

Diabetes & Glycated Haemoglobin ..............................................................................................................................................39DCA 2000+ Analyser .................................................................................................................................................................................................................39

Agreements .......................................................................................................................................................................................39Inverness Medical Innovations ..................................................................................................................................................................................................39

Supply Agreements .........................................................................................................................................................................40Premier .......................................................................................................................................................................................................................................40Novation .....................................................................................................................................................................................................................................40

BD.Diagnostics......................................................................................................................................................................41Flu Tests ..............................................................................................................................................................................................41

Directigen Flu A + B Test ..........................................................................................................................................................................................................41Directigen Flu A Test .............................................................................................................................................................................................................41

Respiratory Syncytial Virus Tests ..................................................................................................................................................41Directigen EZ RSV Test ..........................................................................................................................................................................................................41Directigen Respiratory Syncytial Virus (RSV) Test ...............................................................................................................................................................42

Meningitis Tests ................................................................................................................................................................................42Strep A Tests ......................................................................................................................................................................................42

BD Directigen EZ Strep A Test ....................................................................................................................................................................................................42BD Chek Strep A Test .............................................................................................................................................................................................................42LINK2 Strep A Rapid Test Kit .....................................................................................................................................................................................................42

H. pylori ..............................................................................................................................................................................................42LINK2 H. pylori Rapid Test ......................................................................................................................................................................................................42

C.difficile ............................................................................................................................................................................................43ColorPacToxin A Test ..................................................................................................................................................................................................................43BD ColorPac Giardia/Cryptosporidium test .................................................................................................................................................................43

Beckman.Coulter................................................................................................................................................................. 43

©Espicom Business Intelligence June 2006vi


FOB Tests ........................................................................................................................................................................................... 44Hemoccult ICT ........................................................................................................................................................................................................................... 44Hemoccult II SENSA elite ........................................................................................................................................................................................................... 44Hemoccult SENSA ...................................................................................................................................................................................................................... 44Hemoccult II .............................................................................................................................................................................................................................. 44Gastroccult ................................................................................................................................................................................................................................ 44ICON microALB ...........................................................................................................................................................................................................................45

Pregnancy Tests ............................................................................................................................................................................... 45ICON 25 hCG ................................................................................................................................................................................................................................45ICON II hCG ..................................................................................................................................................................................................................................45

Infectious Disease Tests ................................................................................................................................................................ 45ICON SC Strep A...........................................................................................................................................................................................................................45ICON DS Strep A ..........................................................................................................................................................................................................................45FlexSure HP ............................................................................................................................................................................................................................... 46

Acquisitions ...................................................................................................................................................................................... 46Diagnostic Systems Laboratories ............................................................................................................................................................................................. 46

bioLytical.Laboratories.......................................................................................................................................................46PMA Application for INSTI kit ........................................................................................................................................................ 46Comparison of HIV-Test Products ....................................................................................................................................................................................................... 47

Biomerica.............................................................................................................................................................................48FOB Test ............................................................................................................................................................................................. 48

EZ Detect ................................................................................................................................................................................................................................... 48H. pylori Test .................................................................................................................................................................................... 48

EZ-HP ........................................................................................................................................................................................................................................ 48Pregnancy Tests .............................................................................................................................................................................. 49

Fortel (5-Day OTC) .....................................................................................................................................................................................................................49Fortel Midstream .......................................................................................................................................................................................................................49

Prostate Cancer Test ....................................................................................................................................................................... 49EZ-PSA ........................................................................................................................................................................................................................................49

BioMérieux........................................................................................................................................................................... 49Emergency Diagnostics ................................................................................................................................................................. 50

VIDAS D-Dimer Exclusion ......................................................................................................................................................................................................... 50VIDAS Emergency Panel ........................................................................................................................................................................................................... 50

Agreements ...................................................................................................................................................................................... 50Abaxis ........................................................................................................................................................................................................................................ 50Roche Diagnostics ..................................................................................................................................................................................................................... 50Brahms .......................................................................................................................................................................................................................................51

Bio-rad.Laboratories.......................................................................................................................................................... 51Diabetes Monitoring - HbA1c Testing .......................................................................................................................................... 52

Micromat II HbA1c Instrument ................................................................................................................................................................................................. 52D-10 Haemoglobin Testing System ......................................................................................................................................................................................... 52

D-10 Rack Loader ................................................................................................................................................................................................................................ 52Drugs-of-abuse testing .................................................................................................................................................................. 53

TOX/See ..................................................................................................................................................................................................................................... 53HIV Tests ............................................................................................................................................................................................ 53

Multispot HIV-1/HIV-2 Rapid Test ............................................................................................................................................................................................. 53Supply Agreement .......................................................................................................................................................................... 53

Premier ...................................................................................................................................................................................................................................... 53BioSafe.................................................................................................................................................................................. 54

Self-Testing Kits ............................................................................................................................................................................... 54HbA1c Test ................................................................................................................................................................................................................................. 54THS Test ..................................................................................................................................................................................................................................... 54

©Espicom Business Intelligence viiJune 2006


PSA Test ...................................................................................................................................................................................................................................... 54Cholesterol Panel ....................................................................................................................................................................................................................... 54Anaemia Meter .......................................................................................................................................................................................................................... 55

Biosite....................................................................................................................................................................................55Stroke Test .........................................................................................................................................................................................55

Triage Stroke Panel .................................................................................................................................................................................................................... 55Cardiovascular Tests ........................................................................................................................................................................56

Triage BNP Test ........................................................................................................................................................................................................................... 56Triage Cardio ProfilER ................................................................................................................................................................................................................. 56Triage D-Dimer test .................................................................................................................................................................................................................... 56Triage Profiler Shortness of Breath Panel ................................................................................................................................................................................. 57Triage Cardiac Panel ................................................................................................................................................................................................................... 57

Drug Screening .................................................................................................................................................................................57Triage TOX Drug Screen .............................................................................................................................................................................................................. 57

Parasitic Disease Test .......................................................................................................................................................................57Triage Parasite Panel .................................................................................................................................................................................................................. 57

Agreements .......................................................................................................................................................................................57Oxford Genome Sciences ........................................................................................................................................................................................................... 57Eli Lilly ........................................................................................................................................................................................................................................ 58Fisher HealthCare ....................................................................................................................................................................................................................... 58Henry Schein .............................................................................................................................................................................................................................. 59Cleveland Clinic .......................................................................................................................................................................................................................... 59

Litigation ............................................................................................................................................................................................59Roche Diagnostics ...................................................................................................................................................................................................................... 59

Branan.Medical.....................................................................................................................................................................59Drugs-of-abuse testing ...................................................................................................................................................................60

Oratect II Oral Fluid Drug Screen Device ................................................................................................................................................................................... 60Urine product line ..................................................................................................................................................................................................................... 60

Intect7 Urine Adulterant Test Strips......................................................................................................................................................................................................60ToxCup Drug Screen Cup ......................................................................................................................................................................................................................60Monitect ...............................................................................................................................................................................................................................................60QuickTox ............................................................................................................................................................................................................................................... 61

Fastect II ..................................................................................................................................................................................................................................... 61CAre.Products......................................................................................................................................................................61

Professional Tests ............................................................................................................................................................................. 61ImmoCARE FOB Test .................................................................................................................................................................................................................. 61hemoCARE FOB Test ................................................................................................................................................................................................................... 62CARE FSH Fertility Test ............................................................................................................................................................................................................... 62

Home Use ...........................................................................................................................................................................................62ColonCARE FOB Test ................................................................................................................................................................................................................... 62CARE Menopause ....................................................................................................................................................................................................................... 63CARE Cholesterol Plus ................................................................................................................................................................................................................ 63CARE Cholesterol ........................................................................................................................................................................................................................ 63CARE Triglyx................................................................................................................................................................................................................................ 63

Chembio.Diagnostics...........................................................................................................................................................63HIV .......................................................................................................................................................................................................64

SURE CHECK HIV ......................................................................................................................................................................................................................... 64Tuberculosis Rapid Tests .................................................................................................................................................................64New Dual Path Platform (DPP) Technology for Rapid Diagnostic Tests ................................................................................65Other Products in Development ...................................................................................................................................................652005 Revenue and Highlights........................................................................................................................................................65

2005 Highlights: ......................................................................................................................................................................................................................... 66

©Espicom Business Intelligence June 2006viii


2006 and beyond .......................................................................................................................................................................................................................66Agreements .......................................................................................................................................................................................66

Cholestech.Corporation...................................................................................................................................................... 67Cholestech GDX System ................................................................................................................................................................67Cholestech LDX System ...................................................................................................................................................................67

Hs-CRP Test (not CLIA waived) ..................................................................................................................................................................................................67Agreements .......................................................................................................................................................................................68

AstraZeneca ...............................................................................................................................................................................................................................68Boule Diagnostic International ..................................................................................................................................................................................................68Itamar Medical ...........................................................................................................................................................................................................................69

Church.&.Dwight.................................................................................................................................................................. 70First Response Early Result Pregnancy Test ................................................................................................................................70First Response Easy-Read Ovulation Predictor Test .................................................................................................................70Answer Pregnancy and Ovulation Tests ......................................................................................................................................70Agreements .......................................................................................................................................................................................70

Quidel .........................................................................................................................................................................................................................................70Clinical.Data.inc................................................................................................................................................................... 71

Microlab 300 ..............................................................................................................................................................................................................................71Selectra Junior ............................................................................................................................................................................................................................71

Coagulation Analyser ......................................................................................................................................................................72Vitalab Fibron 1 .........................................................................................................................................................................................................................72

Dade.Behring....................................................................................................................................................................... 72Cardiac Analyser ...............................................................................................................................................................................73

Stratus CS ...................................................................................................................................................................................................................................73Viva-Jr Drug Testing System ..........................................................................................................................................................73Agreements .......................................................................................................................................................................................73

Cleveland Clinic ..........................................................................................................................................................................................................................73Diagnostic.Products.Corporation.......................................................................................................................................74

IMMULITE ...........................................................................................................................................................................................74IMMULITE 1000 .................................................................................................................................................................................75IMMULITE 2000 .................................................................................................................................................................................75IMMULITE 2500 ................................................................................................................................................................................75

Diagnostic.Test.Group.(rAC.Medical).................................................................................................................................75FOB Testing ........................................................................................................................................................................................76

Clarity Faecal Occult Test ............................................................................................................................................................................................................76Urinalysis ............................................................................................................................................................................................76

Urocheck 10 SG ...........................................................................................................................................................................................................................76UroCheck 2 GP and UroCheck 4 OB ...........................................................................................................................................................................................76

Strep A ................................................................................................................................................................................................76Clarity Strep A ............................................................................................................................................................................................................................76

Pregnancy ..........................................................................................................................................................................................77Clarity HCG Strips and Cassettes ................................................................................................................................................................................................77

eUMeD.Biotechnology........................................................................................................................................................ 77EUsure Blood Glucose Monitoring System ..................................................................................................................................77EUkare Blood Glucose Monitoring System..................................................................................................................................77In Development ................................................................................................................................................................................78

cHPV Detection System .............................................................................................................................................................................................................78Fisher.Healthcare................................................................................................................................................................ 78

Own brand diagnostic products ...................................................................................................................................................78Pregnancy Tests .........................................................................................................................................................................................................................78

Fisher Sure-Vue II Serum/Urine hCG Lateral Flow Test Kits ..................................................................................................................................................................78Coagulation Analyser .................................................................................................................................................................................................................79

©Espicom Business Intelligence ixJune 2006


Fisher Diagnostics Di-STAT D-Dimer System ........................................................................................................................................................................................ 79Infectious Disease Tests ............................................................................................................................................................................................................. 79

Mononucleosis Test .............................................................................................................................................................................................................................. 79Streptococcus Testing ................................................................................................................................................................................................................ 80

Fisher Sure-Vue Signature Strep A Test Kit ...........................................................................................................................................................................................80FlexSite.Laboratories...........................................................................................................................................................80

HbA1c Test..........................................................................................................................................................................................80Always 1n Control (A1C) ............................................................................................................................................................................................................. 80

Microalbumin Test ...........................................................................................................................................................................80Kidney Screen At Home ............................................................................................................................................................................................................. 80

Fujirebio.Diagnostics,.inc.....................................................................................................................................................81Tumour Assays .................................................................................................................................................................................81

CA 125 II radioimmunoassay - tumour marker for ovarian cancer .......................................................................................................................................... 81

CA 15-3 - tumour marker for early detection of breast cancer recurrence: ............................................................................................................................ 81CA 19-9 - tumour marker for pancreatic cancer ....................................................................................................................................................................... 81Other tumour markers ............................................................................................................................................................................................................... 81

Infectious Disease Products ..........................................................................................................................................................82Syphilis Test ................................................................................................................................................................................................................................ 82

Serodia-TP•PA ......................................................................................................................................................................................................................................82Thyroid Disease Test ................................................................................................................................................................................................................... 82

Serodia-AMC and Serodia-ATG ............................................................................................................................................................................................................82Serodia

MYCO II .......................................................................................................................................................................................................................... 82

ACE Color .................................................................................................................................................................................................................................... 82Genzyme.Diagnostics...........................................................................................................................................................83

Point of Care Tests ............................................................................................................................................................................83Pregnancy .................................................................................................................................................................................................................................. 83

OSOM Card Pregnancy ......................................................................................................................................................................................................................... 83OSOM hCG Combo test .......................................................................................................................................................................................................................... 83OSOM hCG Urine ...................................................................................................................................................................................................................................84

Infectious Diseases ..................................................................................................................................................................................................................... 84OSOM Ultra Strep A...............................................................................................................................................................................................................................84OSOM Strep A .......................................................................................................................................................................................................................................84OSOM Mono ......................................................................................................................................................................................................................................... 85OSOM Trichomonas Rapid Test ............................................................................................................................................................................................................ 85OSOM BVBLUE Test ............................................................................................................................................................................................................................... 85Development Projects.....................................................................................................................................................................85

Acute Myocardial Infarction ..................................................................................................................................................................................................... 85Cerebrovascular Disease ........................................................................................................................................................................................................... 86

Gi.Supply.(A.division.of.Chek-Med.Systems)......................................................................................................................86H. pylori Test ......................................................................................................................................................................................87

Hpfast ......................................................................................................................................................................................................................................... 87Giant.Medical........................................................................................................................................................................87

Cold Sweat Alarm ............................................................................................................................................................................87Helena.Laboratories.Point.of.Care......................................................................................................................................88

ACT Testing ........................................................................................................................................................................................88Plateletworks ............................................................................................................................................................................................................................ 88

Plateletworks ADP Kit and Plateletworks Collagen Kit ........................................................................................................................................................................88Actalyke Analysers ..................................................................................................................................................................................................................... 89

Actalyke XL ...........................................................................................................................................................................................................................................89FOB Testing ........................................................................................................................................................................................89

ColoScreen-ES ............................................................................................................................................................................................................................ 89ColoCARE (Home Use) ................................................................................................................................................................................................................ 89

©Espicom Business Intelligence June 2006x


ColoCARE (Physician’s Office).....................................................................................................................................................................................................90ColoCARE (Hospital Pack) ..........................................................................................................................................................................................................90

Hema.Diagnostic.Systems.................................................................................................................................................. 90RAPID 1-2-3 HEMA ............................................................................................................................................................................90

Rapid 1-2-3 HEMA HIV Test ........................................................................................................................................................................................................91In Development ................................................................................................................................................................................91

West Nile Virus ...........................................................................................................................................................................................................................91HemoCue.AB.........................................................................................................................................................................92

HemoCue Haemoglobin Systems .................................................................................................................................................92HemoCue Plasma/Low Hb ..............................................................................................................................................................93HemoCue Urine Albumin ................................................................................................................................................................93HemoCue 201 DM Systems .............................................................................................................................................................93

HemoSense.......................................................................................................................................................................... 94Coagulation Monitoring .................................................................................................................................................................94

INRatio Prothrombin Time Monitoring System .......................................................................................................................................................................94Agreements .......................................................................................................................................................................................94

Reliant Healthcare Solutions ....................................................................................................................................................................................................94ZyCare .........................................................................................................................................................................................................................................95IDEO ............................................................................................................................................................................................................................................95St Jude Medical ..........................................................................................................................................................................................................................95

Home.Access.Health.Corporation...................................................................................................................................... 96Horiba.ABX........................................................................................................................................................................... 97

Clinical Chemistry Analysers ..........................................................................................................................................................97ABX Pentra 400 ..........................................................................................................................................................................................................................97ABX Mira .....................................................................................................................................................................................................................................98

Hypoguard.(a.Medisys.company)...................................................................................................................................... 98Urinalysis ...........................................................................................................................................................................................98

DiaScreen 50 Urine Chemistry Analyser ....................................................................................................................................................................................98DiaScreen Reagent Strips for Urinalysis ...................................................................................................................................................................................99DiaScreen OTC Test Strips ...........................................................................................................................................................................................................99

iND.Diagnostic..................................................................................................................................................................... 99Pregnancy Tests ................................................................................................................................................................................99

Early Home Pregnancy Test ......................................................................................................................................................................................................99One-Step hCG Urine .................................................................................................................................................................................................................100One-Step Combo hCG...............................................................................................................................................................................................................100One-Step Semi-Quantitative hCG............................................................................................................................................................................................100

Infectious Disease Tests (Hepatitis B, Hepatitis C and HIV) ................................................................................................... 100Sexually Transmitted Disease Test (Syphilis, Gonorrhoea) ....................................................................................................101Tumour Marker Tests (AFP, PSA, FOB) .........................................................................................................................................101Cardiac Marker Tests ......................................................................................................................................................................101Drugs-of-abuse tests (MOP, COC, THC, MET, AMP)...................................................................................................................102Urinalysis Reagent Tests ...............................................................................................................................................................102

instant.Technologies......................................................................................................................................................... 102Drug Testing ....................................................................................................................................................................................102

iScreen OFD ..............................................................................................................................................................................................................................103IScreen Oral ..............................................................................................................................................................................................................................103Icup ...........................................................................................................................................................................................................................................103iScreen ODC ..............................................................................................................................................................................................................................104iScreen Cassette .......................................................................................................................................................................................................................104

Pregnancy and Ovulation ............................................................................................................................................................ 104IPregnancy Test ........................................................................................................................................................................................................................104

Clinical Diagnostics ........................................................................................................................................................................105

©Espicom Business Intelligence xiJune 2006


iScreen H. pylori .......................................................................................................................................................................................................................105iScreen Mono ...........................................................................................................................................................................................................................105iStrep A-Rapid Test ...................................................................................................................................................................................................................105

Alcohol Screening ..........................................................................................................................................................................105QED A150 ..................................................................................................................................................................................................................................105AlcoScreen Saliva Test Strip .....................................................................................................................................................................................................105BreathScan Alcohol Tests BS02, BS04, BS08 and BS10 ...........................................................................................................................................................106

Validity Screens and Adulteration ..............................................................................................................................................106instrumentation.Laboratory............................................................................................................................................ 106

Blood Gas/ CO-Oximetry/ Electrolytes/ Metabolites ..............................................................................................................107GEM Premier 3000 ...................................................................................................................................................................................................................107

Coagulation .....................................................................................................................................................................................107GEM PCL Plus Coagulation System ..........................................................................................................................................................................................107

CO-Oximetry ...................................................................................................................................................................................108GEM OPL Oxygenation Portable Laboratory ...........................................................................................................................................................................108

Information Management ............................................................................................................................................................108Integrated HIS/LIS Connection ...............................................................................................................................................................................................108Meets Regulatory Requirements ...........................................................................................................................................................................................108Comprehensive Reports ..........................................................................................................................................................................................................109

Analyser Data Capture .......................................................................................................................................................................................................................109Intuitive ...................................................................................................................................................................................................................................109Platform ...................................................................................................................................................................................................................................109IMPACT Report Writer ..............................................................................................................................................................................................................109

Litigation ..........................................................................................................................................................................................109Bio-Rad Laboratories ...............................................................................................................................................................................................................109

international.Technidyne.Corp.........................................................................................................................................110Hospital POC Coagulation ............................................................................................................................................................110

Hemochron .............................................................................................................................................................................................................................. 110Instrument Test Menu ............................................................................................................................................................................................................ 111Instruments .............................................................................................................................................................................................................................. 111

Signature Elite ................................................................................................................................................................................................................................... 111Signature+ ........................................................................................................................................................................................................................................ 111Signature ............................................................................................................................................................................................................................................ 112Hospital POC Blood Gas ................................................................................................................................................................112

IRMA TRUpoint ......................................................................................................................................................................................................................... 112IRMA TRUpoint Accessories .................................................................................................................................................................................................... 113

IRMA Capillary Collection Device ........................................................................................................................................................................................................ 113Response .................................................................................................................................................................................................................................. 113Optional RxDx Dosing System ................................................................................................................................................................................................. 113

Alternate Site Diagnostics ............................................................................................................................................................113ProTime Microcoagulation System ......................................................................................................................................................................................... 113ProTime Patient Self-Testing ................................................................................................................................................................................................... 114

Haemoglobin Testing ....................................................................................................................................................................114Hgb Pro .................................................................................................................................................................................................................................... 114

Agreements .....................................................................................................................................................................................114Medical Automation Systems ................................................................................................................................................................................................. 114

inverness.Medical.innovations.........................................................................................................................................115Infectious Disease Tests ................................................................................................................................................................115

Binax Products ......................................................................................................................................................................................................................... 115NOW Filariasis Test ............................................................................................................................................................................................................................. 115NOW Flu A and NOW Flu B Tests ........................................................................................................................................................................................................ 116BinaxNOW Influenza A & B Test ........................................................................................................................................................................................................ 116

©Espicom Business Intelligence June 2006xii


Avian Influenza Claim ........................................................................................................................................................................................................................116NOW Legionella Urinary Antigen Test.................................................................................................................................................................................................117NOW Malaria Test ...............................................................................................................................................................................................................................117NOW RSV Test ......................................................................................................................................................................................................................................117NOW Strep A Test .................................................................................................................................................................................................................................117NOW Streptococcus pneumoniae Antigen Test ...................................................................................................................................................................................118

Biostar Products ........................................................................................................................................................................................................................118STREP A OIA MAX .................................................................................................................................................................................................................................118BioStar OIA FLU A/B .............................................................................................................................................................................................................................118BioStar OIA RSV ...................................................................................................................................................................................................................................118BioStar Acceava Strep A .......................................................................................................................................................................................................................118BioStar Acceava Mono .........................................................................................................................................................................................................................118BioStar OIA CdTOX A ............................................................................................................................................................................................................................119BioStar Acceava H. pylori .....................................................................................................................................................................................................................119ImmunoCard STAT! Rotavirus ..............................................................................................................................................................................................................119BioStar OIA STREP B .............................................................................................................................................................................................................................119BioStar OIA CHLAMYDIA ..................................................................................................................................................................................................................... 120BioStar OIA GC .................................................................................................................................................................................................................................... 120

Clearview ................................................................................................................................................................................................................................. 120Clearview Chlamydia ......................................................................................................................................................................................................................... 120Clearview Mono-plus II ......................................................................................................................................................................................................................121Clearview Strep A Exact .......................................................................................................................................................................................................................121Clearview C. Diff A ..............................................................................................................................................................................................................................121Clearview RSV .....................................................................................................................................................................................................................................121Clearview H. pylori II ............................................................................................................................................................................................................................121

Wampole .................................................................................................................................................................................................................................. 122Wampole PreVue B. burgdorferi ........................................................................................................................................................................................................ 122Wampole Rubella-plus ...................................................................................................................................................................................................................... 122Fertility/Pregnancy ........................................................................................................................................................................122

Clearview hCG .......................................................................................................................................................................................................................... 122Cardiology Diagnostics .................................................................................................................................................................122

Clearview Simplify D-dimer .................................................................................................................................................................................................... 122FOB Testing ......................................................................................................................................................................................123

Clearview ULTRA FOB ............................................................................................................................................................................................................... 123Haematocrit Testing ......................................................................................................................................................................123

STAT-CRIT .................................................................................................................................................................................................................................. 123Consumer Diagnostics - Fertility/Pregnancy ............................................................................................................................123

Clearblue ...................................................................................................................................................................................................................................124Recent Acquisitions .......................................................................................................................................................................125

Clondiag ................................................................................................................................................................................................................................... 125Lateral Flow Immunoassay Products – ACON Laboratories .................................................................................................................................................. 125Thermo BioStar ........................................................................................................................................................................................................................ 125Innogenetics Diagnostica Y Terapeutica, S.A.U ......................................................................................................................................................................126Binax ..........................................................................................................................................................................................................................................126Ischemia Technologies ..............................................................................................................................................................................................................126

Agreements .....................................................................................................................................................................................126Bayer Diagnostics .....................................................................................................................................................................................................................126ITI Scotland Limited ..................................................................................................................................................................................................................126

iris.international.................................................................................................................................................................126iChem100 Urine Chemistry Analyser ........................................................................................................................................................................................127

Lifestream.Technologies...................................................................................................................................................127Lifestream Cholesterol Monitor ..................................................................................................................................................127

©Espicom Business Intelligence xiiiJune 2006


Lifestream Technologies Total Cholesterol Test Strips ........................................................................................................................................................... 128Agreements .....................................................................................................................................................................................128

Polymer Technology Systems .................................................................................................................................................................................................. 128GenExel-Sein .............................................................................................................................................................128

Development Project ....................................................................................................................................................................129Lifestyle.Choices.Ltd...........................................................................................................................................................129

Triple Hormone Ovarian Reserve Test ........................................................................................................................................129Plan Ahead ............................................................................................................................................................................................................................... 129

Matritech.............................................................................................................................................................................130Bladder Cancer Test .......................................................................................................................................................................130

NMP22 BladderChek Test ........................................................................................................................................................................................................ 130NMP22 Test Kit ........................................................................................................................................................................................................................ 130

In Development .............................................................................................................................................................................. 131Breast Cancer Test .....................................................................................................................................................................................................................131

Cervical Cancer Test ....................................................................................................................................................................... 131Prostate Cancer Test ...................................................................................................................................................................... 131Colon Cancer Test ...........................................................................................................................................................................132

MedCap.Corp......................................................................................................................................................................132AccuScan ..........................................................................................................................................................................................132

AccuScan Heroin/Morphine .....................................................................................................................................................................................................132Syphilis Test Kit ......................................................................................................................................................................................................................... 133

Development Project ....................................................................................................................................................................133Avian Flu Test Kit ...................................................................................................................................................................................................................... 133

Chinese Joint Venture ...................................................................................................................................................................133Medical.Automation.Systems...........................................................................................................................................134

RALS-Plus ........................................................................................................................................................................................134RALS eQuiz ......................................................................................................................................................................................135RALS-TGCM ......................................................................................................................................................................................135RALS-Report ....................................................................................................................................................................................135Agreements .....................................................................................................................................................................................135

International Technidyne Corporation ................................................................................................................................................................................... 135Radiometer .............................................................................................................................................................................................................................. 135

Acquisitions .....................................................................................................................................................................................136The Epsilon Group .................................................................................................................................................................................................................... 136

MedMira.Laboratories........................................................................................................................................................136HIV Tests ...........................................................................................................................................................................................137

MiraCare HIV .............................................................................................................................................................................................................................137Reveal Rapid HIV-1 Antibody Test ............................................................................................................................................................................................137MedMira Rapid HIV ...................................................................................................................................................................................................................137MiraWell Rapid HIV Test ...........................................................................................................................................................................................................137

Hepatitis B, HIV and Hepatitis C Test ..........................................................................................................................................137MiraWell3 HBV, HIV, HCV .........................................................................................................................................................................................................137

HIV and Hepatitis C Test ................................................................................................................................................................137MiraWell2 HIV, HCV ...................................................................................................................................................................................................................137

Hepatitis B Test ...............................................................................................................................................................................137MiraWell Rapid HBV Test ..........................................................................................................................................................................................................137

Hepatitis C Test ...............................................................................................................................................................................138MiraWell Rapid HCV Test ......................................................................................................................................................................................................... 138

H. pylori Test ...................................................................................................................................................................................138MiraWellhp Test ....................................................................................................................................................................................................................... 138

Menarini.Diagnostics.........................................................................................................................................................138Medtronic............................................................................................................................................................................139

©Espicom Business Intelligence June 2006xiv


ACT Plus Automated Coagulation Timer System .....................................................................................................................139HMS PLUS Haemostasis Management System ........................................................................................................................139

Mitsubishi.Kagaku.iatron.(MKi)........................................................................................................................................140Cardiac Infarction Test ...................................................................................................................................................................140

Pathfast ................................................................................................................................................................................................................................... 140Food Allergy Test ............................................................................................................................................................................140

Immufast Check J2 ................................................................................................................................................................................................................... 140Meridian.Bioscience...........................................................................................................................................................141

C.difficile Test .................................................................................................................................................................................. 141ImmunoCard Toxins A&B ..........................................................................................................................................................................................................141

H. pylori Test ....................................................................................................................................................................................142ImmunoCard STAT! HPSA..........................................................................................................................................................................................................142

RSV Test ............................................................................................................................................................................................142ImmunoCard STAT! RSV Plus ....................................................................................................................................................................................................142

Strep A Test ......................................................................................................................................................................................142ImmunoCard STAT! Strep A .......................................................................................................................................................................................................142

N-Dia.inc..............................................................................................................................................................................142Non-Invasive Test for ROM ...........................................................................................................................................................142

AmniSure ..................................................................................................................................................................................................................................142Products in Development .........................................................................................................................................................................................................143

Nanogen..............................................................................................................................................................................143Test for CHF .....................................................................................................................................................................................144

StatusFirst CHF NT-proBNP ..................................................................................................................................................................................................... 144Tests for ACS and AMI ....................................................................................................................................................................144In Development ..............................................................................................................................................................................145

Nexus DX Traumatic Brain Injury Test ...................................................................................................................................................................................... 145Acquisitions .....................................................................................................................................................................................145

Spectral Diagnostics ................................................................................................................................................................................................................ 145Agreements .....................................................................................................................................................................................145

Nova.Biomedical.................................................................................................................................................................146Blood Gas Critical Care Analysers ................................................................................................................................................146

Stat Profile Critical Care Xpress (CCX) ...................................................................................................................................................................................... 146Stat Profile pHOx Series ........................................................................................................................................................................................................... 146Nova 16: Whole Blood Chem 7 Plus Haematocrit for Point of Care .........................................................................................................................................147

Data Management .........................................................................................................................................................................147Patient Data Manager (PDM) ...................................................................................................................................................................................................147

Agreements .....................................................................................................................................................................................148E-Z-EM ..................................................................................................................................................................................................................................... 148

Supply Agreements .......................................................................................................................................................................149Premier ......................................................................................................................................................................................................................................149Novation ....................................................................................................................................................................................................................................149

Omega.Pharma...................................................................................................................................................................149Pregnancy Test ...............................................................................................................................................................................149

Predictor ....................................................................................................................................................................................................................................149OraSure.Technologies........................................................................................................................................................150

HIV Tests ...........................................................................................................................................................................................150OraQuick ADVANCE .................................................................................................................................................................................................................. 150

Drugs of Abuse ............................................................................................................................................................................... 151Q.E.D. Saliva Alcohol Test ..........................................................................................................................................................................................................151

Supply Agreements ....................................................................................................................................................................... 151Novation ....................................................................................................................................................................................................................................151

Orion.Diagnostica...............................................................................................................................................................151

©Espicom Business Intelligence xvJune 2006


Point-of-Care Tests .........................................................................................................................................................................152QuikRead System .....................................................................................................................................................................................................................152

QuikRead 101 Instrument ..................................................................................................................................................................................................................152QuikRead CRP .....................................................................................................................................................................................................................................152QuikRead U-ALB .................................................................................................................................................................................................................................152QuikRead FOB ....................................................................................................................................................................................................................................152

Rotaviral and Adenoviral Enteritis Test ...................................................................................................................................................................................153Diarlex MB ..........................................................................................................................................................................................................................................153

Urinary Tract Infection Test .....................................................................................................................................................................................................153Uricult .................................................................................................................................................................................................................................................153

OrSense.............................................................................................................................................................................. 154Haemoglobin Monitoring ............................................................................................................................................................154

OrSense Advantages in the Haemoglobin Monitoring Market .............................................................................................................................................154Applications of OrSense Blood Monitoring Solutions ............................................................................................................................................................154Summary of OrSense Critical Care Benefits ............................................................................................................................................................................155Applications in Outpatient Clinics ...........................................................................................................................................................................................155Summary of OrSense Benefits for Clinics ................................................................................................................................................................................155Haemoglobin Measurement – Clinical Results ......................................................................................................................................................................156

Ortho-Clinical.Diagnostics............................................................................................................................................... 156Clinical Chemistry Analyser ..........................................................................................................................................................156

VITROS DT60 II Chemistry System ...........................................................................................................................................................................................157Derived Tests: ......................................................................................................................................................................................................................................157

VITROS dHDL Slide ...................................................................................................................................................................................................................157Osmetech............................................................................................................................................................................ 158

Blood Gas Analysis .........................................................................................................................................................................158OPTI CCA Touch.........................................................................................................................................................................................................................159OPTI R .......................................................................................................................................................................................................................................159OPTI LION ..................................................................................................................................................................................................................................159

Point-Of-Care CO-Oximeter .........................................................................................................................................................159AVOXimeter 4000 .....................................................................................................................................................................................................................159

Data Management ........................................................................................................................................................................ 160DataTrol ....................................................................................................................................................................................................................................160

PreMD.inc........................................................................................................................................................................... 160PREVU Point of Care Skin Sterol Test ..........................................................................................................................................161

Predictor of Advanced Subclinical Atherosclerosis (PASA) Study ..........................................................................................................................................161Cancer Tests .....................................................................................................................................................................................162

ColorectAlert ............................................................................................................................................................................................................................162LungAlert .................................................................................................................................................................................................................................163Breast Cancer Test ....................................................................................................................................................................................................................163

PreMD’s Objectives for Fiscal 2006 ............................................................................................................................................ 164Polymer.Technology.Systems.(PTS)................................................................................................................................. 165

CardioChek Systems .....................................................................................................................................................................165CardioChek P.A System (Professional System) ........................................................................................................................................................................165

PTS Panels Test Strips..........................................................................................................................................................................................................................165CardioChek (Consumer System) ..............................................................................................................................................................................................165

Prima.Biomedical............................................................................................................................................................... 166One Step Rapid Tests .................................................................................................................................................................... 166

Fertility Tests ............................................................................................................................................................................................................................166Tumour Marker Tests ...............................................................................................................................................................................................................166Hepatitis Tests ..........................................................................................................................................................................................................................166Infectious Disease Tests ...........................................................................................................................................................................................................166Cardiac Marker Tests ................................................................................................................................................................................................................167

©Espicom Business Intelligence June 2006xvi


Miscellaneous Tests .................................................................................................................................................................................................................167Drugs-of-abuse tests ...............................................................................................................................................................................................................167Drug Adulteration Strips ..........................................................................................................................................................................................................167

Quantitative Rapid Tests ...............................................................................................................................................................167Quantitative Fertility Tests ......................................................................................................................................................................................................167Quantitative Tumour Marker Tests ..........................................................................................................................................................................................167

Urinalysis ..........................................................................................................................................................................................167Multi UrinScreen Devices .........................................................................................................................................................................................................167

Blood Glucose Rapid Tests ........................................................................................................................................................... 168Instruments .................................................................................................................................................................................... 168

Rapid Test Readers ...................................................................................................................................................................................................................168F-100 Urine Strip Readers ........................................................................................................................................................................................................168

Princeton.BioMeditech..................................................................................................................................................... 169Pregnancy Tests ..............................................................................................................................................................................169

BioSign hCG - One Step Pregnancy Test and LifeSign Plus - One Step Home Pregnancy Test ..............................................................................................169LifeSign 1 - One Step Home Pregnancy "Mid-stream" Stick Test ..........................................................................................................................................169

Infectious Disease Tests ................................................................................................................................................................170BioSign .....................................................................................................................................................................................................................................170

BioSign Antigen Detection Tests: ........................................................................................................................................................................................................170BioSign Antibody Detection Tests: ......................................................................................................................................................................................................170Drugs-of-abuse tests .....................................................................................................................................................................171

AccuSign ..................................................................................................................................................................................................................................171Tumour Marker Tests .....................................................................................................................................................................171

Rapid Tumour Marker Tests .....................................................................................................................................................................................................171Cardiac Marker Tests ......................................................................................................................................................................172

LifeSign .....................................................................................................................................................................................................................................172Agreements .....................................................................................................................................................................................173

Nanogen ..................................................................................................................................................................................................................................173Beckman Coulter ......................................................................................................................................................................................................................173

Probe.Scientific...................................................................................................................................................................173Blood Analysis device ....................................................................................................................................................................173

MicroEYE ..................................................................................................................................................................................................................................173Proteome.Systems..............................................................................................................................................................175

DiagnostIQ ......................................................................................................................................................................................175Rapid point-of-care test to detect TB .........................................................................................................................................175

Provalis.Diagnostics...........................................................................................................................................................176in2it analyser ..................................................................................................................................................................................177

in2it A1C test ............................................................................................................................................................................................................................177Glycosal HbA1c Test ..................................................................................................................................................................................................................177

Osteoporosis (Bone markers) .......................................................................................................................................................177CrossLaps ..................................................................................................................................................................................................................................177Osteosal ....................................................................................................................................................................................................................................177

H.pylori Test .....................................................................................................................................................................................178Helisal One Step .......................................................................................................................................................................................................................178

Agreements .....................................................................................................................................................................................178Cholestech ................................................................................................................................................................................................................................178

Quidel.Corporation.............................................................................................................................................................178Infectious Diseases ........................................................................................................................................................................179

Influenza ..................................................................................................................................................................................................................................179QuickVue Influenza ............................................................................................................................................................................................................................179QuickVue Influenza A+B test .............................................................................................................................................................................................................179QuickVue Strep A ................................................................................................................................................................................................................................179

©Espicom Business Intelligence xviiJune 2006


QuickVue H. pylori gII .........................................................................................................................................................................................................................180QuickVue Infectious Mononucleosis ...................................................................................................................................................................................................180Reproductive Health .................................................................................................................................................................... 180

Pregnancy ................................................................................................................................................................................................................................180QuickVue One-Step hCG Combo .........................................................................................................................................................................................................180QuickVue One-Step hCG Urine ............................................................................................................................................................................................................180QuickVue Semi-Q hCG Combo ............................................................................................................................................................................................................181RapidVue hCG .....................................................................................................................................................................................................................................181

Chlamydia ................................................................................................................................................................................................................................181QuickVue Chlamydia Test ...................................................................................................................................................................................................................181QuickVue Advance G. Vaginalis Test ...................................................................................................................................................................................................182QuickVue iFOB test .............................................................................................................................................................................................................................182Bone Health and Oncology ..........................................................................................................................................................182

Bone Health .............................................................................................................................................................................................................................182Development Projects...................................................................................................................................................................182Agreements .....................................................................................................................................................................................183

Dade Behring ...........................................................................................................................................................................................................................183Church & Dwight ......................................................................................................................................................................................................................183

Acquisitions .....................................................................................................................................................................................183IFOB Test ...................................................................................................................................................................................................................................183

radiometer........................................................................................................................................................................ 184Blood Gas Analysis ........................................................................................................................................................................ 184

1st automatic .............................................................................................................................................................................................................................184ABL77 .......................................................................................................................................................................................................................................185NPT7 .........................................................................................................................................................................................................................................186ABL700 .....................................................................................................................................................................................................................................186ABL5 .........................................................................................................................................................................................................................................186

Quality Control .............................................................................................................................................................................. 186QUALICHECK+ ..........................................................................................................................................................................................................................187AutoCheck ................................................................................................................................................................................................................................187

Analyser Management Systems ................................................................................................................................................. 188RADIANCE ................................................................................................................................................................................................................................188FLEXLINK ...................................................................................................................................................................................................................................188

Agreements .................................................................................................................................................................................... 188Medical Automation Systems .................................................................................................................................................................................................188

Group Purchasing Organisation (GPO) Partners ..................................................................................................................... 189Premier .....................................................................................................................................................................................................................................189Veterans Integrated Services Network ...................................................................................................................................................................................189Consorta ...................................................................................................................................................................................................................................189

remel.................................................................................................................................................................................. 190Xpect Flu A&B Test ........................................................................................................................................................................ 190Xpect RSV Test ............................................................................................................................................................................... 190Oxoid PBP2 Test ..............................................................................................................................................................................191

response.Biomedical.Corp............................................................................................................................................... 191RAMP System ..................................................................................................................................................................................192Cardiac Markers ..............................................................................................................................................................................192

RAMP Troponin I Assay ............................................................................................................................................................................................................192Influenza ..........................................................................................................................................................................................192

RAMP Flu A Test .......................................................................................................................................................................................................................192Agreements .....................................................................................................................................................................................193

Shionogi ...................................................................................................................................................................................................................................1933M Medical Division ................................................................................................................................................................................................................193

©Espicom Business Intelligencexviii


LXU Healthcare ...............................................................................................................................................................................194roche.Diagnostics..............................................................................................................................................................194

Roche POC Diagnostics Sales, 2004-2005 (US$ million) .................................................................................................................................................................... 195Coagulation Monitoring Systems ...............................................................................................................................................195

CoaguChek Systems ..................................................................................................................................................................................................................195Hospital Blood Gas/Electrolytes ..................................................................................................................................................196COMPACT 3 ......................................................................................................................................................................................196cobas b 121 ......................................................................................................................................................................................196cobas b 221 .....................................................................................................................................................................................196

Roche 9180 Electrolyte Analyser ..............................................................................................................................................................................................197Cardiac Markers .............................................................................................................................................................................. 197

Cardiac Reader System .............................................................................................................................................................................................................197Roche Cardiac Test Strips ..........................................................................................................................................................................................................198

Multi-parameter Clinical Chemistry Analysers.........................................................................................................................198Reflotron Systems .....................................................................................................................................................................................................................198

Reflotron Plus .................................................................................................................................................................................................................................... 198Reflotron sprint .................................................................................................................................................................................................................................. 198Urinalysis ..........................................................................................................................................................................................198

Urisys 1100 Urine Analyser .......................................................................................................................................................................................................198Combur-Test Strips/Chemstrips ...............................................................................................................................................................................................199

Point of Care Data Management ................................................................................................................................................199cobas IT 1000 solution ..............................................................................................................................................................................................................199

2005: Roche Sales ...........................................................................................................................................................................200Diabetes Care and Near Patient Testing Segments, Sales by Region and Business Area* ................................................................................................... 200

rohto.Pharmaceutical........................................................................................................................................................201Pregnancy Test Kit..........................................................................................................................................................................201

Dotest hCG Plus ........................................................................................................................................................................................................................201Ovulation Test Kit ...........................................................................................................................................................................201

Dotest LH ...................................................................................................................................................................................................................................201runbio.Biotech....................................................................................................................................................................201

Fertility Tests ...................................................................................................................................................................................202One Step hCG Pregnancy Test ...................................................................................................................................................................................................202One-Step LH Ovulation Tests ....................................................................................................................................................................................................202

Key Features: ...................................................................................................................................................................................................................................... 202One-Step FSH Menopause Test.................................................................................................................................................................................................202

Key Features: ...................................................................................................................................................................................................................................... 202Infectious Diseases ........................................................................................................................................................................203

One Step Hepatitis B Tests ....................................................................................................................................................................................................... 203One Step HBsAg Test ........................................................................................................................................................................................................................... 203One Step HBsAb Test ........................................................................................................................................................................................................................... 203One Step HBeAg Test .......................................................................................................................................................................................................................... 203One Step HBeAb Test ......................................................................................................................................................................................................................... 203One Step HBcAb Test .......................................................................................................................................................................................................................... 203

One Step Anti-HCV Test ........................................................................................................................................................................................................... 203One Step Anti-HIV 1+2 Test ..................................................................................................................................................................................................... 203

Tumour Marker Tests .....................................................................................................................................................................203One Step Anti-HIV 1+2 Test ..................................................................................................................................................................................................... 203One Step Carcinoma Embryonic Antigen Test ........................................................................................................................................................................ 204One Step Prostate Specific Antigen Test ................................................................................................................................................................................. 204One-Step Faecal Occult Blood (FOB) Tests .............................................................................................................................................................................. 204

Sexually-Transmitted Disease Tests ...........................................................................................................................................204One Step Anti-Syphilis Test ..................................................................................................................................................................................................... 204

June 2006

©Espicom Business Intelligence xixJune 2006


One Step Gonorrhoea Test ...................................................................................................................................................................................................... 204Drugs-of-abuse tests ....................................................................................................................................................................204

One Step Morphine Test.......................................................................................................................................................................................................... 204One Step Cocaine Test ............................................................................................................................................................................................................. 204One Step Marijuana Test ......................................................................................................................................................................................................... 205One Step Amphetamine Test ................................................................................................................................................................................................. 205One Step Methamphetamine Test ......................................................................................................................................................................................... 205

SA.Scientific........................................................................................................................................................................205Fertility ............................................................................................................................................................................................206

Pregnancy ............................................................................................................................................................................................................................... 206Ovulation (not FDA approved) ................................................................................................................................................................................................ 206FSH (Menopause) (not FDA approved) ................................................................................................................................................................................... 206

Infectious Diseases .......................................................................................................................................................................206Diagnostic test for Respiratory Syncytial Virus (RSV) (CLIA: Waived and Moderate) ..................................................................................206Influenza A & B Rapid Test (CLIA waiver pending) .................................................................................................................................................. 206Legionella Test ........................................................................................................................................................................................................................ 206Strep A ..................................................................................................................................................................................................................................... 207

Sienco.................................................................................................................................................................................207Platelet Function Analyser ..........................................................................................................................................................207

Sonoclot................................................................................................................................................................................................................................... 207Data Management ........................................................................................................................................................................207

Signature Viewer .................................................................................................................................................................................................................... 207Stanbio.Laboratory...........................................................................................................................................................208

Haematology Analysers ...............................................................................................................................................................208HemoPoint H2 ......................................................................................................................................................................................................................... 208STAT-Site MHgb ....................................................................................................................................................................................................................... 208STAT-Site Analyser-Ketone Meter ........................................................................................................................................................................................... 208

Pregnancy Testing ........................................................................................................................................................................209QuPID and QuPID Plus ............................................................................................................................................................................................................. 209True 20 .................................................................................................................................................................................................................................... 209QuSTICK ................................................................................................................................................................................................................................... 209

Urinalysis .........................................................................................................................................................................................209UriTrak 100 ............................................................................................................................................................................................................................. 209

Infectious Diseases .......................................................................................................................................................................209QuStick Strep A ........................................................................................................................................................................................................................ 209EZ-Well Strep A .........................................................................................................................................................................................................................210

Syntron.Bioresearch.......................................................................................................................................................... 210Blood Glucose Testing .................................................................................................................................................................. 210

Glucose Vision ..........................................................................................................................................................................................................................210Drugs-of-abuse testing ................................................................................................................................................................ 210

QuikScreen Drug Test ...............................................................................................................................................................................................................210Saliva Screen 5 Test ..................................................................................................................................................................................................................211

Cholesterol Tests ........................................................................................................................................................................... 211Venture Total Cholesterol Test .................................................................................................................................................................................................211

Fertility Tests .................................................................................................................................................................................. 211Sysmex................................................................................................................................................................................ 211

Haematology Analyser................................................................................................................................................................. 212pocH-100i ................................................................................................................................................................................................................................212

Coagulation Analysers ................................................................................................................................................................. 213CA-50 ........................................................................................................................................................................................................................................213

Development Projects.................................................................................................................................................................. 213Telcor.................................................................................................................................................................................. 214

©Espicom Business Intelligencexx

TablESMeasured Parameters ....................................................................................................................................................................33Sample Volumes ..............................................................................................................................................................................33Parameters .......................................................................................................................................................................................35Sample Volume ................................................................................................................................................................................36Key Features: ...................................................................................................................................................................................202

CharTSPOCT Relative to the Global In Vitro Diagnostics Market, 2005 ................................................................................................1Global POCT Market by Region, 2005 (Global Market = US$10.6 billion) ................................................................................3European* POCT Market by Region, 2005 (Market = US$3.0 billion) .......................................................................................3Roche POC Diagnostics Sales, 2004-2005 (US$ million) .........................................................................................................195

Point Of Care Testing (POCT) Information System ..................................................................................................................214Quick-Linc and QML .................................................................................................................................................................................................................214

Tosoh.Bioscience................................................................................................................................................................215Benchtop Immunoassay Analysers ............................................................................................................................................215

AIA-360 ....................................................................................................................................................................................................................................215AIA-600 II ........................................................................................................................................................................................................215

Trinity.Biotech.....................................................................................................................................................................216POC Infectious Disease Tests ........................................................................................................................................................216

Uni-Gold Recombigen HIV .......................................................................................................................................................................................................216Comparison of POC HIV Tests .............................................................................................................................................................................................................217

Uni-Gold H. pylori Test ............................................................................................................................................................................................................. 217Uni-Gold Malaria ...................................................................................................................................................................................................................... 217Uni-Gold RSV ........................................................................................................................................................................................................................... 217

POC Pregnancy ...............................................................................................................................................................................218Uni-Gold hCG One Step Pregnancy .........................................................................................................................................................................................218

via.Medical..........................................................................................................................................................................218VIA Blood Gas and Chemistry Monitor .......................................................................................................................................219VIA LVM Neonatal System ........................................................................................................................................................... 220VIA Blood Glucose Monitoring System ..................................................................................................................................... 220

wayPoint.Biomedical........................................................................................................................................................ 220OTC Market ......................................................................................................................................................................................221

Health Essist COC-THC Home Drug Tests .................................................................................................................................................................................221Health Essist Multi-Drug Cup...................................................................................................................................................................................................221Drink Detective, Rape Drug Test ..............................................................................................................................................................................................221

Point of Care Diagnostics ............................................................................................................................................................. 222Professional Point of Care Tests .................................................................................................................................................. 222

Multi-Drug-9-Plus and Multi-Drug-11 ...................................................................................................................................................................................222International Products ................................................................................................................................................................. 222

Tropical Disease ........................................................................................................................................................................................................................222Infectious Diseases and Other Rapid Tests ..............................................................................................................................................................................222

Agreements .................................................................................................................................................................................... 223Arben Biosciences ....................................................................................................................................................................................................................223

Point of Care Diagnostics .............................................................................................................................................................................. 224

June 2006


Volume II

market SectorS

©espicom Business Intelligence June 2006ii

Point of care Diagnostics


June 2006

ISBN: 1 85822 261 3

© copyright 2006 espicom Business Intelligence Publications limited

all rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of

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©espicom Business Intelligence iiiJune 2006

Point of care Diagnostics table of contents

CONTENTSOverview.......................................................................................................................................................1

POCT Relative to the Global In Vitro Diagnostics Market, 2005 .............................................................................................................................................................1Global POCT Market by Region, 2005 (Global Market = US$10.6 billion) .............................................................................................................................................3European* POCT Market by Region, 2005 (Market = US$3.0 billion) ...................................................................................................................................................4

GrOwth.Drivers..........................................................................................................................................5economic.Pressure.................................................................................................................................................................5Clinical.Outcomes...................................................................................................................................................................5social.Pressure........................................................................................................................................................................5industry.Pressure...................................................................................................................................................................5technology.Advancements...................................................................................................................................................6

ChAllenGes.tO.POC......................................................................................................................................7Cost.issues...............................................................................................................................................................................7Accuracy..................................................................................................................................................................................7interfacing/Connectivity.issues............................................................................................................................................7regulatory.Compliance.and.Quality.Control.......................................................................................................................7Central.laboratory.Competition..........................................................................................................................................8location.of.POCt.Devices......................................................................................................................................................8

Future.ADvAnCes.in.POC............................................................................................................................9BlOOD.GluCOse.MArKet...........................................................................................................................10

Blood Glucose Monitoring Market Leaders, 2004/2005 ......................................................................................................................................................................10Leading Manufacturers’ Diabetes Care Revenues 2004-2005 (US$ million) ....................................................................................................................................... 11

EMERGING TECHNOLOGIES IN BLOOD GLUCOSE TESTING ..............................................................................................13Abbott.Diabetes.Care...........................................................................................................................................................13

FreeStyle Navigator Continuous Glucose Monitor ................................................................................................................... 14FreeStyle Navigator - design ..................................................................................................................................................................................................... 14

Advanced.Biosensors...........................................................................................................................................................15Continuous Glucose Monitoring Device (Messenger) ............................................................................................................... 15

AiMedics................................................................................................................................................................................16HypoMon ...........................................................................................................................................................................................16Clinical Trial Progress ............................................................................................................................................................................................................................ 16Agreements ....................................................................................................................................................................................... 17

Healthcare Technology Limited ................................................................................................................................................................................................ 17Calisto.Medical......................................................................................................................................................................17Diabetech..............................................................................................................................................................................18

Agreements ....................................................................................................................................................................................... 19Entelos ........................................................................................................................................................................................................................................ 19Zyvex .......................................................................................................................................................................................................................................... 20

Fovi.Optics.............................................................................................................................................................................20Glucolight.Corporation.......................................................................................................................................................21Glucon....................................................................................................................................................................................22

Clinical Trial Progress .......................................................................................................................................................................22In Vivo Preclinical Results .......................................................................................................................................................................................................... 23

GluMetrics.............................................................................................................................................................................23integrity.Applications..........................................................................................................................................................24Kumetrix................................................................................................................................................................................26

Silicon Microtechnology .................................................................................................................................................................26Blood Glucose Monitor ...................................................................................................................................................................26Other Medical Applications............................................................................................................................................................27

lein.Applied.Diagnostics.....................................................................................................................................................27

©espicom Business Intelligence June 2006iv

Point of care Diagnosticstable of contents

King’s College School of Medicine ...............................................................................................................................................28lifescan.(J&J)........................................................................................................................................................................ 28

GlucoWatch G2 Biographer ...........................................................................................................................................................29Animas Glucose Sensor Development Project ...........................................................................................................................29

lightouch.Medical................................................................................................................................................................30luminous.Medical................................................................................................................................................................31isense....................................................................................................................................................................................32Menarini.Diagnostics...........................................................................................................................................................33

GlucoDay S .........................................................................................................................................................................................33Results of Multicentre Evaluation .................................................................................................................................................33

Conclusions.................................................................................................................................................................................................................................34nir.Diagnostics.................................................................................................................................................................... 34

In-Vitro Technologies ......................................................................................................................................................................35In-Vivo Technology ..........................................................................................................................................................................35

GlucoNIR .....................................................................................................................................................................................................................................35Agreements .......................................................................................................................................................................................35

Large Consumer and Hospital Diagnostic Company ................................................................................................................................................................35Boehringer Ingelheim microParts GmbH ................................................................................................................................................................................36Ortho-Clinical Diagnostics .........................................................................................................................................................................................................36

niBGM....................................................................................................................................................................................37Oculir..................................................................................................................................................................................... 38Orsense.................................................................................................................................................................................39

Diabetes Monitor .............................................................................................................................................................................39OrSense Medical Advantages ....................................................................................................................................................................................................39Practical Advantages for HMOs .................................................................................................................................................................................................40

Pelikan.technologies.......................................................................................................................................................... 40Product Pipeline ...............................................................................................................................................................................41

Pelikan Sun ................................................................................................................................................................................................................................. 41Integrated Glucose Monitor....................................................................................................................................................................................................... 41Future Pelikan Products............................................................................................................................................................................................................. 41

Pindi.Products.......................................................................................................................................................................42Non-Invasive Glucose Meter .........................................................................................................................................................42

Precisense............................................................................................................................................................................ 43Update on progress since October 2005 (as at 1st March 2006) ...............................................................................................44

Animal Trials ...............................................................................................................................................................................................................................44Potential immunigenecity of human receptor .....................................................................................................................................................................................44

Human Clinical Trials ..................................................................................................................................................................................................................44PreciSense Milestone Plan – 2006 ................................................................................................................................................45

Intellectual property ..................................................................................................................................................................................................................45sensors.for.Medicine.&.science.......................................................................................................................................... 46

SMSI Glucose Sensor ........................................................................................................................................................................46sontra.Medical..................................................................................................................................................................... 48

Symphony Diabetes Management System ................................................................................................................................48Sontra Medical’s Core Technology - Ultrasound-Mediated Skin Permeation ......................................................................48Upgrade to SonoPrep Device .........................................................................................................................................................49Agreements .......................................................................................................................................................................................49

Bayer – Amendment to Licence Agreement ............................................................................................................................................................................49Study Results .....................................................................................................................................................................................50

spectrx................................................................................................................................................................................. 50Continuous Glucose Monitoring Device .....................................................................................................................................50

synthetic.Blood.international.(sYBD)................................................................................................................................51

©espicom Business Intelligence vJune 2006


Implanted Glucose Biosensor .......................................................................................................................................................51veralight.............................................................................................................................................................................. 52

Scout ...................................................................................................................................................................................................52visual.Pathways................................................................................................................................................................... 53

GlucoScope Monitor .......................................................................................................................................................................53vivoMedical......................................................................................................................................................................... 53vivoPatch............................................................................................................................................................................. 54

Advantages of VivoPatch ...........................................................................................................................................................................................................54The Changing BGM Landscape......................................................................................................................................................54

CURRENT BLOOD GLUCOSE MONITORING SYSTEMS .......................................................................................................5577.electronica.Kft................................................................................................................................................................ 55

Biosensor Glucose Meters ..............................................................................................................................................................55Sensolite .....................................................................................................................................................................................................................................55SensoCard ...................................................................................................................................................................................................................................56SensoCard Plus ...........................................................................................................................................................................................................................56

Optical Glucose Meters ...................................................................................................................................................................56GlucoCare ...................................................................................................................................................................................................................................56Optilite ........................................................................................................................................................................................................................................57

Abbott.Diabetes.Care.......................................................................................................................................................... 57Self-testing Systems ........................................................................................................................................................................57

Precision Xtra..............................................................................................................................................................................................................................57FreeStyle .....................................................................................................................................................................................................................................58FreeStyle Freedom .....................................................................................................................................................................................................................58FreeStyle Flash (FreeStyle Mini) ................................................................................................................................................................................................58Data Management .....................................................................................................................................................................................................................58

FreeStyle CoPilot Health Management System ....................................................................................................................................................................................58Precision Link Management System ....................................................................................................................................................................................................58Point of Care Systems (In the Professional Environment) ........................................................................................................58

FreeStyle Connect Blood Glucose Monitoring System .............................................................................................................................................................58Precision PCx Point-of-Care System ..........................................................................................................................................................................................59Data Management .....................................................................................................................................................................................................................59

Precision Net Point-of-Care Data Networking .....................................................................................................................................................................................59QC Manager Poiint-of-Care Data Management System .....................................................................................................................................................................60Agreements .......................................................................................................................................................................................60Smiths Medical .................................................................................................................................................................................60Supply Agreements .........................................................................................................................................................................60

Premier ......................................................................................................................................................................................................................................60Litigation ............................................................................................................................................................................................61

Becton Dickinson .......................................................................................................................................................................................................................61Dexcom .......................................................................................................................................................................................................................................61

ACOn.laboratories.............................................................................................................................................................. 62On Call Now Blood Glucose Monitoring System ......................................................................................................................................................................62On Call Blood Glucose Visual Strips ...........................................................................................................................................................................................62

Agamatrix............................................................................................................................................................................ 62Wave 1 Blood Glucose Monitoring System .................................................................................................................................62

Apex.Biotechnology............................................................................................................................................................ 63Products ............................................................................................................................................................................................ 64

GlucoSure Plus ...........................................................................................................................................................................................................................64GlucoSure II .................................................................................................................................................................................................................................64GlucoGuard .................................................................................................................................................................................................................................64MultiSure ....................................................................................................................................................................................................................................64

©espicom Business Intelligence June 2006vi


UASure ........................................................................................................................................................................................................................................65Litigation ............................................................................................................................................................................................65

Roche Diagnostics ......................................................................................................................................................................................................................65Arkray................................................................................................................................................................................... 66

Blood Glucose Self-Monitoring Systems .....................................................................................................................................66Glucocard X-Meter .....................................................................................................................................................................................................................66Glucocard II Data (GT-1650) .......................................................................................................................................................................................................66Super Glucocard II (GT-1640) .....................................................................................................................................................................................................67

Bayer.healthcare..................................................................................................................................................................67Self Testing Blood Glucose Monitoring Systems ........................................................................................................................67

Ascensia ......................................................................................................................................................................................................................................67Ascensia Glucofacts Diabetes Management Software ............................................................................................................................................................68Lancing Devices ..........................................................................................................................................................................................................................68

Agreements .......................................................................................................................................................................................68Sontra Medical ...........................................................................................................................................................................................................................68

BD.(Becton.Dickinson)......................................................................................................................................................... 69BD Diabetes Care .............................................................................................................................................................................69

Blood Glucose Monitoring .........................................................................................................................................................................................................69BD Logic Blood Glucose Monitor ..........................................................................................................................................................................................................69

BD Logic and Paradigm Link ......................................................................................................................................................................................................69BD Test Strips ........................................................................................................................................................................................................................................70

BD InterActiv Diabetes Software ..............................................................................................................................................................70Agreements .......................................................................................................................................................................................70

Medtronic MiniMed ..................................................................................................................................................................................................................70DexCom.................................................................................................................................................................................71

DexCom STS Continuous Glucose Monitoring System ............................................................................................................71FCC Waiver ............................................................................................................................................................................................................................................72Clinical Trial Results for STS ..................................................................................................................................................................................................................72

DexCom Long-Term Continuous Glucose Monitoring System ................................................................................................................................................72Litigation ............................................................................................................................................................................................73

Abbott Diabetes Care .................................................................................................................................................................................................................73euMeD.Biotechnology.........................................................................................................................................................74

EUSURE Blood Glucose Monitoring System ................................................................................................................................74Glucoplus...............................................................................................................................................................................75

Glucoplus Glucose Monitoring System ........................................................................................................................................75hMD.Bio.Medical..................................................................................................................................................................75

GlucoLeader Enhance ......................................................................................................................................................................75GlucoLeader Value ..........................................................................................................................................................................76GlucoLab ............................................................................................................................................................................................76

hemoCue.AB.........................................................................................................................................................................76Glucose Systems ..............................................................................................................................................................................77

Glucose 201 Analyzer .................................................................................................................................................................................................................77HemoCue Glucose 201+ ............................................................................................................................................................................................................77

Data Management ...........................................................................................................................................................................77home.Diagnostics,.inc.........................................................................................................................................................78

Sidekick Testing System ..................................................................................................................................................................78TrueTrack Smart System Blood Glucose Monitor .......................................................................................................................78

TrueTrack Smart System Test Strips ...........................................................................................................................................................................................78TrackEASE Smart System Blood Glucose Monitor ......................................................................................................................79Prestige IQ Blood Glucose Monitor ...............................................................................................................................................79

hypoguard............................................................................................................................................................................79

©espicom Business Intelligence viiJune 2006


Professional Blood Glucose Monitoring Systems ......................................................................................................................79Assure Pro ...................................................................................................................................................................................................................................80Assure 3 .....................................................................................................................................................................................................................................80Assure 3 Test Strips with Guide-Me-Curve ...............................................................................................................................................................................80Assure II .....................................................................................................................................................................................................................................80Assure II Test Strips with Guide-Me-Curve ...............................................................................................................................................................................80Assure .........................................................................................................................................................................................................................................81Supreme II ..................................................................................................................................................................................................................................81

Consumer Products .........................................................................................................................................................................81ReliOn NewTek. ..........................................................................................................................................................................................................................81Advance Intuition Blood Glucose Monitoring System .............................................................................................................................................................81Advance Micro-draw .................................................................................................................................................................................................................82QuickTek Blood Glucose System ...............................................................................................................................................................................................82Supreme Plus .............................................................................................................................................................................................................................82

Agreements .......................................................................................................................................................................................82Menarini Diagnostics .................................................................................................................................................................................................................82

Litigation ............................................................................................................................................................................................83Roche Diagnostics ......................................................................................................................................................................................................................83

lifescan.(J&J)....................................................................................................................................................................... 83Consumer Diabetes Care Products ...............................................................................................................................................83

OneTouch UltraSmart ................................................................................................................................................................................................................83OneTouch Ultra Blood Glucose Test Strips – Product Recall .................................................................................................................................................................84OneTouch Ultra Meter – Product Recall ...............................................................................................................................................................................................84

InDuo .........................................................................................................................................................................................................................................84OneTouch Ultra ...........................................................................................................................................................................................................................85OneTouch FastTake/PocketScan/EuroFlash ..............................................................................................................................................................................85OneTouch Profile .......................................................................................................................................................................................................................85OneTouch Basic ..........................................................................................................................................................................................................................85OneTouch SureStep/GlucoTouch/Novo Assist ...........................................................................................................................................................................86OneTouch Horizon ......................................................................................................................................................................................................................86Test Strips ...................................................................................................................................................................................................................................86

OneTouch Ultra Test Strip with FastDraw Design .................................................................................................................................................................................86OneTouch FastTake Test Strips ..............................................................................................................................................................................................................86OneTouch SureStep Test Strips ..............................................................................................................................................................................................................87OneTouch Test Strips .............................................................................................................................................................................................................................87

Diabetes Management Software .............................................................................................................................................................................................87OneTouch Diabetes Management Software .......................................................................................................................................................................................87Hospital Products .............................................................................................................................................................................88

OneTouch Flexx Professional Blood Glucose Monitoring System ............................................................................................................................................88SureStep Pro System ..................................................................................................................................................................................................................88SureStep Hospital Meter ............................................................................................................................................................................................................89OneTouch II Hospital System .....................................................................................................................................................................................................89OneTouch II Data Dock System ..................................................................................................................................................................................................89DataLink Data Management System ........................................................................................................................................................................................89

DataLink Connectivity Solutions ...................................................................................................................................................90DataLink Connect .......................................................................................................................................................................................................................90DataLink Control ........................................................................................................................................................................................................................90DataLink Interface/ISI Software ................................................................................................................................................................................................90

Optional DataLink Modules ...........................................................................................................................................................90DataLink with RALS-Plus ...........................................................................................................................................................................................................91DataLink with QML ....................................................................................................................................................................................................................91

©espicom Business Intelligence June 2006viii


Test Strips ...................................................................................................................................................................................................................................91SureStepPro Test Strips .........................................................................................................................................................................................................................91Agreements .......................................................................................................................................................................................91

Medical Automation Systems ...................................................................................................................................................................................................91Telcor ..........................................................................................................................................................................................................................................91Sangamo BioSciences ................................................................................................................................................................................................................92Novo Nordisk ..............................................................................................................................................................................................................................92InLight Solutions ........................................................................................................................................................................................................................93

Medtronic.Diabetes..............................................................................................................................................................93Guardian RT Continuous Glucose Monitoring System .............................................................................................................93

Guardian RT Pilot Study Results ................................................................................................................................................................................................94CGMS System Gold ...........................................................................................................................................................................94Paradigm Link Blood Glucose Monitor ........................................................................................................................................95

Metrika..................................................................................................................................................................................95A1cNow InView System ...................................................................................................................................................................95

Queststar.Medical............................................................................................................................................................... 96Focus. ..................................................................................................................................................................................................96

roche.Diabetes.Care............................................................................................................................................................97Products .............................................................................................................................................................................................97

Accu-Chek Aviva .........................................................................................................................................................................................................................97Accu-Chek Aviva – Product Recall .......................................................................................................................................................................................................97

Accu-Chek Go .............................................................................................................................................................................................................................98Accu-Chek Compact Plus ..........................................................................................................................................................................................................98Accu-Chek Compact Meter ........................................................................................................................................................................................................98Accu-Chek Active Meter .............................................................................................................................................................................................................98Accu-Chek Advantage Meter .....................................................................................................................................................................................................98Accu-Chek Complete Meter .......................................................................................................................................................................................................99Accu-Chek VoiceMate Meter .....................................................................................................................................................................................................99

Data Management ...........................................................................................................................................................................99Accu-Chek Compass Software ..................................................................................................................................................................................................99Accu-Chek Pocket Compass 3.0 .................................................................................................................................................................................................99Diabetes Assistant Software .....................................................................................................................................................................................................99Hospital Glucose Monitoring Systems ....................................................................................................................................................................................100

Accu-Chek Inform ...............................................................................................................................................................................................................................100Accutrend Systems .............................................................................................................................................................................................................................100Agreements .....................................................................................................................................................................................100

invivodata.................................................................................................................................................................................................................................100MedAssets ................................................................................................................................................................................................................................ 101

taiDoc.technology.Corporation.......................................................................................................................................101Blood Glucose Monitoring Systems ............................................................................................................................................101

TD-4227B .................................................................................................................................................................................................................................. 101TD-4227A .................................................................................................................................................................................................................................. 101TD-4225 ....................................................................................................................................................................................................................................102TD-4222, TD-4209 and TD-4207 .............................................................................................................................................................................................102

Blood Glucose and Pressure Monitoring Systems ..................................................................................................................102TD-3215 /TD-3216 ....................................................................................................................................................................................................................102TD-3217A ..................................................................................................................................................................................................................................102

TaiDoc PC-Link Software ...............................................................................................................................................................102TaiDoc Diabetes Management Software V2.2 ........................................................................................................................................................................102TaiDoc Health Management Software V2.2 ...........................................................................................................................................................................103

us.Diagnostics................................................................................................................................................................... 103

©espicom Business Intelligence ixJune 2006


Control Blood Glucose Monitoring System ...............................................................................................................................103EasyGluco G2 ..................................................................................................................................................................................104

EasyGluco Test Strips ............................................................................................................................................................................................................... 104GENERIC TEST STRIPS ........................................................................................................................................................... 105

incline.Medical....................................................................................................................................................................105Accurex Generic Test Strips ..........................................................................................................................................................105

invacare...............................................................................................................................................................................105Invacare AlternativeTest Strips ....................................................................................................................................................105

HbA1c TESTING ...................................................................................................................................................................... 106Axis-shield..........................................................................................................................................................................106

Afinion HbA1c Test .........................................................................................................................................................................106NycoCard HbA1c ............................................................................................................................................................................106

Bio-rad.laboratories..........................................................................................................................................................107Micromat II HbA1c Instrument .....................................................................................................................................................107

Bayer.healthcare................................................................................................................................................................107DCA 2000+ Analyser ......................................................................................................................................................................107

Cholestech...........................................................................................................................................................................108Cholestech GDX System ..............................................................................................................................................................108

Arkray..................................................................................................................................................................................108HA-8170 ............................................................................................................................................................................................108HA-8160 ............................................................................................................................................................................................108

Diabetes.technologies,.inc................................................................................................................................................108AccuBase A1c Test Kit .............................................................................................................................................................................................................. 108

Biosafe.................................................................................................................................................................................109HbA1c Test Kit ..................................................................................................................................................................................109FlexSite Laboratories .....................................................................................................................................................................109

Always 1n Control (A1C) ........................................................................................................................................................................................................... 109Metrika................................................................................................................................................................................109

A1cNow InView System .................................................................................................................................................................109Quotient.Diagnostics......................................................................................................................................................... 110

Other.eMerGinG.POC.teChnOlOGies................................................................................................... 111Molecular.vision................................................................................................................................................................. 111Medical.Prediction............................................................................................................................................................. 112

Female Fertility Monitor ............................................................................................................................................................... 112BioPreventive.ltd............................................................................................................................................................... 113

Theranostics .................................................................................................................................................................................... 113Point-of-Care Immunoassay Platform for Theranostic Use .................................................................................................. 113

Axis-shield.......................................................................................................................................................................... 114Axis-Shield and Theranostics ....................................................................................................................................................... 114

Theranostic Case Study: Axis-Shield DIATSTAT anti-CCP in Rheumatoid Arthritis .................................................................................................................114Agreements ..................................................................................................................................................................................... 115

ITI Techmedia (Biosensor Platform for Theranostic Applications) ..........................................................................................................................................115British.Biocell.international.............................................................................................................................................. 116

Contract Product Development - Theranostics ........................................................................................................................ 116Agreements ..................................................................................................................................................................................... 116

Merck ........................................................................................................................................................................................................................................116Inverness Medical Innovations .................................................................................................................................................................................................116

siemens.Medical.solutions................................................................................................................................................ 117QuickLab ......................................................................................................................................................................................... 117

POC.BlOOD.GAs/eleCtrOlYtes.MArKet................................................................................................118Bayer.Diagnostics............................................................................................................................................................... 118

©espicom Business Intelligence June 2006x


Blood Gas .........................................................................................................................................................................................118nova.Biomedical.................................................................................................................................................................118

Blood Gas Critical Care Analysers ................................................................................................................................................118Stat Profile Critical Care Xpress (CCX) ...................................................................................................................................................................................... 118Stat Profile pHOx Series ........................................................................................................................................................................................................... 118Nova 16: Whole Blood Chem 7 Plus Haematocrit for Point of Care ........................................................................................................................................ 118

Osmetech............................................................................................................................................................................119OPTI Analysers ................................................................................................................................................................................119

radiometer.........................................................................................................................................................................119Radiometer Blood Gas Analysers ................................................................................................................................................119

roche.Diagnostics..............................................................................................................................................................119COMPACT 3 ......................................................................................................................................................................................119cobas b 121 ......................................................................................................................................................................................119cobas b 221 .....................................................................................................................................................................................120

instrumentation.laboratory.(il).......................................................................................................................................120GEM Blood Gas Analysers .............................................................................................................................................................120

international.technidyne.Corporation............................................................................................................................120IRMA TRUpoint ...............................................................................................................................................................................120

Abbott.Diagnostics............................................................................................................................................................120i-STAT 1 .............................................................................................................................................................................................120

via.Medical..........................................................................................................................................................................121VIA Blood Gas and Chemistry Monitor .......................................................................................................................................121Via LVM Neonatal System .............................................................................................................................................................121

POC.CArDiOlOGY.DiAGnOstiCs.............................................................................................................. 122POC COAGULATION ANALYSERS ........................................................................................................................................ 122

roche.Diagnostics..............................................................................................................................................................123CaoguChek Coagulation Monitoring Systems ........................................................................................................................................................................123

hemosense.........................................................................................................................................................................123INRatio Prothrombin Time Monitoring System .....................................................................................................................................................................123

inverness.Medical.innovations.........................................................................................................................................123SmartCheck INR .............................................................................................................................................................................123

international.technidyne.Corporation.(itC)....................................................................................................................124Hemochron POC Coagulation Instruments ..............................................................................................................................124

Hemochron Signature Elite ..................................................................................................................................................................................................... 124Signature and Signature+ ...................................................................................................................................................................................................... 124Response .................................................................................................................................................................................................................................. 124ProTime Microcoagulation System ......................................................................................................................................................................................... 124

Coagulation – Comparison of Near Patient Testing Systems .............................................................................................................................................................125instrumentation.laboratory.............................................................................................................................................125

GEM PCL Plus Coagulation System ..........................................................................................................................................................................................125Farallon.Medical.................................................................................................................................................................125

Immedia PT System .................................................................................................................................................................................................................125Axis-shield...........................................................................................................................................................................125

Cephotest (APTT) .....................................................................................................................................................................................................................125Thrombotest (PT-INR) ..............................................................................................................................................................................................................125Nycotest PT (INR)...................................................................................................................................................................................................................... 126

vital.scientific.(Clinical.Data.inc).......................................................................................................................................126Vitalab Fibron 1 ....................................................................................................................................................................................................................... 126

POC.CArDiAC.MArKer.MArKet............................................................................................................... 127Biosite..................................................................................................................................................................................127

Triage MeterPlus ..................................................................................................................................................................................................................... 127

©espicom Business Intelligence xiJune 2006


bioMérieux..........................................................................................................................................................................129VIDAS D-Dimer Exclusion .........................................................................................................................................................................................................129

Dade.Behring......................................................................................................................................................................129Stratus CS Analyser ...................................................................................................................................................................................................................129

response.Biomedical.........................................................................................................................................................129RAMP Cardiac Marker System ..................................................................................................................................................................................................129

roche.Diagnostics..............................................................................................................................................................129Cardiac Reader ..........................................................................................................................................................................................................................129

Alfa.scientific......................................................................................................................................................................129Instant View Cardiac Marker Tests ...........................................................................................................................................................................................129

Troponin I (TnI) Whole Blood/Serum One Step Rapid Test ................................................................................................................................................................. 129inD.Diagnostics..................................................................................................................................................................130

One-Step Troponin-I Tests .......................................................................................................................................................................................................130One-Step Myoglobin Tests ........................................................................................................................................................................................................130

Mitsubishi.Kagaku.iatron.(MKi)........................................................................................................................................130Pathfast ....................................................................................................................................................................................................................................130

POC.PlAtelet.FunCtiOn.testinG...........................................................................................................131Platelet Function Analaysers ...............................................................................................................................................131

Dade.Behring......................................................................................................................................................................131PFA-100 .....................................................................................................................................................................................................................................131

Accumetrics.........................................................................................................................................................................131VerifyNow Rapid Platelet Function Test...................................................................................................................................................................................131VerifyNow P2Y12.......................................................................................................................................................................................................................131

sienco...................................................................................................................................................................................132Sonoclot Analyser .......................................................................................................................................................................... 132

POint-OF-CAre.CliniCAl.CheMistrY.AnAlYsers.................................................................................133Blood Chemistry Analysers ..................................................................................................................................................133

roche.Diagnostics..............................................................................................................................................................133Multi-parameter Clinical Chemistry Analysers ........................................................................................................................................................................133

Reflotron Plus and Refletron sprint .....................................................................................................................................................................................................133Abbott.................................................................................................................................................................................133

i-STAT CHEM 8+ Cartridge ........................................................................................................................................................................................................133Abaxis..................................................................................................................................................................................133

Piccolo........................................................................................................................................................................................................................................133Ortho-Clinical.Diagnostics................................................................................................................................................134

VITROS DT60 II Chemistry System ........................................................................................................................................................................................... 134horiba.ABX..........................................................................................................................................................................135

ABX Pentra 400 .........................................................................................................................................................................................................................135ABX Mira ....................................................................................................................................................................................................................................135

Urinalysis ................................................................................................................................................................................ 135roche.Diagnostics..............................................................................................................................................................135

Urisys 1100 Urine Analyser .......................................................................................................................................................................................................135Combur-Test Strips/Chemstrips ...............................................................................................................................................................................................135

Bayer.Diagnostics...............................................................................................................................................................136Clinitek Status Analyser ............................................................................................................................................................................................................136Clinitek 50 Urine Chemistry Analyser ......................................................................................................................................................................................136Clinitek 500 Urine Chemistry Analyser .....................................................................................................................................................................................136

Clinical.Data.inc.(vital.scientific).......................................................................................................................................136Microlab 300 .............................................................................................................................................................................................................................136Selectra Junior ...........................................................................................................................................................................................................................136

stanbio.laboratories.........................................................................................................................................................137

©espicom Business Intelligence June 2006xii


UriTrak 100 .............................................................................................................................................................................................................................. 137hypoguard..........................................................................................................................................................................137

DiaScreen 50 Urine Chemistry Analyser .................................................................................................................................................................................. 137iris.international.................................................................................................................................................................137

iChem100 Urine Chemistry Analyser ....................................................................................................................................................................................... 137Arkray..................................................................................................................................................................................138

PocketChem UA .............................................................................................................................................................................138Aution Eleven ..................................................................................................................................................................................138

POC.inFeCtiOus.DiseAse.test.MArKet................................................................................................. 139HIV Tests ................................................................................................................................................................................. 139

Comparison of POC HIV Tests .............................................................................................................................................................................................................139trinity.Biotech.................................................................................................................................................................... 140

Uni-Gold Recombigen HIV .......................................................................................................................................................................................................140Bio-rad............................................................................................................................................................................... 140

Multispot HIV-1/HIV-2 Rapid Test ............................................................................................................................................................................................140MedMira............................................................................................................................................................................. 140Orasure............................................................................................................................................................................... 140

OraQuick ADVANCE ..................................................................................................................................................................................................................140Chembio.Diagnostics.........................................................................................................................................................141

SURE CHECK HIV and HIV STAT-PAK ........................................................................................................................................................................................ 141inD.Diagnostics..................................................................................................................................................................141

One-Step Anti-HIV (1+2) Tests ................................................................................................................................................................................................ 141home.Access.health.Corporation.(hAhC)........................................................................................................................141

Home Access HIV-1 Test System .............................................................................................................................................................................................. 141biolytical.laboratories......................................................................................................................................................142

INSTI kit..................................................................................................................................................................................................................................... 142Hepatitis B and Hepatitis C Tests ........................................................................................................................................ 142

inD.Diagnostics..................................................................................................................................................................142One-Step Tests (Hepatitis B, Hepatitis C ) ................................................................................................................................................................................ 142

home.Access.health...........................................................................................................................................................142Hepatitis C Check Test .............................................................................................................................................................................................................. 142

MedMira..............................................................................................................................................................................142MiraWell Rapid HBV and HCV Tests ......................................................................................................................................................................................... 142

Orasure................................................................................................................................................................................143Rapid HCV test .......................................................................................................................................................................................................................... 143

Strep A Tests .......................................................................................................................................................................... 143Beckman.Coulter................................................................................................................................................................143

ICON SC Strep A......................................................................................................................................................................................................................... 143ICON DS Strep A ........................................................................................................................................................................................................................ 143

Becton.Dickinson.(BD)........................................................................................................................................................143BD Directigen EZ Strep A Test .................................................................................................................................................................................................. 143BD Chek Strep A Test ........................................................................................................................................................................................................... 143LINK2 Strep A CLIA-Waived Rapid Test Kit .............................................................................................................................................................................144

stanbio.laboratories........................................................................................................................................................ 144QuStick Strep A .........................................................................................................................................................................................................................144EZ-Well Strep A .........................................................................................................................................................................................................................144

Diagnostic.test.Group.(rAC.Medical).............................................................................................................................. 144Clarity Strep A ..........................................................................................................................................................................................................................144

instant.technologies......................................................................................................................................................... 144IStrep A-Rapid Test ..................................................................................................................................................................................................................144

Fisher.healthcare...............................................................................................................................................................145

©espicom Business Intelligence xiiiJune 2006


Fisher Sure-Vue Signature Strep A Test Kit ..............................................................................................................................................................................145Flu Tests .................................................................................................................................................................................. 145

BD.Diagnostics....................................................................................................................................................................145Directigen Flu A + B Test .........................................................................................................................................................................................................145Directigen Flu A Test ............................................................................................................................................................................................................145

Quidel..................................................................................................................................................................................145QuickVue Influenza ............................................................................................................................................................................................................................ 145QuickVue Influenza A+B test ............................................................................................................................................................................................................. 145

inverness.Medical...............................................................................................................................................................146NOW Flu A and NOW Flu B Tests .............................................................................................................................................................................................. 146BinaxNOW Influenza A & B Test .............................................................................................................................................................................................. 146

remel...................................................................................................................................................................................146Xpect Flu A&B Test ................................................................................................................................................................................................................... 146

Flu A & B Performance Comparison: Sensitivity and Specificity ......................................................................................................................................................... 146response.Biomedical.........................................................................................................................................................147

RAMP Flu A Test ........................................................................................................................................................................................................................147Respiratory Syncytial Virus .................................................................................................................................................147

BD.Diagnostics....................................................................................................................................................................147Directigen EZ RSV test .........................................................................................................................................................................................................147Directigen Respiratory Syncytial Virus (RSV) Test ..............................................................................................................................................................147

inverness.Medical...............................................................................................................................................................147Clearview RSV ..........................................................................................................................................................................................................................147NOW RSV Test ............................................................................................................................................................................................................................147BioStar OIA RSV ........................................................................................................................................................................................................................ 148

Meridian.Bioscience...........................................................................................................................................................148ImmunoCard STAT! RSV Plus ................................................................................................................................................................................................... 148

remel...................................................................................................................................................................................148Xpect RSV Test .......................................................................................................................................................................................................................... 148

trinity.Biotech.....................................................................................................................................................................148Uni-Gold RSV ........................................................................................................................................................................................................................... 148

sA.scientific.........................................................................................................................................................................148RSV Rapid Test .......................................................................................................................................................................................................................... 148

RSV Performance Comparison: Sensitivity and Specificity ................................................................................................................................................................. 149C.difficile Tests ....................................................................................................................................................................... 149

BD.Diagnostics....................................................................................................................................................................149ColorPacToxin A Test .................................................................................................................................................................................................................149

inverness.Medical...............................................................................................................................................................149BioStar OIA CdTOX A ..................................................................................................................................................................................................................149

Meridian.Bioscience...........................................................................................................................................................150ImmunoCard Toxins A&B ..........................................................................................................................................................................................................150

H. pylori .................................................................................................................................................................................. 150Beckman.Coulter................................................................................................................................................................150

FlexSure HP ...............................................................................................................................................................................................................................150BD.Diagnostics....................................................................................................................................................................150

LINK2 H. pylori Rapid Test .....................................................................................................................................................................................................150inverness.Medical...............................................................................................................................................................150

BioStar Acceava H. pylori ..........................................................................................................................................................................................................150Quidel..................................................................................................................................................................................150instant.technologies..........................................................................................................................................................151

iScreen H. Pylori .......................................................................................................................................................................................................................151Gi.supply.............................................................................................................................................................................151

©espicom Business Intelligence June 2006xiv


Hpfast ......................................................................................................................................................................................................................................151Provalis.Diagnostics.......................................................................................................................................................... 151

Helisal One Step .......................................................................................................................................................................................................................151MedMira............................................................................................................................................................................. 151

MiraWellhp Test .......................................................................................................................................................................................................................151Mononucleosis Tests ............................................................................................................................................................151

instant.technologies......................................................................................................................................................... 151iScreen Mono ...........................................................................................................................................................................................................................151

Fisher.healthcare.............................................................................................................................................................. 152Fisher Sure-Vue Signature Mono Test Kit ................................................................................................................................................................................152

Genzyme.Diagnostics....................................................................................................................................................... 152OSOM Mono .............................................................................................................................................................................................................................152

POC.DruGs-OF-ABuse.testinG............................................................................................................... 153Dade.Behring..................................................................................................................................................................... 153

Viva-Jr Drug Testing System ....................................................................................................................................................... 153ACOn.laboratories............................................................................................................................................................ 153

Drugs-of-Abuse Tests ................................................................................................................................................................... 153COT Cotinine One Step Test Device ......................................................................................................................................................................................... 154Saliva Alcohol Test Strips (DAL-701) ........................................................................................................................................................................................ 154

Alfa.scientific..................................................................................................................................................................... 154Instant-View Drug Screen Tests ............................................................................................................................................... 154

Bio-rad............................................................................................................................................................................... 154Drugs-of-abuse testing ................................................................................................................................................................ 154

TOX/See ................................................................................................................................................................................................................................... 154Biosite................................................................................................................................................................................. 154

Triage DOA Tests ............................................................................................................................................................................ 154Triage TOX Drug Screen with Acetaminophen ........................................................................................................................................................................155

Branan.Medical.................................................................................................................................................................. 155Oratect II Oral Fluid Drug Screen Device .................................................................................................................................. 155Urine product line ........................................................................................................................................................................ 155

ToxCup Drug Screen Cup .........................................................................................................................................................................................................155Monitect ...................................................................................................................................................................................................................................156QuickTox ...................................................................................................................................................................................................................................156Fastect II ...................................................................................................................................................................................................................................156

inD.Diagnostics................................................................................................................................................................. 156Drugs-of-abuse tests (MOP, COC, THC, MET, AMP).................................................................................................................. 156

instant.technologies......................................................................................................................................................... 156Drug Testing ................................................................................................................................................................................... 156

iScreen OFD ..............................................................................................................................................................................................................................156IScreen Oral .............................................................................................................................................................................................................................156Icup ...........................................................................................................................................................................................................................................157iScreen ODC ..............................................................................................................................................................................................................................157iScreen Cassette .......................................................................................................................................................................................................................157

Alcohol Screening ......................................................................................................................................................................... 157QED A150 ..................................................................................................................................................................................................................................157AlcoScreen Saliva Test Strip .....................................................................................................................................................................................................157BreathScan Alcohol Tests BS02, BS04, BS08 and BS10 ...........................................................................................................................................................157

Validity Screens and Adulteration ............................................................................................................................................. 157Orasure............................................................................................................................................................................... 157

Q.E.D. Saliva Alcohol Test ............................................................................................................................................................. 157Princeton.BioMeditech..................................................................................................................................................... 158

©espicom Business Intelligence xvJune 2006


AccuSign ..........................................................................................................................................................................................158wayPoint.Biomedical.........................................................................................................................................................158

Professional Tests ...........................................................................................................................................................................158Multi-Drug-9-Plus and Multi-Drug-11 ........................................................................................................................................158

OTC Tests ....................................................................................................................................................................................................................................158Health Essist COC-THC Home Drug Tests ..................................................................................................................................................................................158Health Essist Multi-Drug Cup....................................................................................................................................................................................................158

POC.tuMOur.MArKer.tests....................................................................................................................159FOB Testing ............................................................................................................................................................................ 159

Beckman.Coulter................................................................................................................................................................159Hemoccult ................................................................................................................................................................................................................................159

Aerscher.Diagnostics.........................................................................................................................................................159HemaPrompt & Hemaprompt FG ............................................................................................................................................................................................159

Quidel..................................................................................................................................................................................159QuickVue iFOB Test ....................................................................................................................................................................................................................159

Alfa.scientific......................................................................................................................................................................160Instant-View Faecal Occult Blood Test .................................................................................................................................................................................. 160

Diagnostic.test.Group.(rAC.Medical)...............................................................................................................................160Clarity Faecal Occult Test .......................................................................................................................................................................................................... 160

instant.technologies..........................................................................................................................................................160iScreen FOB............................................................................................................................................................................................................................... 160

Orion.Diagnostica...............................................................................................................................................................160QuikRead FOB .......................................................................................................................................................................................................................... 160

CAre.Products,.inc.............................................................................................................................................................161ImmoCARE FOB Test .................................................................................................................................................................................................................161hemoCARE FOB Test ..................................................................................................................................................................................................................161ColonCARE FOB Test ..................................................................................................................................................................................................................161

Biomerica............................................................................................................................................................................161EZ Detect FOB Test ....................................................................................................................................................................................................................161

PSA and Other Tumour Marker Tests ................................................................................................................................ 162inD.Diagnostics..................................................................................................................................................................162

One-Step Tumour Marker Tests ...............................................................................................................................................................................................162Alfa.scientific......................................................................................................................................................................162

Instant-View PSA Serum Test ...................................................................................................................................................................................................162ACOn.laboratories.............................................................................................................................................................162

Tumour Marker Tests ................................................................................................................................................................................................................162AFP Rapid Test Device (Whole Blood/Serum/Plasma) ....................................................................................................................................................................... 163

Biomerica............................................................................................................................................................................163EZ-PSA .......................................................................................................................................................................................................................................163

Matritech.............................................................................................................................................................................163NMP22 BladderChek Test .........................................................................................................................................................................................................163

POC.PreGnAnCY/FertilitY.MArKet.......................................................................................................164Global Pregnancy and Fertility Market, 2005 (US$630 million Consumer Market(CAGR = 5%)) ..................................................................................................... 164 ........................................................................................................................................................................................................................................................... 164

Pregnancy Tests ................................................................................................................................................................... 165inverness.Medical...............................................................................................................................................................165

Clearblue .................................................................................................................................................................................................................................. 165Rapid Membrane Test Products .............................................................................................................................................................................................. 165

Beckman.Coulter................................................................................................................................................................165ICON 25 hCG .............................................................................................................................................................................................................................. 166ICON II HCG ................................................................................................................................................................................................................................ 166

©espicom Business Intelligence June 2006xvi


Genzyme.Diagnostics....................................................................................................................................................... 166OSOM Card Pregnancy ............................................................................................................................................................................................................166

inD.Diagnostics................................................................................................................................................................. 166Early Home Pregnancy Test ....................................................................................................................................................................................................166One-Step hCG Urine Pregnancy Tests ......................................................................................................................................................................................167One-Step Combo hCG Pregnancy Tests ..................................................................................................................................................................................167One-Step Semi-Quantitative hCG Pregnancy Tests ...............................................................................................................................................................167

Alfa.scientific......................................................................................................................................................................167Instant-View Fertility Tests ...................................................................................................................................................................................................167

Diagnostic.test.Group.(rAC.Medical)...............................................................................................................................167Clarity hCG Strips and Cassettes ..............................................................................................................................................................................................167

instant.technologies......................................................................................................................................................... 168iPregnancy Test ........................................................................................................................................................................................................................168

Church.&.Dwight................................................................................................................................................................ 168FIRST RESPONSE Early Result Pregnancy Test .........................................................................................................................................................................168FIRST RESPONSE Easy-Read Ovulation Predictor Test ...........................................................................................................................................................168Answer Pregnancy and Ovulation Tests .................................................................................................................................................................................168

rohto.Pharmaceutical....................................................................................................................................................... 168Dotest hCG Plus Pregnancy Test Kit .........................................................................................................................................................................................169

Omega.Pharma.................................................................................................................................................................. 169Predictor ...................................................................................................................................................................................................................................169

Quidel................................................................................................................................................................................. 169Professional Pregnancy Tests ..................................................................................................................................................................................................169

QuickVue One-Step hCG Combo .........................................................................................................................................................................................................169QuickVue One-Step hCG Urine ............................................................................................................................................................................................................169QuickVue Semi-Q hCG Combo ............................................................................................................................................................................................................169RapidVue hCG .....................................................................................................................................................................................................................................170

POint-OF-CAre.DAtA.MAnAGeMent..................................................................................................... 171Medical.Automation.systems...........................................................................................................................................171

RALS-Plus ........................................................................................................................................................................................171RALS eQuiz ......................................................................................................................................................................................171RALS-TGCM ......................................................................................................................................................................................172RALS-Report ....................................................................................................................................................................................172

Abbott.Diagnostics............................................................................................................................................................172QC Manager ....................................................................................................................................................................................172Precision Net - Abbott Diagnostics (FDA approved) ...............................................................................................................172

instrumentation.laboratory.............................................................................................................................................173Information Management ............................................................................................................................................................173Integrated HIS/LIS Connection ...........................................................................................................................................................................................................173Meets Regulatory Requirements .......................................................................................................................................................................................................173Comprehensive Reports .....................................................................................................................................................................................................................173Analyser Data Capture .......................................................................................................................................................................................................................173Intuitive .............................................................................................................................................................................................................................................173Platform ............................................................................................................................................................................................................................................ 174

IMPACT Report Writer .............................................................................................................................................................................................................. 174Bayer.Diagnostics...............................................................................................................................................................174

Rapidlink Critical Care Information Management System ..................................................................................................................................................... 174RapidComm ............................................................................................................................................................................................................................. 174

nova.Biomedical.................................................................................................................................................................175Patient Data Manager (PDM) N/A ........................................................................................................................................................................................... 175

lifescan...............................................................................................................................................................................175

©espicom Business Intelligence xviiJune 2006

Point of care Diagnostics

TablESLeading Manufacturers’ Diabetes Care Revenues 2004-2005 (US$ million) .......................................................................................................................................11Coagulation – Comparison of Near Patient Testing Systems .............................................................................................................................................................125Comparison of POC HIV Tests .............................................................................................................................................................................................................139Flu A & B Performance Comparison: Sensitivity and Specificity .........................................................................................................................................................146RSV Performance Comparison: Sensitivity and Specificity .................................................................................................................................................................149

CharTSPOCT Relative to the Global In Vitro Diagnostics Market, 2005 ................................................................................................1Global POCT Market by Region, 2005 (Global Market = US$10.6 billion) ................................................................................3European* POCT Market by Region, 2005 (Market = US$3.0 billion) .......................................................................................4Blood Glucose Monitoring Market Leaders, 2004/2005 ...........................................................................................................10Global Pregnancy and Fertility Market, 2005 (US$630 million Consumer Market(CAGR = 5%)) ................................... 164

table of contents

DataLink Data Management System ......................................................................................................................................................................................175Point of Care Diagnostics ..............................................................................................................................................................176

Datalink.Connectivity.solutions......................................................................................................................................176DataLink Connect ...........................................................................................................................................................................176

DataLink Control ......................................................................................................................................................................................................................176DataLink Interface/ISI Software ..............................................................................................................................................................................................176

Optional DataLink Modules .........................................................................................................................................................176DataLink with RALS-Plus .........................................................................................................................................................................................................176DataLink with QML ..................................................................................................................................................................................................................177

Menarini.Diagnostics........................................................................................................................................................ 177POC Data Management ................................................................................................................................................................177

Documents

The Global Market for Point of Care Diagnostics - … · The Global Market for Point of Care Diagnostics: ... CK-MB Cardiac Marker Test ... The Global Market for Point of Care Diagnostics: