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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 1
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture
Reference Code: GDME0193RDB
Publication Date: December 2012
SAMPLE
Table of Contents
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 2
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 33
1.2 List of Figures 42
2 Introduction 43
2.1 What is This Report About? 43
3 In Vitro Diagnostics in North America 44
3.1 In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018 44
3.2 In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018 45
3.3 In Vitro Diagnostics, North America, Company share (2010-2011) 53
4 In Vitro Diagnostics In United States 55
4.1 In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 55
4.2 In Vitro Diagnostics, United States, Distribution Share (2010-2011) 61
4.2.1 Clinical Chemistry Distribution Share (2010-2011) 61
4.2.2 Genetic Testing Distribution Share (2010-2011) 61
4.2.3 Haematology Distribution Share (2010-2011) 62
4.2.4 Histology And Cytology Distribution Share (2010-2011) 62
4.2.5 Immuno Chemistry Distribution Share (2010-2011) 63
4.2.6 Infectious Immunology Distribution Share (2010-2011) 63
4.2.7 Microbiology Culture Distribution Share (2010-2011) 64
4.3 In Vitro Diagnostics, United States, Company Share (2010-2011) 65
4.3.1 Clinical Chemistry, United States, Company Share (2010-2011) 67
4.3.2 Genetic Testing, United States, Company Share (2010-2011) 68
4.3.3 Haematology, United States, Company Share (2010-2011) 70
4.3.4 Immuno Chemistry, United States, Company Share (2010-2011) 72
4.3.5 Infectious Immunology, United States, Company Share (2010-2011) 74
4.3.6 Microbiology Culture, United States, Company Share (2010-2011) 76
5 In Vitro Diagnostics In Canada 78
SAMPLE
Table of Contents
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 3
5.1 In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, 2004-2018 78
5.2 In Vitro Diagnostics, Canada, Distribution Share (2010-2011) 84
5.3 Clinical Chemistry Distribution Share (2010-2011) 84
5.3.1 Genetic Testing Distribution Share (2010-2011) 84
5.3.2 Haematology Distribution Share (2010-2011) 85
5.3.3 Histology And Cytology Distribution Share (2010-2011) 85
5.3.4 Immuno Chemistry Distribution Share (2010-2011) 86
5.3.5 Infectious Immunology Distribution Share (2010-2011) 86
5.3.6 Microbiology Culture Distribution Share (2010-2011) 87
5.4 In Vitro Diagnostics, Canada, Company Share (2010-2011) 88
5.4.1 Clinical Chemistry, Canada, Company Share (2010-2011) 90
5.4.2 Genetic Testing, Canada, Company Share (2010-2011) 92
5.4.3 Haematology, Canada, Company Share (2010-2011) 94
5.4.4 Histology And Cytology, Canada, Company Share (2010-2011) 96
5.4.5 Immuno Chemistry, Canada, Company Share (2010-2011) 98
5.4.6 Infectious Immunology, Canada, Company Share (2010-2011) 100
5.5 Microbiology Culture, Canada, Company Share (2010-2011) 102
6 Overview of Key Companies in North America In Vitro Diagnostics 104
6.1 Siemens Healthcare 104
6.1.1 Company Overview 104
6.1.2 Share in the North America In Vitro Diagnostics Market 104
6.2 Abbott Laboratories 105
6.2.1 Company Overview 105
6.2.2 Share in the North America In Vitro Diagnostics Market 105
6.3 F. Hoffmann-La Roche Ltd. 106
6.3.1 Company Overview 106
6.3.2 Share in the North America In Vitro Diagnostics Market 106
6.4 Beckman Coulter, Inc. 107
6.4.1 Company Overview 107
6.4.2 Share in the North America In Vitro Diagnostics Market 107
6.5 Ortho-Clinical Diagnostics Inc. 108
6.5.1 Company Overview 108
6.5.2 Share in the North America In Vitro Diagnostics Market 108
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Table of Contents
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 4
6.6 Alere Inc. 109
6.6.1 Company Overview 109
6.6.2 Share in the North America In Vitro Diagnostics Market 109
6.7 bioMerieux S.A. 110
6.7.1 Company Overview 110
6.8 Becton, Dickinson and Company 110
6.8.1 Company Overview 110
6.9 Bio-Rad Laboratories, Inc. 111
6.9.1 Company Overview 111
6.10 Sysmex Corporation 111
6.10.1 Company Overview 111
6.11 Qiagen N.V. 112
6.11.1 Company Overview 112
6.12 Gen-Probe Incorporated 112
6.12.1 Company Overview 112
6.13 DiaSorin S.p.A 113
6.13.1 Company Overview 113
6.14 Immucor, Inc. 113
6.14.1 Company Overview 113
6.15 Thermo Fisher Scientific Inc. 114
6.15.1 Company Overview 114
6.16 Hologic, Inc. 114
6.16.1 Company Overview 114
6.17 Cepheid 115
6.17.1 Company Overview 115
6.18 PerkinElmer, Inc. 115
6.18.1 Company Overview 115
6.19 Grifols, S.A. 116
6.19.1 Company Overview 116
6.20 ELITech Group 116
6.20.1 Company Overview 116
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Table of Contents
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 5
6.21 Life Technologies Corporation 117
6.21.1 Company Overview 117
6.22 Horiba, Ltd. 117
6.22.1 Company Overview 117
6.23 Biomedica Diagnostics Inc. 118
6.23.1 Company Overview 118
6.24 Diagnostica Stago, Inc. 118
6.24.1 Company Overview 118
6.25 OraSure Technologies, Inc. 118
6.25.1 Company Overview 118
7 North America Market Pipeline Products 119
7.1 Clinical Chemisty Market Pipeline Products 119
7.2 Immuno Chemistry Market Pipeline Products 126
7.3 Haematology Market Pipeline Products 137
7.4 Infectious Immunology Market Pipeline Products 139
7.5 Microbiology Culture Market Pipeline Products 146
7.6 Histology And Cytology Market Pipeline Products 148
7.7 Genetic Testing Market Pipeline Products 149
8 Financial Deals Landscape 154
8.1 Acquisition 154
8.1.1 SQI Diagnostics Plans For Sale Of The Company 154
8.1.2 Sparton Completes Acquisition Of Onyx EMS, Contract Manufacturing Services Provider, For $43
Million 155
8.1.3 ERBA Diagnostics Acquires Drew Scientific, Maker Of Analytical Instruments And Reagents, For
$6.5 Million 157
8.1.4 Measurement Specialties Acquires Cambridge Technologies And Resistance Temperature
Detector Company For $18.8 Million 159
8.1.5 Atossa Genetics Acquires Acueity Healthcare, Diagnostic Device Provider 160
8.1.6 AccelPath Acquires DigiPath Solutions For $2.4 Million 161
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 6
8.1.7 Danaher Completes Acquisition Of 91.6% Stake In Iris International, Diagnostic Test Maker, For
$324 Million 162
8.1.8 Charles River Labs Acquires Accugenix, Provider Of Microbe Identification Services, For $17
Million 164
8.1.9 Leica Biosystems Completes Acquisition Of Aperio Technologies 166
8.1.10 Metabolon Acquires Lipomics Technologies, Diagnostics Company 169
8.1.11 Waters Acquires Blue Reference, Maker Of Application Scientific Databases, For $14 Million 171
8.1.12 Life Technologies Acquires Pinpoint Genomics, Molecular Diagnostics Company 172
8.1.13 Thermo Fisher Scientific Completes Acquisition Of One Lambda, Transplant Diagnostics
Company, For $925 Million 173
8.1.14 Life Technologies Acquires Navigenics 175
8.1.15 Genova Diagnostics Acquires Metametrix, Clinical Laboratory 177
8.1.16 23andMe Acquires CureTogether, Healthcare IT Company 178
8.1.17 Luminex To Acquire GenturaDx, Molecular Diagnostics Company, For $50 Million 179
8.1.18 Systagenix Acquires O2 Insights 181
8.1.19 Maxxam Analytics Acquires Becquerel Labs, Provider Of Testing Services 182
8.1.20 LabCorp Completes Acquisition Of Medtox Scientific For $241 Million 183
8.1.21 Flagship Biosciences Acquires Ihctech, Provider Of Research Immunohistochemistry And
Histology Services 185
8.1.22 Halo Healthcare Acquires NeoMatrix, Maker Of Diagnostic Equipments 186
8.1.23 Pacepartners To Acquire Vivione BioSciences 187
8.1.24 Qiagen Acquires AmniSure International, Manufacturer Of Non Invasive Test Solutions 188
8.1.25 Hologic Completes Acquisition Of Gen-Probe For $3.7 Billion 189
8.1.26 Haemonetics To Acquire Hemerus Medical, Provider Of Leukoreduction Technologies, For $27
Million 192
8.1.27 IntegenX Acquires SV, Provider Of DNA Identification Consumable Products, From GE
Healthcare Bio-Sciences 194
8.1.28 Beckman Coulter Acquires Blue Ocean Biomedical From Npe Systems 195
8.1.29 Abcam Completes Acquisition Of Epitomics, Rabbit Monoclonal Antibodies Provider, For $155
Million 196
8.1.30 Ontario Genomics Institute Acquires Minority Stake In RNA Diagnostics For $0.1 Million 198
8.1.31 PhotoVoltaic Solar Cells Acquires MetaStat, Life Science Company 199
8.1.32 Alere To Acquire eScreen, Provider Of Health Testing Products And Services, For Up To $340
Million 200
8.1.33 Bode Technology Group Acquires Provider Of DNA Analysis Testing Services, Chromosomal
Labs 202
8.1.34 Signal Genetics To Acquire Molecular Diagnostics Company, ChipDX 203
8.2 Partnerships 204
8.2.1 Multiple Myeloma Research Foundation Enters Into Co-Development Agreement With
GenoSpace 204
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 7
8.2.2 Empire Genomics Enters Into Licensing Agreement With Emory University For Genomic
Biomarkers 205
8.2.3 NanoPass Technologies Enters Into Licensing Agreement With Janssen Pharma For MicronJet
206
8.2.4 Cisbio Bioassays Enters Into Distribution Agreement With BellBrook Labs For Transcreener
Epigen Methyltransferase Assay 207
8.2.5 BioView Enters Into Agreement With Abbott To Develop Automated Cancer Screening System
209
8.2.6 Institute of Microelectronics Enters Into Co-Development Agreement With SFC Fluidics 210
8.2.7 HTG Molecular Diagnostics Enters Into Licensing Agreement With Centre of Excellence for
Prevention of Organ Failure For COPD Prognostic Test 211
8.2.8 Pressure BioSciences Enters Into Co-Marketing Agreement With Constant Systems For High
Pressure Technologies 212
8.2.9 CML HealthCare Enters Into Licensing Agreement With Mitomics For Prostate Cancer Test 214
8.2.10 bioMerieux Enters Into Licensing Agreement With Quanterix For Simoa Technology 215
8.2.11 DioGenix Enters Into Agreement With Fast Forward To Develop New Blood Test For Multiple
Sclerosis 217
8.2.12 GNS Healthcare Enters Into Agreement With Dana-Farber Cancer Institute and Mount Sinai
School of Medicine 219
8.2.13 Crown Bioscience Enters Into Co-Development Agreement With Horizon Discovery 221
8.2.14 CombiMatrix Enters Into Co-Marketing Agreement With Pathology For Prenatal Tests 222
8.2.15 Clinical Genomics Enters Into Licensing Agreement With Quest Diagnostics For Colon Cancer
Markers 223
8.2.16 Abaxis Enters Into Distribution Agreement With Abbott Point of Care For Piccolo Blood Chemistry
System 224
8.2.17 Affinity Biosensors Enters Into Distribution Agreement With Malvern Instruments For Archimedes
Particle Metrology System 226
8.2.18 Malvern Instruments Enters Into Co-Marketing Agreement With Affinity Biosensors For
Archimedes Particle Metrology System 227
8.2.19 Exosome Diagnostics Enters Into Co-Development Agreement With Promega For Urine Clinical
Sample Concentrator Kit 228
8.2.20 Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ 229
8.2.21 Ezose Enters Into Co-Development Agreement With Fast Forward For Multiple Sclerosis
Biomarkers 230
8.2.22 BioDot Enters Into Co-Marketing Agreement With JOT Automation 231
8.2.23 Sequella Enters Into Licensing Agreement With LabCorp For B-Smart Technology 232
8.2.24 LifeTech Scientific, DiNova Venture Partners, Themes Investment Partners And Broncus
Technologies Partner To Form Broncus Medical 233
8.2.25 Van Andel Institute Enters Into Co-Development Agreement With Emory University 235
8.2.26 Merck Serono Enters Into Co-Development Agreement With Auxogyn For Early Embryo Viability
Assessment Test 236
8.2.27 PGXL Labs Enters Into Joint Venture Agreement With Essential Molecular Testing 237
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 8
8.2.28 Broad Institute Enters Into Distribution Agreement With Appistry For Genome Analysis Toolkit 238
8.2.29 Thermo Fisher Enters Into Co-Development Agreement With Immundiagnostik 239
8.2.30 Sage Labs Enters Into Agreement With Ekam Imaging To Develop Imaging Assays 240
8.2.31 Bruker Enters Into An Agreement With Nextval For High-throughput Screening Technology 241
8.2.32 BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays
242
8.2.33 RainDance Technologies Enters Into Co-Development Agreement With Integrated DNA
Technologies For Digital PCR 243
8.2.34 Amarantus BioSciences Enters Into Option For Licensing Agreement With Memory Dx For
LymPro Blood Test 245
8.2.35 Iverson Genetic Diagnostics Enters Into Licensing Agreement With Johns Hopkins University
School For Molecular Diagnostic Tests 246
8.2.36 Rosetta Genomics Amends Co-Marketing Agreement With Precision Therapeutics For miRview
mets2 Assays 247
8.2.37 Mitomics Enters Into Co-Marketing Agreement With LabCorp For Prostate Core Mitomic Test 248
8.2.38 Trillium Diagnostics Enters Into Licensing Agreement With Leukocare For Sepsis Dx 250
8.2.39 Foundation Medicine Enters Into Agreement With Eisai For Genomic Profiling And Diagnostic
Discovery 251
8.2.40 Vela Diagnostics Enters Into Licensing Agreement With Life Technologies 252
8.2.41 Augurex Life Sciences Enters Into Licensing Agreement With Quest Diagnostics For 14-3-3n
Biomarker 253
8.2.42 CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital Microscopy
Hematology Solutions 254
8.2.43 Ingenuity Systems Enters Into Co-Development Agreement With Life Technologies For
Diagnostic Solutions 256
8.2.44 Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx
Test 258
8.2.45 Genia Technologies Enters Into Co-Development Agreement With Columbia University And
Harvard University 260
8.2.46 NextBio Enters Into Agreement With Winship Cancer Institute of Emory University For Myeloma
Biomarkers 262
8.2.47 Proof Centre Enters Into Co-Development Agreement With AllerGen For Allergy Biomarkers 263
8.2.48 Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology 264
8.2.49 Atossa Enters Into Co-Marketing Agreement With Diagnostics Test Group For MASCT System
265
8.2.50 Genalyte Partners Scienion To Provide Sciflexarrayer Dispensers For Maverick Detection
Platform 266
8.2.51 CML HealthCare Enters Into Agreement With MaRS Innovation 267
8.2.52 Life Technologies Enters Into Agreement With Bristol-Myers Squibb For Companion Diagnostics
Development 268
8.2.53 Agilent Technologies Enters Into Co-Marketing Agreement With Molecular Discovery 269
8.2.54 Agilent Technologies Enters Into Co-Marketing Agreement With MRM Proteomics 270
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 9
8.2.55 Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For
Mesothelioma Test 271
8.2.56 Illumina Enters Into Technology Integration Agreement With Partners HealthCare System 272
8.2.57 Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array
Products 274
8.2.58 ImaginAb Enters Into Co-Development Agreement With MacroGenics 275
8.2.59 BellBrook Labs Enters Into Co-Development Agreement With Reaction Biology 276
8.2.60 GVK Biosciences Enters Into Licensing Agreement With National Cancer Institute For GOBIOM
Database 277
8.2.61 GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina 278
8.2.62 Perkinelmer Enters Into Co-Development Agreement With Massachusetts General Hospital 279
8.2.63 Affymetrix Enters Into Co-Development Agreement With Pathgen Dx 281
8.2.64 Axela Enters Into Co-Marketing Agreement With OvaGene Oncology 282
8.2.65 University of Michigan Enters Into Joint Venture Agreement With International Genomics
Consortium 283
8.2.66 Regulus Therapeutics Enters Into An Agreement With Biogen Idec For Biomarkers 284
8.2.67 Curetis Enters Into Licensing Agreement With Cempra For Unyvero 285
8.2.68 Foundation Medicine Enters Into Co-Development Agreement With Clovis Oncology 286
8.2.69 Saladax Biomedical Expands Co-Development Agreement With Bristol-Myers Squibb 287
8.2.70 Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test
288
8.2.71 Waters Enters Into Co-Development Agreement With Nonlinear Dynamics 289
8.2.72 Affymetrix Expands Licensing Agreement With Siemens Healthcare For Branched DNA
Technology 290
8.2.73 Molecular Targeting Technologies Enters Into Licensing Agreement With Medical College of
Wisconsin For 99mTc-HYNIC-Duramycin 291
8.2.74 Rosetta Genomics Enters Into Co-Marketing Agreement With Precision Therapeutics For
miRview mets2 Assays 292
8.2.75 Bio-Rad Labs Enters Into Distribution Agreement With Myriad RBM For Multiplex Biomarker Kits
294
8.2.76 Gen-Probe Enters Into Co-Marketing Agreement With Life Technologies 295
8.2.77 OriGene Technologies Enters Into Co-Development Agreement With Centre of Excellence for
Prevention of Organ Failure 296
8.2.78 Siemens Healthcare Diagnostics Enters Into Distribution Agreement With Sysmex 297
8.2.79 IRIS International Enters Into Distribution Agreement With Alifax 298
8.2.80 EKF Diagnostics Enters Into Licensing Agreement With Joslin Diabetes Center 299
8.2.81 SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor 301
8.2.82 Clovis Oncology Enters Into Co-Development Agreement With Array BioPharma 302
8.2.83 RS Medical Enters Into Distribution Agreement With Harvest Technologies 303
8.2.84 Immuno-Biological Labs Enters Into Licensing Agreement With IBL International 304
8.2.85 Sandia National Labs Plans To Enter Into Licensing Agreement For SpinDx, Medical Diagnostic
Tool 305
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 10
8.2.86 HTG Molecular Diagnostics Enters Into Licensing Agreement With Merck For Breast Cancer
Marker Patent Portfolio 306
8.2.87 Genisphere Enters Into Co-Development Agreement With Lankenau Institute for Medical
Research 307
8.2.88 WaferGen Biosystems Enters Into Agreement With Integrated DNA Technologies 308
8.2.89 Pacgen Enters Into Distribution Agreement With Arise Biotech For Pipettes 309
8.2.90 BioView Enters Into Co-Development Agreement With ScreenCell For Circulating Tumor Cell
Analysis Technology 310
8.2.91 MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test 311
8.2.92 Fluxion Biosciences Enters Into Co-Development Agreement With Stanford University School of
Medicine 313
8.2.93 Merrimack Pharma Enters Into Co-Development Agreement With Cancer Treatment Centers of
America 314
8.2.94 Phenomenome Discoveries Enters Into Licensing Agreement With Polymedco For Cancer
Diagnostic Test 315
8.2.95 PlexPress Enters Into Technology Integration Agreement With Phalanx Biotech 316
8.2.96 PrimeraDx Enters Into Co-Development Agreement With Eli Lilly 317
8.2.97 Kreatech Diagnostics Enters Into Co-Development Agreement With Oridis Biomarkers For DNA-
FISH Assays 319
8.2.98 Stratos Enters Into Co- Development Agreement With nanoMR 320
8.2.99 Guided Therapeutics Extends Licensing And Co-Development Agreement With Konica Minolta
321
8.2.100 CogState Enters Into Licensing Agreement With Merck Canada For Cognition Test 322
8.2.101 Berg Pharma Enters Into Co-Development Agreement With Parkinson's Institute 323
8.2.102 Courtagen Life Sciences Enters Into Licensing Agreement With Scienion For sciFlexArrayer
Technology 324
8.2.103 NicOx Enters Into Licensing Agreement With Rapid Pathogen Screening For AdenoPlus 325
8.2.104 Leica Microsystems Enters Into Integration Agreement With Indica Labs 327
8.2.105 Prolias Technologies Enters Into Licensing Agreement With Cornell University For microRNA
Diagnostic Portfolio 328
8.2.106 Epigenomics Enters Into Licensing Agreement With Companion Dx Reference Lab For Septin9
Biomaker 329
8.2.107 Immunexpress Enters Into Licensing Agreement With Debiopharm And Biocartis 330
8.2.108 Asuragen Enters Into Licensing Agreement With Becton, Dickinson 332
8.2.109 Omega Diagnostics Enters Into Licensing Agreement With Burnet Institute For CD4 POC Test
333
8.2.110 KineMed Enters Into Co-Development Agreement With GlaxoSmithKline 334
8.2.111 Bruker Enters Into Research Agreement With Special Bacteriology Reference Laboratory 335
8.2.112 Bruker Enters Into Research Agreement With JMI Laboratories 337
8.2.113 RayBiotech Enters Into Agreement With Oslo University Hospital And University of Oslo 338
8.2.114 Vela Diagnostics Enters Into Co-Development Agreement With Eppendorf 340
8.2.115 One Lambda Enters Into Co-Marketing Agreement With CellTrend 341
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 11
8.2.116 ImaginAb Extends Licensing Agreement With Bzl Biologics For Imaging Prostate Specific
Membrane Antigen 342
8.2.117 Foundation Medicine Extends Co-Development Agreement With Novartis 343
8.2.118 Affymetrix Enters Into Co-Development Agreement With Massachusetts General Hospital For
New Oncology Biomarker Tests 344
8.2.119 Fluxion Bioscience Enters Into Technology Integration Agreement With Rubicon Genomics 345
8.2.120 Exosome Diagnostics Enters Into Technology Integration Agreement With Life Technologies
346
8.2.121 HTG Molecular Diagnostics Enters Into Co-Marketing Agreement With John Wayne Cancer
Institute 347
8.2.122 Clarient Diagnostic Services Enters Into Licensing Agreement With Insight Genetics For ALK
Cancer Biomarker 348
8.2.123 Ventana Medical Enters Into Licensing Agreement With German Cancer Research Center And
University Hospital Heidelberg For BRAF V600E 349
8.2.124 Affymetrix Enters Into Technology Integration Agreement With Leica Microsystems 351
8.2.125 Radisens Diagnostics Enters Into Co-Development Agreement With Beckman Coulter For HDR
Detection Technology 353
8.2.126 XDx Enters Into Agreement With LabCorp To Develop Lupus Flare Predictor Test 354
8.2.127 Prosolia Enters Into Licensing Agreement With AB Sciex For ORNL Analytical Technology 356
8.2.128 Ventana Medical Enters Into Licensing Agreement With Gen-Probe For IP Of ERG Marker 357
8.2.129 Affymetrix Enters Into Distribution Agreement With ScreenCell For Circulating Tumor Cell
Technology 359
8.2.130 Exact Sciences Expands Licensing Agreement With Mayo Clinic 360
8.2.131 Hycor Biomedical Enters Into Distribution Agreement With Roche For KOVA 361
8.2.132 Dako Announces Licensing Agreement With Van Andel Research Institute For Cancer
Diagnostic Tool 362
8.2.133 MicroFluidic Systems Enters Into Co-Development Agreement With University of Nevada 363
8.2.134 KineMed Enters Into Co-Development Agreement With CHDI Foundation 364
8.2.135 ZyGem Enters Into Technology Integration Agreement With Quanta BioSciences 365
8.2.136 Pressure BioSciences Enters Into Co-Development Agreement With Leap Technologies, Vici
Valco Instruments And Sage-N Research 366
8.2.137 Islet Sciences Enters Into Licensing Agreement With Yale University For Early Beta Cell
Destruction and Diabetes Diagnostic 368
8.2.138 Genomic Health Enters Into Co-Development Agreement With OncoMed Pharma 369
8.2.139 Applied Microarrays Enters Into Co-Development Agreement With Sensovation For FlexiPlex
Array System 370
8.2.140 Cardinal Health Enters Into Distribution Agreement With Qiagen For Molecular Diagnostic
Products 371
8.2.141 MetaStat Enters Into Licensing Agreement With Albert Einstein College of Medicine For
Metastatic Cell Technology Patents 372
8.2.142 Genome Diagnostics Enters Into Co-Marketing Agreement With Qiagen For LongRange PCR
Kit 373
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 12
8.2.143 Biofortuna Extends Co-Marketing Agreement With Abbott Labs For SSPGo 374
8.2.144 Pressure BioSciences Enters Into Licensing Agreement With Target Discovery For Pressure
Cycling Technology 375
8.2.145 Ezose Sciences Enters Into Co-Development Agreement With Hirosaki University For New
Cancer Biomarkers 377
8.2.146 LipoScience Enters Into Licensing Agreement With Cleveland Clinic 378
8.2.147 GE Healthcare Enters Into Co-Development Agreement With NXT2B For Compact Cyclotron
And PET Tracer System 379
8.2.148 Miraculins Enters Into Co-Marketing Agreement With Pear Healthcare Solutions For PreVu 380
8.2.149 Abbott Enters Into Licensing Agreement With Stanford University For Prostate Cancer
Biomarkers 381
8.2.150 Metabolon Enters Into Co-Development Agreement With Takeda Pharma 383
8.2.151 Penn State Hershey Enters Into Co-Development Agreement With Serametrix 384
8.2.152 Sysmex Extends Distribution Agreement With Roche 385
8.2.153 Seattle Genetics And Millennium Pharma Enter Into Co-Development Agreement With Ventana
Medical Systems 387
8.2.154 Rubicon Genomics Enters Into Technology Integration Agreement With Kreatech Diagnostics
389
8.2.155 NexDx Enters Into Licensing Agreement With University of California For Epigenetic
Biomarkers 390
8.2.156 Elchrom Scientific Enters Into Technology Integration Agreement With Biotium 391
8.2.157 RayBiotech Enters Into Co-Marketing Agreement With Innopsys 392
8.2.158 BGN Technologies Enters Into Licensing Agreement With Lauren Sciences For V-Smart
Technology 393
8.2.159 Stellar Biotechnologies Enters Into Option Licensing Agreement With University of Guelph For
Clostridium Difficile Technology 394
8.2.160 Shimadzu Scientific Instruments Enters Into Joint Venture Agreement With University of Texas
395
8.2.161 Centre of Excellence for Prevention of Organ Failure Enters Into Co-Development Agreement
With Adiga Life Sciences For Proteomic And Genomic Biomarkers 396
8.2.162 Ridge Diagnostics Enters Into Licensing Agreement With Ameritox For MDDScore 397
8.2.163 Bio-Rad Labs Extends Distribution Agreement With Luminex For MAGPIX 398
8.2.164 LabCorp Enters Into Licensing Agreement With OPKO Health For Alzheimer's Diagnostic
Technology 400
8.2.165 Accuray Enters Into Co-Development Agreement With University of Heidelberg 402
8.2.166 HTG Molecular Diagnostics Enters Into Co-Development Agreement With sanofi-aventis 403
8.2.167 GenMark Diagnostics Enters Into Co-Development Agreement With Advanced Liquid Logic For
Integrated Diagnostic Platform 404
8.2.168 PerkinElmer Enters Into Licensing Agreement With GenMark Diagnostics For Microfluidics
Patent Portfolio 406
8.2.169 Bristol-Myers Squibb Enters Into Co-Development Agreement With Meso Scale 408
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8.2.170 Applied BioCode Enters Into Licensing Agreement With Douglas Scientific For Barcoded
Magnetic Beads Technology 409
8.2.171 Molecular Response Enters Into Co-Marketing Agreement With Transparent 410
8.2.172 IBM Enters Into Co-Development Agreement With Memorial Sloan-Kettering Cancer Center 411
8.2.173 QuantiScientifics Enters Into Co-Marketing Agreement With BioDot For A2 MicroArray System
412
8.2.174 INOVA Diagnostics Enters Into Licensing Agreement With AmberGen And Massachusetts
General Hospital For Two Autoantigen Biomarkers 413
8.2.175 Waters Enters Into Co-Marketing Agreement With Protea Biosciences Group For LASEI DP-
1000 415
8.2.176 Devicor Medical Products Enters Into Co-Marketing Agreement With Carbon Medical
Technologies 416
8.2.177 Diomics Enters Into Licensing Agreement With University of Arizona For DNA Collection
Technology 417
8.2.178 Sage-N Research Enters Into Technology Integration Agreement With IO Informatics 418
8.2.179 Mayo Medical Labs Enters Into Licensing Agreement With A&G Pharma For Progranulin Blood
Test 419
8.2.180 Abbott Enters Into Co-Development Agreement With Genetics Lab For Molecular Assay
Development 420
8.2.181 Avedro Enters Into Option Agreement With Cleveland Clinic To License Intellectual Property
Assets 421
8.2.182 GE Global Research Enters Into Co-Development Agreement With InDevR 422
8.2.183 Roche Enters Into Licensing Agreement With Life Technologies For PCR Technology 423
8.2.184 Vital Diagnostics Enters Into Distribution Agreement With Cardinal Health 424
8.2.185 Dako Enters Into Co-Development Agreement With Amgen 425
8.2.186 Iverson Genetic Diagnostics Enters Into Co-Development Agreement With Vanderbilt
University 426
8.2.187 RedHill Biopharma Enters Into Co-Development Agreement With Quest Diagnostics To
Develop MAP Test For Crohn's Disease 427
8.2.188 Thermo Fisher Scientific Extends Licensing Agreement With Wako Pure Chemical Industries
428
8.2.189 Dolomite Centre Enters Into Co-Development Agreement With GigaGen 429
8.2.190 Mitomics Enters Into Co-Marketing Agreement With LabMD For Prostate Core Mitomic Test 430
8.2.191 Fresh Start Private Management Enters Into Licensing Agreement With Glacier 431
8.2.192 IRIS Sample Processing Enters Into Distribution Agreement With Fisher HealthCare 432
8.2.193 Courtagen Life Sciences Enters Into Co-Development Agreement With Tetracore 433
8.2.194 Quanterix, Beth Israel Deaconess And Forsyth Institute Enter Into Partnership To Develop
Tuberculosis Test 434
8.2.195 Avesthagen Enters Into Co-Development Agreement With CosmosID 436
8.2.196 Siemens Healthcare Diagnostics Enters Into Co-Development Agreement With ViiV Healthcare
437
8.2.197 Siemens Healthcare Diagnostics Enters Into Co-Development Agreement With Tocagen 439
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8.2.198 Brooks Life Science Enters Into Licensing Agreement With The Scripps Research Institute 441
8.2.199 SDIX Enters Into Licensing Agreement With BD Diagnostic 443
8.2.200 Thermo Fisher Scientific Enters Into Distribution Agreement With BellBrook Labs 444
8.2.201 DuPont Enters Into Co-Development Agreement With OligoCo 445
8.2.202 Genzyme Enters Into Co-Marketing Agreement With Veracyte 447
8.2.203 Boulder Diagnostics Enters Into Licensing Agreement With Portland State University 448
8.2.204 Ventana Medical Systems Enters Into Co-Development Agreement With Bayer Pharma 449
8.2.205 Pressure BioSciences Enters Into Co-Marketing Agreement With Digilab 451
8.2.206 Agilent Technologies Enters Into Co-Development Agreement With Integrated Diagnostics 453
8.2.207 Ventana Medical Systems Enters Into Co-Development Agreement With Pfizer 454
8.2.208 Ventana Medical Systems Enters Into Licensing Agreement With Cell Signaling Technology 456
8.2.209 Dako Enters Into Co-Development Agreement With Amgen 458
8.2.210 Foundation Medicine Enters Into Co-Development Agreement With Sanofi For Genetic
Biomarkers And Potential Diagnostics 459
8.2.211 University Of North Dakota Enters Into Licensing Agreement With NeoMatrix 460
8.2.212 Amorfix Life Sciences Enters Into Licensing Agreement With JSW-Lifesciences 461
8.2.213 Syndax Pharma Enters Into Co-Development Agreement With Ventana Medical Systems 462
8.2.214 ZyGEM Enters Into Co-Development Agreement With USAMRIID 464
8.2.215 AEterna Zentaris Enters Into Co-Development Agreement With Ventana Medical Systems 465
8.2.216 Boulder Diagnostics Enters Into Licensing Agreement With RUNMC 467
8.2.217 HistoRx Enters Into Licensing Agreement With Yale University 468
9 Recent Developments 469
9.1 Strategy And Business Planning 469
9.1.1 Nov 28, 2012: Abbott Board Approves Separation Of AbbVie 469
9.1.2 Nov 27, 2012: Abbott Labs To Revamp India Operations 469
9.1.3 Nov 20, 2012: PerkinElmer Establishes New Direct Operations In Southern Africa 470
9.1.4 Nov 13, 2012: BG Medicine Provides Business Update 470
9.1.5 Nov 07, 2012: Namsa Expands Laboratory In Lyon, France 471
9.1.6 Nov 05, 2012: Flambeau Medical Markets Group Expands New Facility 472
9.1.7 Oct 16, 2012: Alliance HealthCare Services Announces Oncology Therapy Facilities Expansion
472
9.1.8 Oct 11, 2012: Quest Diagnostics To Cut 400-600 Management Jobs; Creates Two New Business
Structures 473
9.1.9 Oct 08, 2012: DSM Pharma And Almac Sign Collaboration Agreement In Biocatalysis 474
9.1.10 Oct 02, 2012: AIBioTech Expands Bioorganic Chemistry Platform 474
9.1.11 Sep 28, 2012: Sigma-Aldrich Invests In Scotland 475
9.1.12 Sep 19, 2012: Fidelis Diagnostics Opens New Office In Denver, Colorado 475
9.1.13 Sep 18, 2012: CML HealthCare Announces Strategic Plan And Senior Management
Enhancements 476
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9.1.14 Sep 18, 2012: Hycor Opens European Center Of Operations In Germany To Support European
Distributors And Customers 477
9.1.15 Sep 17, 2012: Pathway Genomics And MD Revolution Partner To Incorporate Genomic And
Mobile Health Technologies Into Chronic Disease Management And Prevention 477
9.1.16 Sep 17, 2012: Boehringer Ingelheim To ShutDown One API Plant In Petersburg, Virginia 478
9.1.17 Sep 12, 2012: Nordion Announces Strategic Realignment Of Business 478
9.1.18 Sep 10, 2012: Icon Expands US And UK Bioanalytical Laboratories 479
9.1.19 Sep 07, 2012: Charles River Opens New Biomedical Diagnostic Facility In Wilmington,
Massachusetts 480
9.1.20 Aug 29, 2012: Bio-Rad Opens Digital Biology Center To Develop Products For R&D Markets
Based On Its Droplet Digital Technology 480
9.1.21 Aug 14, 2012: Morphotek Opens New Manufacturing Plant In Exton, US 481
9.1.22 Aug 13, 2012: Elan Announces Plan To Spin-Off Discovery Science And Neotope Biosciences To
Shareholders 481
9.1.23 Aug 01, 2012: Baxter Breaks Ground On $1 Billion Manufacturing Plant In Georgia, US 483
9.1.24 Jul 24, 2012: Life Technologies And SATuRN Collaborate To Increase Access To HIV Testing In
Africa 483
9.1.25 Jul 20, 2012: Seegene To Make Partnership Push With New Multiplex Real-Time PCR Tech 484
9.1.26 Jun 26, 2012: Roche To Shut New Jersey Site, Eliminate 1,000 Jobs 485
9.1.27 Jun 21, 2012: Gentris Partners With Shanghai Institutes of Preventative Medicine 486
9.1.28 Jun 07, 2012: PerkinElmer To Create New Personalized Health Innovation Center of Excellence
In Massachusetts, US 487
9.1.29 Jun 05, 2012: Roche Diagnostics Enters Strategic Alliance With med fusion That Recognizes As
Roche MCOE 487
9.1.30 May 31, 2012: N-of-One Signs Agreement With Foundation Medicine To Provide First Patient-
Specific Genomic Diagnostic Solution For Precision Oncology 488
9.1.31 May 23, 2012: Cold Spring Harbor Laboratory Joins Illumina Genome Network 488
9.1.32 May 22, 2012: New York Genome Center Announces Formal Commencement Of Collaborative
Relationship With Illumina 489
9.1.33 May 14, 2012: KineMed And CHDI Foundation Collaborate To Develop New Biomarkers Of
Disease Progression And To Evaluate Potential Therapeutics For Huntington‘s Disease 490
9.1.34 May 07, 2012: Werfen Decides To End Beckman Coulter Hemostasis Alliance 490
9.1.35 Apr 24, 2012: Reaction Biology Opens New Protein Production Facility In US 491
9.1.36 Apr 24, 2012: Luminex Expands Life Science And Biodefense Groups 491
9.1.37 Apr 23, 2012: Life Technologies To Build Additional $20m Cell Culture Facility In Scotland 492
9.1.38 Apr 02, 2012: CaridianBCT And Terumo Transfusion Become Terumo BCT 492
9.1.39 Mar 19, 2012: OPKO Health Expands Collaboration With Arctic Partners 493
9.1.40 Mar 12, 2012: Nelson Labs Acquires Building To Accommodate Growth 493
9.1.41 Mar 12, 2012: SAW Instruments Expands Presence In US 494
9.1.42 Mar 06, 2012: Lab21 And ITOR Launch Clinical Genomics Center In US 494
9.1.43 Mar 06, 2012: Almac Adds New Commercial Packaging Facility In Audubon, Pennsylvania 495
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9.1.44 Mar 02, 2012: Rubicon Genomics Selects Velesco To Manufacture TransPLEX RNA
Amplification Kits For Clinical Diagnostic Use 495
9.1.45 Mar 01, 2012: Abbott To Build Nutrition Manufacturing Facility In Ohio 496
9.1.46 Feb 27, 2012: Trovagene Partners With Leomics To Expand Business Development Activities 497
9.1.47 Feb 14, 2012: BD And PEPFAR Launch Center For Excellence In Phlebotomy And Specimen
Collection At KMTC 497
9.1.48 Jan 24, 2012: Precision Therapeutics Enhances Straightforward Approach To Personalizing
Cancer Care 498
9.1.49 Jan 24, 2012: Radient Pharma Introduces Its 2012 Sales, Advertising And Outreach Plan
Presentation 498
9.1.50 Jan 19, 2012: BD And Mercy/ROi Collaborate To Improve Quality Of Care And Reduce Costs 499
9.1.51 Jan 06, 2012: Thermo Fisher Scientific Introduces Unity Lab Services 500
9.1.52 Jan 05, 2012: MonoSol And Midatech Launch MidaSol Therapeutics 501
9.2 Research And Development 501
9.2.1 Nov 07, 2012: MJFF And NINDS Collaborate On Parkinson's Disease Biomarker Discovery
Project 501
9.2.2 Oct 29, 2012: Agfa HealthCare And Le CHU de Quebec Announce Three-Year Collaboration To
Conduct Research For Integrated Digital Pathology Solution 502
9.2.3 Sep 19, 2012: Ten Pharmaceutical Companies Unite To Accelerate Development Of New
Medicines 503
9.2.4 Aug 15, 2012: Biogen Idec And Regulus Therapeutics Form Collaboration To Explore microRNA
Biomarkers For Disease Monitoring And Response To Therapy 504
9.2.5 Aug 15, 2012: Epic Sciences Announces Six Pharma Circulating Tumor Cell Collaborations 504
9.2.6 Apr 23, 2012: Ezose And Hirosaki University To Collaborate In Glycomics Research To Find New
Cancer Biomarkers 505
9.2.7 Apr 02, 2012: Metabolon Enters Biomarker Research Collaboration With Metabolon 505
9.2.8 Mar 20, 2012: Transgenomic And MD Anderson Collaborate On Circulating Tumor Cell Study
Using ICE COLD-PCR 506
9.2.9 Mar 14, 2012: GE Healthcare And Intel To Establish Companies‘ First Joint Technology
Evaluation Laboratory In Israel 506
9.2.10 Mar 08, 2012: Covidien Opens Four Global R&D Centers To Broaden Innovation Focus And
Capabilities 507
9.2.11 Jan 12, 2012: Alere Maintains Exclusive Option To License Miraculins 508
9.2.12 Jan 09, 2012: Bayer HealthCare To Share Lab Space With Start-Up Companies 508
9.3 Legal and Regulatory 509
9.3.1 Nov 09, 2012: Novartis‘s Colorado Facility Obtains Clearance From FDA Inspectors 509
9.3.2 Nov 07, 2012: Fluidigm Files Lawsuit Against NanoString For False And Misleading Advertising
Under Lanham Act 509
9.3.3 Nov 02, 2012: Enzo Awarded $49m In Trial Against Applera 510
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9.3.4 Oct 22, 2012: Alere Receives FDA Warning Letter Over Weak Response To Manufacturing
Errors 510
9.3.5 Oct 18, 2012: Complete Genomics Announces Court's Favorable Ruling In Patent Litigation
Against Illumina 510
9.3.6 Oct 15, 2012: Genetic Technologies Files Patent Infringement Suits Against Multiple Alleged
Infringers In US 511
9.3.7 Oct 15, 2012: AspenBio Pharma Proposes Corporate Name Change To Venaxis 511
9.3.8 Oct 15, 2012: Fluxion Registers South San Francisco Facility As Medical Device Establishment
With FDA 512
9.3.9 Oct 11, 2012: CorMedix Announces Successful Completion Of ISO 13485 Certification Audit 512
9.3.10 Oct 04, 2012: Hologic Announces Favorable Ruling In Litigation With Becton, Dickinson 512
9.3.11 Sep 26, 2012: Abaxis Announces Settlement Of Patent Litigation With Cepheid 513
9.3.12 Sep 18, 2012: AspenBio Announces Dismissal Of Class Action And Chipman Lawsuits By US
District Court 513
9.3.13 Sep 13, 2012: Promega Announces Federal Judge Overturns Jury Verdict In Patent Rights Case
514
9.3.14 Sep 10, 2012: Nordion Announces Decision In Arbitration With AECL Over Canceled MAPLE
Project 514
9.3.15 Sep 05, 2012: RayBiotech Establishes Formal Compliance In Both Good Manufacturing And
Good Laboratory Practices 515
9.3.16 Aug 30, 2012: Genetic Technologies Files Patent Infringement Suit Against Reproductive
Genetics Institute In US 516
9.3.17 Aug 29, 2012: Illumina Announces Favorable Outcome Of Patent Litigation Against Helicos
BioSciences 516
9.3.18 Aug 23, 2012: United Drug Files Motion To Dismiss Legal Action By Catalent Pharma 517
9.3.19 Aug 20, 2012: Agendia Receives ISO Certification For Facilities In Amsterdam And Irvine 517
9.3.20 Aug 17, 2012: LabCorp Commends CDC For Revised HCV Testing Guidelines 518
9.3.21 Aug 16, 2012: US Court of Appeals Upholds Myriad's Gene Patents 518
9.3.22 Aug 10, 2012: EKF Announces Settlement Agreement With HemoCue 519
9.3.23 Aug 03, 2012: Meso Scale Diagnostics Announces ISO 9001:2008 And ISO 13485:2003
Certifications 519
9.3.24 Aug 01, 2012: MDxHealth CLIA Laboratory In California Receives CAP Accreditation 520
9.3.25 Jul 30, 2012: HTG Molecular Diagnostics Achieves ISO 13485:2003 Certification 520
9.3.26 Jul 24, 2012: PerkinElmer Receives State of Connecticut Clinical Laboratory Licensure And CLIA
Certificate Of Registration For Global DNA Sequencing Services 520
9.3.27 Jul 11, 2012: FDA Issues Class I Recall On Alere Triage Diagnostic Tests 521
9.3.28 Jul 09, 2012: Siemens Receives FDA Warning Letter For Violations Of CGMP Requirements 521
9.3.29 Jul 06, 2012: Sequenom Addresses Preliminary Injunction Decision, Reaffirms Defense Of Patent
522
9.3.30 Jun 28, 2012: Nodality Receives CLIA Certification For Clinical Laboratory 522
9.3.31 Jun 27, 2012: Excelsior Medical Retracts False Statements, Settles Case With Ivera Medical 523
9.3.32 Jun 18, 2012: Illumina Files Second Patent Infringement Suit Against Complete Genomics 523
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9.3.33 Jun 12, 2012: Progenika Receives CAP Certification For Its CLIA Labs 524
9.3.34 May 18, 2012: Champions Oncology Receives CLIA Certification 524
9.3.35 May 14, 2012: Helicos Settles Its Patent Litigation Against Pacific Biosciences 524
9.3.36 May 14, 2012: Helicos Settles Patent Litigation Against Pacific Biosciences 525
9.3.37 May 10, 2012: Metabolon‘s Shanghai Jiao Tong University Lab Receives Validation 525
9.3.38 May 08, 2012: Beckman Coulter Receives CLIA Certificate And Licensure For Clinical
Sequencing 525
9.3.39 Apr 30, 2012: Vermillion Resolves Non-Contingent Claims With Bio-Rad 526
9.3.40 Apr 24, 2012: FDA Notifies Class I Recall Of Roche‘s Elecsys Troponin I and Elecsys Troponin I
STAT Immunoassays 526
9.3.41 Apr 23, 2012: Essential Medical Dismisses Patent Case Against Masimo And Cercacor 527
9.3.42 Mar 26, 2012: Supreme Court of the United States Remands Gene Patenting Case 527
9.3.43 Mar 15, 2012: QIAGEN Welcomes US Guideline Changes To Recommend HPV Testing As Part
Of Cervical Cancer Screening 528
9.3.44 Mar 15, 2012: Seahorse Bioscience‘s Labware Division Achieves ISO 9001:2008 Certification 529
9.3.45 Mar 13, 2012: Roche Receives Request For Additional Information From FTC 530
9.3.46 Mar 05, 2012: Atossa Genetics' National Reference Laboratory For Breast Health Receives CLIA
Certification 530
9.3.47 Mar 01, 2012: Illumina Announces Outcome Of First Phase Of Its Patent Litigation Against
LadaTech 531
9.3.48 Mar 01, 2012: Berg Diagnostics Receives CLIA Certification And Launches New Vitamin D Assay
531
9.3.49 Mar 01, 2012: LadaTech Announces Illumina Found To Infringe Patent 532
9.3.50 Feb 22, 2012: Sequenom Files Motion For Preliminary Injunction Against Aria Diagnostics 532
9.3.51 Feb 21, 2012: Genetic Technologies Successfully Concludes Second Patent Infringement Suit In
US 533
9.3.52 Feb 16, 2012: Illumina Announces Favorable Patent Claim Construction Ruling In Litigation
Against Complete Genomics 533
9.3.53 Feb 03, 2012: London High Court Affirms 3M Legal Victory; Awards Company Litigation Fees
And Costs 533
9.3.54 Feb 01, 2012: Foundation Medicine Receives CLIA Certification For Its Genomic Sequencing
Laboratory 534
9.3.55 Jan 22, 2012: MDxHealth Receives CLIA Certification And California State License For Its
Clinical Laboratory 535
9.3.56 Jan 18, 2012: PrimeraDx Receives ISO 13485:2003 Certification 535
9.3.57 Jan 17, 2012: Agilent Technologies Lists LC And Mass Spec Systems As Class I Medical
Devices With FDA 536
9.3.58 Jan 11, 2012: Biotage Is Subject To Extended Patent Litigation In US 536
9.3.59 Jan 10, 2012: US Court of Appeals Upholds Celsis IVT Injunction Against Life Technologies In
LiverPool Patent Infringement Lawsuit 537
9.3.60 Jan 09, 2012: Transgenomic And Power3 Medical Resolve All Outstanding Litigation Proceedings
And Disputes 537
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9.4 Government and Public Interest 538
9.4.1 Nov 21, 2012: OraSure Supports New Routine HIV Screening Recommendations By US
Preventive Services Task Force 538
9.4.2 Nov 20, 2012: New Test For Tuberculosis Could Improve Treatment, Prevent Deaths In Southern
Africa: Study 539
9.4.3 Nov 20, 2012: ACOG Finds cffDNA Test To Be Promising Against Three Genetic Disorders 540
9.4.4 Nov 02, 2012: CMS Issues Final Rule On Medicare‘s Payments For Physician Fees For 2013 540
9.4.5 Nov 01, 2012: Researchers Use Blood Testing To Predict Level Of Enzymes That Facilitate
Disease Progression 541
9.4.6 Oct 16, 2012: New Noninvasive Test For Colorectal Cancer Shows Promise: AACR 542
9.4.7 Oct 15, 2012: VeriStrat Predicts Response But Not Survival Benefit From Erlotinib: Study 543
9.4.8 Aug 16, 2012: CDC Now Recommends All Baby Boomers Receive One-Time Hepatitis C Test 543
9.4.9 Aug 06, 2012: Cytomedix Announces Medicare Coverage For Autologous PRP Gel In Chronic
Wound Care 544
9.4.10 Jun 25, 2012: Loyola University Chicago Stritch School of Medicine Study Of Two Vitamin D
Tests Find Inaccurate 545
9.4.11 Jun 21, 2012: Blood Test For Pregnant Women Could Predict Risk Of Having Dangerously Small
Babies 545
9.4.12 Jun 20, 2012: UW Research Shows New Prognosis Tool For Deadly Brain Cancer 546
9.4.13 Jun 19, 2012: Genetic Marker In Vitamin D Receptor Gene Associated With Increased Pancreatic
Cancer Survival 547
9.4.14 Jun 15, 2012: US Senator John Kerry Introduces Senate Resolution Urging Federal Support To
Improve Early Detection Of Prostate Cancer 548
9.4.15 Jun 05, 2012: Noninvasive Genetic Test For Down Syndrome And Edwards Syndrome Highly
Accurate: Study 549
9.4.16 Jun 05, 2012: Blood Test Identifies Increased Risk Of Death Following Surgery: McMaster
Researchers 550
9.4.17 Jun 05, 2012: Battelle Introduces Industry-First Drug Discovery CoLaborative 551
9.4.18 Jun 02, 2012: Researchers Discover DNA Marker That May Indicate Differences In Breast
Cancer 552
9.4.19 May 31, 2012: Researchers Identify Promising Biomarkers And New Therapeutic Targets For
Kidney Cancer: UC Davis 553
9.4.20 May 31, 2012: Nanotechnology Advancement Could Significantly Improve Medical Tests:
Princeton University 554
9.4.21 May 29, 2012: Researchers Discover Biomarker For Advanced Bile Duct Fibrosis And Bile Duct
Cancer: The George Washington University 555
9.4.22 May 24, 2012: New Prostate Cancer Screening Guidelines Face Tough Sell, Study Suggests 556
9.4.23 May 22, 2012: New Biomarkers Reveal Evidence Of Radiation Exposure: Medical College of
Wisconsin 557
9.4.24 May 22, 2012: Biomedical Engineers At UC Davis Develops Microfluidic Chip To Test For Latent
Tuberculosis 558
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9.4.25 May 19, 2012: CDC Announces First Ever National Hepatitis Testing Day And Proposes That All
Baby Boomers Be Tested Once For Hepatitis C 559
9.4.26 May 17, 2012: Researchers From University of Florida Uses Traditional Microscope-Based
Diagnosis Method As Starting Point Against Tuberculosis 560
9.4.27 May 17, 2012: NIH-Led Study Finds Genetic Test Results Do Not Trigger Increased Use Of
Health Services 561
9.4.28 May 15, 2012: New Biomarker Test Predicts Arthritis At Much Earlier Stage: University of
Missouri-Columbia 562
9.4.29 May 15, 2012: Early Biomarker For Pancreatic Cancer Identified: University of California, San
Diego 563
9.4.30 May 15, 2012: FDA Expands Use For FilmArray Respiratory Panel 564
9.4.31 May 14, 2012: Genetic Test Identifies Eye Cancer Tumors Likely To Spread: Washington
University School of Medicine 565
9.4.32 May 07, 2012: PSA Screening To Detect Prostate Cancer Can Be Beneficial To Younger And At-
Risk Men: New Study 566
9.4.33 Apr 25, 2012: New Diagnostic Tool Determines Aggressiveness Of Prostate Cancer: UCF 567
9.4.34 Apr 24, 2012: New Microdevice Enables Culture Of Rare Circulating Tumor Cells From Blood 568
9.4.35 Apr 18, 2012: Researchers Develop New Optical Imaging System For Rapid And Accurate
Diagnosis Of Malaria 569
9.4.36 Apr 17, 2012: Saliva Test Could Dramatically Increase Detection Of Oral Cancer: MSU 570
9.4.37 Apr 17, 2012: Northwestern Medicine Scientist Develops First Blood Test To Diagnose Major
Depression In Teens 571
9.4.38 Apr 16, 2012: Biosensia To Showcase Latest Diagnostic Developments At AACC Oak Ridge
Conference 572
9.4.39 Apr 09, 2012: Researchers Identify Genes That May Help In Ovarian Cancer Diagnosis And
Prognosis 572
9.4.40 Apr 06, 2012: Invasive Heart Test Being Dramatically Overused, Stanford Study Shows 573
9.4.41 Apr 05, 2012: Cleveland HeartLab‘s Cardiovascular Disease Risk Testing To Be Featured At
TEDMED 2012 574
9.4.42 Apr 04, 2012: Caris Life Presents Novel Findings Regarding Biological Role Of Circulating
Microvesicles 575
9.4.43 Mar 31, 2012: Biomarker Identified In Relation To Drug Response In Refractory Urothelial Cancer
576
9.4.44 Mar 29, 2012: Complete Genomics Accepts DNA Obtained From Saliva For Whole Human
Genome Sequencing 576
9.4.45 Mar 27, 2012: Siemens Showcases Broad Portfolio Of Infectious Disease Testing Capabilities At
ECCMID 2012 577
9.4.46 Mar 20, 2012: Study Shows Colorectal Cancer Screening Rates High In Patients With Multiple
Health Problems 577
9.4.47 Mar 16, 2012: FDA Proposes Lower Risk Classification For Certain Tuberculosis Tests 578
9.4.48 Mar 16, 2012: Inflammatory Biomarkers Improve Clinical Prediction Of Mortality In COPD 579
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9.4.49 Mar 15, 2012: New Professional Guidelines Recognize Benefit Of Genotyping HPV 16 And 18
For Cervical Cancer Prevention By Assessing Individual Patient Risk: Roche 580
9.4.50 Mar 14, 2012: Study Suggests Link Between Helicobacter pylori Bacteria And Adult Type 2
Diabetes 581
9.4.51 Mar 14, 2012: Predictive Biosciences To Present At GTCbio Oncology Biomarkers Conference
581
9.4.52 Mar 05, 2012: Pall Life Sciences Showcases Innovative Syringe Filter At Pittcon Conference 582
9.4.53 Feb 29, 2012: Cleveland Clinic Children's Hospital Launches Study To Genetically Test For
Autism 583
9.4.54 Feb 27, 2012: New Research Study Could Lead To More Timely Diagnosis And Aid Clinical
Management During Flu Season 584
9.4.55 Feb 04, 2012: Henry Ford Hospital Researchers Identity Potential Biomarker For Osteoarthritis
585
9.4.56 Feb 02, 2012: Scripps Research Scientists Demonstrate Effective New 'Biopsy In A Blood Test'
To Detect Cancer 585
9.4.57 Feb 02, 2012: Study Shows An Investigational Urine Test Can Predict High-Risk Prostate Cancer
In Men Who Choose ‗Watchful Waiting‘ 587
9.4.58 Feb 02, 2012: New Research Confirms Need For Lung Cancer Testing: UCCC 588
9.4.59 Feb 01, 2012: Blood Test Accurately Distinguishes Depressed Patients From Healthy Controls:
MGH 589
9.4.60 Jan 27, 2012: Bruker And SAT Announce Joint Publication On SISCAPA-MALDI-TOF Mass
Spectrometry For Biomarker Validation And Clinical Research 590
9.4.61 Jan 24, 2012: RI-MUHC-Led Study Compares Saliva Self-Test To Blood Test 591
9.4.62 Jan 19, 2012: AUA Applauds Passage Of New Jersey Legislation Opposing USPSTF PSA
Testing Recommendations And Guaranteeing Coverage 591
9.4.63 Jan 17, 2012: New Jersey Leads Nation In Opposing USPSTF PSA Testing Recommendation 592
9.4.64 Jan 12, 2012: Moffitt Cancer Center Researchers Find New, Noninvasive Way To Identify Lymph
Node Metastasis 593
9.4.65 Jan 12, 2012: NIH Scientists Identify New Approach To View Inner Workings Of Viruses 594
9.4.66 Jan 10, 2012: New Fibrosis Classification Improves Accuracy Of Diagnosis In Hepatitis C 595
9.4.67 Jan 10, 2012: GE Healthcare Presents At JP Morgan Healthcare Conference On Role Of
Molecular And Companion Diagnostics In Personalized Medicine 596
9.4.68 Jan 10, 2012: NIST Standard Available For Better Diagnosis, Treatment Of Cytomegalovirus 596
9.4.69 Jan 09, 2012: Most Parents Who Get Tested For Breast Cancer Genes Share Results With Their
Children: Study 597
9.4.70 Jan 09, 2012: Biomarkers Identify Acute Kidney Injury In Emergency Patients 598
9.4.71 Jan 08, 2012: New Test Spots Early Signs Of Inherited Metabolic Disorders: UC San Diego 598
9.5 Product News 599
9.5.1 Nov 28, 2012: Cdex To Showcase ValiMed G4 System At 47th ASHP Midyear Clinical Meeting
And Exhibition 599
9.5.2 Nov 28, 2012: Telome Health To Launch TeloTest In Q1 2013 600
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 22
9.5.3 Nov 27, 2012: CardioDx Announces Participation In Landmark NHLBI Trial Of Strategies For
Assessment Of Stable Patients With Symptoms Of CAD 601
9.5.4 Nov 19, 2012: Daxor Signs Trial Agreement With PCI Nuclear Pharmacy in Arizona For Blood
Volume Analyzer-100 602
9.5.5 Nov 15, 2012: CardioDx Announces Data Demonstrating Clinical Utility Of Its Gene Expression
Test For Obstructive Coronary Artery Disease In Patients 65 Or Older 602
9.5.6 Nov 14, 2012: Associates of Cape Cod Announces Use Of Fungitell Assay In Diagnosis Of
Invasive Fungal Infections 603
9.5.7 Nov 13, 2012: Nanosphere Receives FDA Clearance To Market Test For Detection Of CYP2C19
Mutations Affecting Drug Metabolism 603
9.5.8 Nov 12, 2012: CardioDx To Present Corus CAD At Lazard Capital Markets And Piper Jaffray
Investor Conferences 604
9.5.9 Nov 09, 2012: Natera‘s Non-Invasive Prenatal Testing Technology Shows Unparalleled
Specificity, Sensitivity In Clinical Data Presented At American Society of Human Genetics 604
9.5.10 Nov 08, 2012: Cytomedix Receives FDA 510(K) Clearance For Angel cPRP System For
Processing Blood And Bone Marrow Aspirate 605
9.5.11 Nov 08, 2012: CardioDx Announces New Data Supporting Clinical Utility And Validity Of Corus
CAD At American Heart Association Scientific Sessions 2012 606
9.5.12 Nov 08, 2012: Roche Receives Health Canada Approval For Cobas AmpliPrep/Cobas TaqMan
CMV Test 607
9.5.13 Nov 08, 2012: Diazyme Receives FDA 510(k) Clearance For Cystatin C POC Test Kit On Smart
Point of Care System 607
9.5.14 Nov 07, 2012: Life Technologies Announces Next-Gen Digital PCR Instrument Designed For
Widespread Adoption 608
9.5.15 Nov 07, 2012: Caris Life Sciences Selects Illumina‘s MiSeq System To Enable Next-Generation
Sequencing As Part Of Its Molecular Profiling Service 609
9.5.16 Nov 06, 2012: IntegenX Announces Commercial Introduction Of mRNA Library Preparation Kit
For Next Generation Sequencing 609
9.5.17 Nov 06, 2012: Affymetrix Introduces Axiom miRNA Target Site Genotyping Arrays 610
9.5.18 Nov 06, 2012: Verinata Health's verifi Prenatal Test Expanded To Include Most Common Sex
Chromosome Abnormalities 611
9.5.19 Nov 05, 2012: Atherotech‘s VAP Lipid Panel Helps Predict Heart Attack Risk And Improved
Outcomes In African Americans 611
9.5.20 Nov 05, 2012: Ariosa Diagnostics To Present Clinical Data On Harmony Prenatal Test At ASHG
Annual Meeting 612
9.5.21 Nov 01, 2012: Affymetrix Introduces Axiom Biobank Arrays For Genotyping Studies 613
9.5.22 Oct 29, 2012: Epocal Receives FDA Clearance For Chloride Test 614
9.5.23 Oct 29, 2012: CardioDx Announces Clinical And Scientific Presentations At American Heart
Association Scientific Sessions 2012 614
9.5.24 Oct 29, 2012: Epocal Receives FDA Clearance For Creatinine Test 615
9.5.25 Oct 25, 2012: Verinata Health Files Patent Infringement Action Against Ariosa And LabCorp 616
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
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9.5.26 Oct 24, 2012: Atherotech‘s VAP Lipid Panel Is Highlighted In Scientific Presentations At 2012
American Heart Association Scientific Sessions 616
9.5.27 Oct 24, 2012: Verinata Health Announces Presentations Of Its Verifi Prenatal Test At National
Society Of Genetic Counselors Conference 617
9.5.28 Oct 23, 2012: Cytonics Receives Notice Of Allowance For Patent Related To FACT Diagnostic
For Back And Joint Pain 618
9.5.29 Oct 22, 2012: Prometheus Presents Five Abstracts Of Prometheus Anser IFX Assay At ACG
2012 Scientific Meeting 619
9.5.30 Oct 18, 2012: HTG Molecular To Unveil Edge System At AMP Conference 619
9.5.31 Oct 12, 2012: SQI Diagnostics To Launch SQiDlite Multiplexing System At AAPS 620
9.5.32 Oct 11, 2012: Akonni Biosystems To Present Results Of Its Work To Develop TruTip Automated
Solution For Extracting Cell-Free DNA From Maternal Plasma At ASHG Conference 620
9.5.33 Oct 11, 2012: BD Veritor System For Rapid Detection Of RSV Receives FDA 510(k) Clearance
For Nasopharyngeal Wash, Aspirate And Swab In Transport Media Specimens 621
9.5.34 Oct 10, 2012: Myriad's HRD Score Detects Loss Of DNA Repair Function In Ovarian Cancer 622
9.5.35 Oct 09, 2012: Focus Diagnostics And 3M Launch FDA-Cleared Simplexa Test On 3M Cycler For
Molecular Influenza And Respiratory Virus Testing By Moderate Complexity Healthcare Facilities 622
9.5.36 Oct 09, 2012: OraSure Announces Availability Of OraQuick In-Home HIV Test To Consumers
Across US 623
9.5.37 Oct 03, 2012: Roche Announces Availability Of Cobas TaqMan HIV-1 Test v2.0 In US 624
9.5.38 Oct 03, 2012: BD Diagnostics Receives 510(k) FDA Clearance For Nasopharyngeal Wash,
Aspirate And Swab In Transport Media Specimens On BD Veritor System For Rapid Detection Of RSV 624
9.5.39 Oct 01, 2012: Inform Genomics Announces Positive Top-Line Results In First Phase Of
Development For Onpart Personalized Medicine Product 625
9.5.40 Oct 01, 2012: IntegenX Announces Commercial Availability Of RapidHIT 200 System In US 626
9.5.41 Oct 01, 2012: Micronics Announces Commercial Launch Of ABORhCard 626
9.5.42 Sep 27, 2012: Life Technologies Receives FDA Clearance For OpTmizer CTS T-Cell Expansion
Tissue Culture Medium 627
9.5.43 Sep 26, 2012: Aeterna Zentaris Provides Update On NDA Filing For AEZS-130 As Diagnostic
Test For Adult Growth Hormone Deficiency 628
9.5.44 Sep 26, 2012: PrimeraDx Receives National Cancer Institute Grant To Develop B-Cell
Lymphoma Panel On ICEPlex System 628
9.5.45 Sep 25, 2012: Gynecor Adds New Cervical Cancer LAB Technology To Help Physicians Identify
Patients At Risk For Cervical Cancer, Improve Treatment Decisions 629
9.5.46 Sep 25, 2012: Genetic Technologies Announces BREVAGen Attains Clearance For Sale Into
Florida 629
9.5.47 Sep 25, 2012: NanoString Launches Single Cell Gene Expression Solution For nCounter Analysis
System 630
9.5.48 Sep 24, 2012: Study At Columbia University Using Daxor's Blood Volume Analyzer Demonstrates
Hidden Polycythemia In Heart Failure Patients 631
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
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9.5.49 Sep 24, 2012: BD Diagnostics Receives FDA 510(k) Clearance For Nasopharyngeal Wash,
Aspirate And Swab In Transport Media Specimens On BD Veritor System For Rapid Detection Of Flu A +
B 631
9.5.50 Sep 24, 2012: Ariosa Diagnostics Announces Publication Of Clinical Study On Non-invasive
Prenatal Testing For Fetal Trisomy 13 With Harmony Prenatal Test 632
9.5.51 Sep 18, 2012: Fyodor Biotechnologies Receives Phase II SBIR Grant To Develop Broad Urine-
Based Diagnostic Test For Malaria 633
9.5.52 Sep 17, 2012: LipoScience Announces Publication Of Results From Clinical Study In American
Journal of Cardiology 633
9.5.53 Sep 17, 2012: Roche Announces Commercial Availability Of Cobas AmpliPrep/Cobas TaqMan
CMV Test In US 634
9.5.54 Sep 12, 2012: GenMark Diagnostics Receives FDA Clearance For eSensor RVP Test 635
9.5.55 Sep 11, 2012: Cytomedix To Highlight AutoloGel System In Multiple Poster Presentations At
SAWC Fall 2012 635
9.5.56 Sep 06, 2012: PTS Signs Agreement To Provide Point-of-Care Lipid Testing To Life Line
Screening 636
9.5.57 Sep 06, 2012: Polymer Technology Signs Agreement With Life Line Screening To Supply
CardioChek PA Test System 637
9.5.58 Sep 05, 2012: BioReliance To Launch Reconstructed Skin Micronucleus Assay 637
9.5.59 Sep 05, 2012: Cytomedix To Present AutoloGel System In Two Presentations At 4th Congress Of
WUWHS 2012 In Japan 638
9.5.60 Sep 05, 2012: Ariosa Diagnostics Reports Publication Of Clinical Utility Of Harmony Prenatal Test
In General Screening Population 639
9.5.61 Sep 05, 2012: LipoScience Receives FDA Clearance For Vantera Clinical Analyzer 640
9.5.62 Sep 04, 2012: Transgenomic And NYU Collaborate On Lung Cancer Study Using Ice Cold-PCR
For Blood-Based Mutation Detection 640
9.5.63 Aug 29, 2012: Siemens Unveils New Assay For Specific And Stable Free Protein S Antigen
Testing 641
9.5.64 Aug 16, 2012: AWDT Launches ACE Axcel Clinical Chemistry System 642
9.5.65 Aug 14, 2012: Beckman Coulter Announces Publication Of Positive Study Results In Journal of
The American College of Cardiology Distinguish PAPP-A From Other New Cardiovascular Biomarkers 643
9.5.66 Aug 14, 2012: CardioDx To Present Corus CAD At Wedbush PacGrow Life Sciences
Management Access Conference 644
9.5.67 Aug 14, 2012: California Schools VEBA Implements Pathway Fit Nutrigenetic Test For Weight-
Loss 644
9.5.68 Aug 13, 2012: Miraculins To Launch PreVu Skin Cholesterol Test In Canada Through London
Drugs 645
9.5.69 Aug 10, 2012: Miraculins To Receive $0.13m Grant For PreVu From Province of Manitoba 646
9.5.70 Aug 09, 2012: Veridex Reports Updated Coding And Payment On Horizon For Circulating Tumor
Cell Testing 646
9.5.71 Aug 08, 2012: CardioDx Announces Medicare Coverage For Corus CAD Gene Expression Test
For Diagnosis Of Obstructive Coronary Artery Disease 647
SAMPLE
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 25
9.5.72 Aug 07, 2012: LabCorp Completes And Publishes Clinical Study For Development And Validation
Of PCR Assay For Bacterial Vaginosis 648
9.5.73 Aug 07, 2012: AspenBio Pharma Submits Pre-IDE Information Package To FDA For AppyScore
Appendicitis Test System 648
9.5.74 Aug 07, 2012: Aeterna Zentaris Granted US Patent For AEZS-130 As Diagnostic Test For Adult
Growth Hormone Deficiency 649
9.5.75 Aug 06, 2012: SWOG Selects Sequenta‘s LymphoSIGHT Platform For Use In 180-Patient Mantle
Cell Lymphoma Clinical Trial 649
9.5.76 Aug 06, 2012: University of Michigan Informs Interleukin Genetics Of Study Results Using PST
Genetic Test In Determining Frequency Of Dental Cleanings 650
9.5.77 Aug 06, 2012: Cytomedix Announces Medicare Coverage For Autologous PRP Gel In Chronic
Wound Care 651
9.5.78 Aug 03, 2012: Daxor Announces Sale Of BVA-100 Blood Volume Analyzer To Hospital Located
In Arizona 652
9.5.79 Aug 02, 2012: Idaho Technology Provides FilmArray Clinical Diagnostic Pipeline Update 652
9.5.80 Aug 01, 2012: AspenBio Pharma Enhances Product Development And Manufacturing
Capabilities In Preparation For Clinical Trial And Commercialization Of AppyScore 653
9.5.81 Jul 31, 2012: CardioDx‘s Corus CAD Gene Expression Test Performs Equally Well In Both
Women And Men for Assessment Of Obstructive Coronary Artery Disease: New Study 654
9.5.82 Jul 31, 2012: New York Genome Center Purchases Four Ion Proton Sequencers For Its New
Innovation Center 655
9.5.83 Jul 31, 2012: Prometheus Launches PROMETHEUS Anser IFX To Help Guide Inflammatory
Bowel Disease Management 656
9.5.84 Jul 30, 2012: MolecularMD Submits PMA Application To FDA For BCR-ABL T315I Mutation Test
656
9.5.85 Jul 30, 2012: 23andMe Submits First Round Of FDA 510(k) Documentation To FDA 657
9.5.86 Jul 26, 2012: RainDance Technologies Launches First Access Program For RainDrop Digital
PCR System 658
9.5.87 Jul 25, 2012: Cepheid Announces Release Of Updated Xpert BCR-ABL Monitor Test 659
9.5.88 Jul 25, 2012: Genomic Health Announces Publication Of Clinical Outcomes Study For Biomarker
Discovery Using Next Generation Sequencing 659
9.5.89 Jul 24, 2012: Aeterna Zentaris Requests Fast Track Designation From FDA For AEZS-130 As
Diagnostic Test For AGHD 660
9.5.90 Jul 24, 2012: Genalyte Launches Maverick ENA 4 Assay Kit 661
9.5.91 Jul 24, 2012: Ariosa Diagnostics Completes Clinical Study Of Harmony Prenatal Test On General
Pregnant Patient Population 661
9.5.92 Jul 23, 2012: FDA Grants CLIA Waiver To bioLytical INSTI Rapid HIV Test 662
9.5.93 Jul 19, 2012: T2 Biosystems Announces Data Presentation On T2Hemostasis At American
Association for Clinical Chemistry Annual Meeting 663
9.5.94 Jul 19, 2012: CBLPath Launches NRAS Gene Mutation Analysis Assay 664
9.5.95 Jul 18, 2012: Daxor Announces Placement Of BVA-100 Blood Volume Analyzer At New York
Presbyterian/Weill Cornell Medical Center 664
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 26
9.5.96 Jul 17, 2012: Beckman Coulter‘s New AU5800 System Featured At 2012 AACC/ASCLS Annual
Meeting And Clinical Lab Expo 665
9.5.97 Jul 17, 2012: BD Receives FDA 510(k) Clearance For BD BACTEC Plus Aerobic/F Blood Culture
Plastic Bottles 666
9.5.98 Jul 17, 2012: Idaho Technology Initiates Clinical Study For FilmArray Blood Culture Identification
Panel 666
9.5.99 Jul 16, 2012: Roche Introduces Mobile Blood Gas Analyzer For Hospital Point Of Care 667
9.5.100 Jul 16, 2012: Metabolon To Showcase Quantose Test At AACC Clinical Lab Expo 667
9.5.101 Jul 12, 2012: Daxor Announces Placement Of BVA-100 Blood Volume Analyzer At North
Alabama Radiopharmacy 668
9.5.102 Jul 11, 2012: Idaho Technology To Present At 2012 AACC Annual Meeting 668
9.5.103 Jul 11, 2012: Courtagen Releases nucSEEKPDx 669
9.5.104 Jul 09, 2012: Genomic Health Releases Results Of Oncotype DX Breast Cancer Test 669
9.5.105 Jul 09, 2012: SurModics IVD To Launch BioFX TMBX At AACC In Los Angeles 670
9.5.106 Jul 06, 2012: QIAGEN Receives FDA Approval Of Therascreen KRAS RGQ PCR Kit For
Colorectal Cancer 671
9.5.107 Jul 06, 2012: Court Denies Preliminary Injunction Motion Against Ariosa Diagnostics 672
9.5.108 Jul 03, 2012: OraSure Receives FDA Clearance For Its OraQuick In-Home HIV Test 672
9.5.109 Jul 02, 2012: Roche Receives FDA Approval For COBAS TaqMan HIV-1 Test 673
9.5.110 Jul 02, 2012: Verinata Health Expands verifi Prenatal Test To Include Turner Syndrome Option
673
9.5.111 Jul 02, 2012: Seegene To Introduce Real-Time Multiple Mutation Detection Technology For
Drug Resistant Mutations In M. tuberculosis At AACC 2012 674
9.5.112 Jun 28, 2012: Abaxis Enters Into Definitive Agreement To Deliver 300 Piccolo Xpress
Instruments For Four-Year Drug Clinical Trial 674
9.5.113 Jun 28, 2012: IBM Recommends Strategy To Help Improve Cervical Cancer Screening And
Treatment In Kenya 675
9.5.114 Jun 27, 2012: OraSure Supports Rapid HIV Testing Initiatives In Recognition Of 18th Annual
National HIV Testing Day 676
9.5.115 Jun 26, 2012: BIT Companies And DRG Diagnostics To Unveil DRG:HYBRID XL Analyzer 677
9.5.116 Jun 26, 2012: WIN Consortium To Initiate Clinical Trial Using Foundation Medicine‘s
FoundationOne 677
9.5.117 Jun 23, 2012: BD Biosciences Launches BD FACSJazz Cell Sorting System 678
9.5.118 Jun 23, 2012: Quantimetrix Launches Complete D 25-OH Vitamin D Control 678
9.5.119 Jun 22, 2012: Accelr8 Presents Study Results For BAC-Xtrax At ASM 2012 679
9.5.120 Jun 22, 2012: Accelr8 Presents Study Results For BACcel Rapid Diagnostic System At ASM
2012 And Receives Acceptance To Present New Blood Study 679
9.5.121 Jun 21, 2012: Siemens Launches Enzygnost Anti-HCV 4.0 Assay 679
9.5.122 Jun 21, 2012: Daxor Announces Placement Of Three BVA-100 Blood Volume Analyzers 680
9.5.123 Jun 20, 2012: BioRealm Secures SBIR Contract To Develop Smokescreen For Tobacco
Addiction 680
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
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9.5.124 Jun 11, 2012: Metabolon‘s Quantose IR Test Featured In Five Poster Presentations At 2012
American Diabetes Association Meeting 681
9.5.125 Jun 08, 2012: Cytomedix To Present Multiple Poster Presentations On AutoloGel System At
44th Annual Conference Of WOCN 682
9.5.126 Jun 07, 2012: QuantRx Biomedical Provides Corporate Update: Focused On Diagnostics And
Feminine Hygiene Segments 682
9.5.127 Jun 07, 2012: Chembio Files PMA Final Module With FDA For DPP HIV 1/2 Assay 683
9.5.128 Jun 05, 2012: Transgenomic Launches ICE COLD-PCR Kit At 2012 ASCO Annual Meeting 684
9.5.129 Jun 05, 2012: Prospective Study Shows Favorable Overall Survival In Cancer Of Unknown
Primary Patients With Therapy Directed By bioTheranostics' CancerTYPE ID 685
9.5.130 Jun 04, 2012: Quantimetrix Introduces Dropper A1c Diabetes Control 686
9.5.131 Jun 04, 2012: Ariosa Diagnostics Completes First Large Cohort Validation Study On Non-
invasive Prenatal Testing For Fetal Trisomy Detection Using Harmony Prenatal Test 686
9.5.132 Jun 01, 2012: NLA Abstracts Examine Clinical Utility Of Atherotech‘s VAP Lipid Panel In Type
2 Diabetes Treatment, Heart Disease Risk Assessment 687
9.5.133 Jun 01, 2012: ScotlandsDNA Selects DNA Genotek‘s Oragene•DNA Kit For Ancestry Testing
688
9.5.134 Jun 01, 2012: bioTheranostics‘ CancerTYPE ID Shows High Accuracy In A Multi-Site Validation
Study And Improved Performance Compared With Standard Of Care In Metastatic Tumor Diagnosis 689
9.5.135 Jun 01, 2012: LipoScience Announces Study Results Of LDL Particle Levels Using NMR
LipoProfile Test 690
9.5.136 Jun 01, 2012: Salimetrics Introduces New Salivary IL-1 Beta Immunoassay Kit 691
9.5.137 May 31, 2012: Pathwork Diagnostics To Present Three Studies At ASCO Annual Meeting 691
9.5.138 May 31, 2012: Illumina Introduces Nextera XT DNA Sample Preparation Kit 692
9.5.139 May 31, 2012: Verinata Health Announces Introduction Of verifi Prenatal Test 693
9.5.140 May 31, 2012: CardioDx To Present Corus CAD At Jefferies 2012 Global Healthcare
Conference 694
9.5.141 May 30, 2012: Response Genetics Announces Presentation Of Lung Cancer Study Results At
2012 ASCO Annual Meeting 694
9.5.142 May 30, 2012: Biocept To Present Clinical Findings On Circulating Tumor Cells At ASCO
Annual Meeting 695
9.5.143 May 30, 2012: BHD Launches SLCO1B1 Genotype Test To Identify Risk For Developing
Debilitating Myopathy 696
9.5.144 May 29, 2012: Sequenom Reports Recently Released Publication On Sequenom Massarray
Research Use System 697
9.5.145 May 29, 2012: Corgenix Announces Issuance Of Additional US Patent For AspirinWorks (11-
dehydro Thromboxane B2) Test 697
9.5.146 May 29, 2012: Siemens Receives FDA Warning Letter Regarding AD VIA Centaur iPTH
Immunoassay 698
9.5.147 May 24, 2012: Cepheid Receives FDA Clearance For GeneXpert Infinity-80 System For Initial
Use With Xpert Flu Assay 698
9.5.148 May 24, 2012: True Diagnostics Receives CE Mark For TrueDX Platform And TSH Test 699
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 28
9.5.149 May 23, 2012: Lucigen Corporation Receives $2.8m SBIR Grant From NIH For Lucigen
Influenza A, B & RSV test 699
9.5.150 May 21, 2012: HistoRx Announces Application Of AQUA Technology To Assessment Of
Messenger RNA In Tissue 700
9.5.151 May 21, 2012: AB Sciex Launches Next-Generation TripleTOF 5600 System 701
9.5.152 May 21, 2012: Transgenomic Announces CE IVD Mark For WAVE MCE System 702
9.5.153 May 18, 2012: OraSure Technologies Issues Statement On CDC Proposed Draft Guidelines
For Testing Of Baby Boomers For Hepatitis C 702
9.5.154 May 18, 2012: Siemens Receives FDA Clearance For RAPIDPoint 500 System - Lactate Assay
703
9.5.155 May 18, 2012: Siemens Receives CE Mark Approval For RAPIDPoint 500 System - Pleural
Fluid pH Testing 703
9.5.156 May 18, 2012: Sequenom Announces Publication Of Clinical Study Results Using CMM's
MaterniT21 PLUS LDT 704
9.5.157 May 16, 2012: NanoString Initiates Second Clinical Validation Study For PAM50-Based Breast
Cancer Assay 705
9.5.158 May 15, 2012: OraSure‘s OraQuick In-Home HIV Test Receives Unanimous Positive
Recommendation From FDA Advisory Committee 706
9.5.159 May 15, 2012: Accelr8 And Denver Health Secure $2m Rapid Diagnostics Grant From
Department of Defense 707
9.5.160 May 15, 2012: Idaho Technology Receives FDA 510(k) Clearance For Expanded FilmArray
Respiratory Panel 707
9.5.161 May 14, 2012: EMD Millipore's Muse Cell Analyzer Wins Red Dot Design Award 2012 708
9.5.162 May 09, 2012: Sequenom Signs Agreement With Coventry Health Care National Network For
CMM MaterniT21 PLUS LDT 709
9.5.163 May 07, 2012: CardioDx To Present Results From Two Studies Evaluating Clinical Utility Of
Corus CAD Gene Expression Test For Obstructive Coronary Artery Disease 709
9.5.164 May 07, 2012: Ariosa Diagnostics Announces Nationwide Launch Of Harmony Prenatal Test
Through LabCorp 710
9.5.165 May 03, 2012: DNA Genotek Announces Recipients Of DNA Genotek Grant Program 710
9.5.166 May 02, 2012: Trovagene Announces Plans To Develop New Test For High Risk HPV Carrier
Screening From Urine 711
9.5.167 May 01, 2012: Singulex Adds Erenna Interleuken -17A/F To Suite Of TH17 Pathway
Immunoassay Kits 712
9.5.168 Apr 30, 2012: Siemens Receives CE Mark For New Urine Chemistry Analyzer 713
9.5.169 Apr 30, 2012: CardioDx Wins Edison Award For Corus CAD 714
9.5.170 Apr 26, 2012: New Clinical Endocrinology Guidelines Support Lp-PLA2 Measurement For Risk
Assessment Of Coronary Artery Disease: diaDexus 714
9.5.171 Apr 26, 2012: Luminex Receives CE Mark For xMAP NeoPlex4 Assay 715
9.5.172 Apr 25, 2012: Quest Diagnostics Announces C9orf72 Genetic Test For Lou Gehrig's Disease
716
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 29
9.5.173 Apr 25, 2012: Idaho Technology's FilmArray RP Demonstrates Significant Workflow Benefit
And Pathogen Specificity 716
9.5.174 Apr 24, 2012: Life Technologies Installs Ion Proton Systems At BCM-HGSC Center, Texas 717
9.5.175 Apr 20, 2012: Quidel Receives CLIA Waiver For Sofia Analyzer And Sofia Influenza A+B FIA
718
9.5.176 Apr 19, 2012: IMDx To Present Development Of Fully Automated Molecular Test For Detection
Of Influenza A/B And RSV At 28th Annual Clinical Virology Symposium 718
9.5.177 Apr 19, 2012: Idaho Technology To Highlight Diagnostic FilmArray Respiratory Panel At 28th
Annual Clinical Virology Symposium 719
9.5.178 Apr 19, 2012: T2 Biosystems Announces Data Presentation On T2Hemostasis At 44th Annual
Oak Ridge Conference 719
9.5.179 Apr 18, 2012: Cytomedix Announces Multiple Poster Presentations On AutoloGel System At
SAWC Spring 2012 720
9.5.180 Apr 18, 2012: Chembio Reports Completion Of Enrollment In Pivotal Trial For DPP HIV 1/2
Assay 720
9.5.181 Apr 18, 2012: JS Genetics Launches XCAT-FX For Fragile X Syndrome 721
9.5.182 Apr 18, 2012: AspenBio To Present Results From Recently Completed 503-Patient Pilot Study
Of AppyScore At SAEM Annual Meeting 722
9.5.183 Apr 17, 2012: QIAGEN Receives FDA Clearance For Rotor-Gene Q MDx Instrument 722
9.5.184 Apr 17, 2012: Gold Standard Diagnostics Announces Global Launch Of New, Fully Automated
ELISA Platform ThunderBolt 723
9.5.185 Apr 16, 2012: MicroPhage Receives Additional FDA 510(k) Clearance For KeyPath
MRSA/MSSA Blood Culture Test-BT 723
9.5.186 Apr 10, 2012: GeneTex Launches Monoclonal Antibody To Detect CA IX Cancer Biomarker 724
9.5.187 Apr 05, 2012: Diatron Receives FDA 510(k) Clearance For Abacus 5 724
9.5.188 Apr 04, 2012: FDA Sets Date For Advisory Committee On Review Of OraQuick Rapid HIV-1/2
Test 725
9.5.189 Apr 02, 2012: CardioDx To Present At 11th Annual Needham Healthcare Conference 725
9.5.190 Mar 30, 2012: Transgenomic Presents Results From 448-Gene NuclearMitome Test In 78
Patients At 2012 Annual Meeting Of ACMG 725
9.5.191 Mar 29, 2012: Life Technologies Receives ‗red dot‘ Award For Ion Proton Sequencer 726
9.5.192 Mar 28, 2012: PositiveID Receives Nucleic Acids From CDC Influenza Division To Develop
Diagnostic Assay To Detect H5N1 Avian Flu 727
9.5.193 Mar 28, 2012: Ortho-Clinical Announces Availability Of Avioq HTLV-I/II Microelisa System
Assay 728
9.5.194 Mar 27, 2012: BD And FIND Extend Pricing Agreement To Reach HIV-Positive Patients In
India 728
9.5.195 Mar 27, 2012: Ambry Genetics Introduces First-Step Exome Sequencing Test 729
9.5.196 Mar 27, 2012: Avioq Receives FDA Approval For HTLV-I/II Microelisa System 729
9.5.197 Mar 26, 2012: Ariosa Diagnostics Announces Completion Of Laboratory-Developed Test Study
For Harmony Prenatal Test 730
SAMPLE
Table of Contents
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 30
9.5.198 Mar 22, 2012: Quidel Receives FDA Clearance For Its Quidel Molecular Influenza A+B Assay
For Use With Cepheid SmartCycler 731
9.5.199 Mar 21, 2012: New Studies Demonstrate Clinical Utility And Validity Of CancerType ID
Molecular Classifier 731
9.5.200 Mar 21, 2012: Investigational Study May Help Researchers Develop Test That Predicts Risk Of
Imminent Heart Attacks 732
9.5.201 Mar 20, 2012: PositiveID Receives US Patent For Its Dragonfly Rapid MDx Cartridge-Based
Diagnostic System 733
9.5.202 Mar 19, 2012: diaDexus Highlights Findings From Two Outcomes Studies For Its PLAC Lp-
PLA(2) Activity Assay 733
9.5.203 Mar 19, 2012: Diagnostic BioSystems Launches First Automated IHC Multiplex Platform For
Anatomic Pathology 734
9.5.204 Mar 19, 2012: MagnaBioSciences Receives FDA 510(k) Clearance For MICT Instrument 734
9.5.205 Mar 15, 2012: Atherotech‘s VAP Cholesterol Test Helps Researchers To Study Dyslipidemia,
Assess Effectiveness Of New Anti-Flushing Agent 735
9.5.206 Mar 15, 2012: Quest Diagnostics Launches First Molecular Test For Kidney Organ Transplant
Rejection 735
9.5.207 Mar 15, 2012: Quest Diagnostics Launches Renal Monitoring Blood Test For Kidney Organ
Transplant Rejection 736
9.5.208 Mar 13, 2012: Maine Receives FDA Clearance For VALIDATE VIT D Calibration Verification /
Linearity Test Kit 737
9.5.209 Mar 13, 2012: Enzo Biochem‘s Clinical Laboratory Applies For NY State Health Department
Approval For First Assay Based On Its AmpiProbe Amplification Platform 738
9.5.210 Mar 09, 2012: Daxor Announces Filing Of Two Additional Patents For Updated Automated
Blood Analyzer 738
9.5.211 Mar 08, 2012: EKF Receives US Patent For HemoPoint H2 Cuvettes 739
9.5.212 Mar 07, 2012: Illumina Introduces TruSeq Amplicon-Cancer Panel For MiSeq System 740
9.5.213 Mar 06, 2012: Miraculins Outlines Details Of PreVu 510(k) FDA Clearance 740
9.5.214 Feb 28, 2012: Study Demonstrates AspenBio Pharma‘s AppyScore Multi-Marker Blood Test
Highly Predictive For Absence Of Acute Appendicitis In Children With Abdominal Pain 742
9.5.215 Feb 24, 2012: Natera To Present Update About Development, Commercialization Of Non-
Invasive Prenatal Diagnostic Test At Citi 2012 Global Health Care Conference 742
9.5.216 Feb 23, 2012: Abbott Collaborates With University of North Texas Science Center On Human
Identification Testing 743
9.5.217 Feb 16, 2012: Bioline Introduces New SensiFAST HRM Kit For Gene Mutations And SNP
Analysis 744
9.5.218 Feb 14, 2012: IrriMax Receives Supply Contract From Premier healthcare alliance For IrriSept
Wound Debridement And Cleansing System 744
9.5.219 Feb 14, 2012: Agilent Technologies Extends Target-Enrichment Platform To Desktop
Sequencers 745
9.5.220 Feb 13, 2012: Verinata Health Announces Presentation And Publication Of Top-Line Clinical
Validation Study Results For Its verifi Non-Invasive Prenatal Test 745
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9.5.221 Feb 06, 2012: Aria Diagnostics Announces Name Of New Non-Invasive Prenatal Assay -
Harmony Prenatal Test - And Publication Of Study On Specimen Transport 746
9.5.222 Feb 03, 2012: Natera To Disclose Details Of Non-Invasive Prenatal Diagnostic At Society for
Maternal-Fetal Medicine‘s 32nd Annual Meeting In Dallas 747
9.5.223 Feb 03, 2012: Siemens Automated Mycophenolic Acid Test On Dimension Systems Now
Available In US 747
9.5.224 Feb 02, 2012: Study Published In Genetics In Medicine Demonstrates Sequenom CMM
MaterniT21 Test Accurately Detects Two Additional Fetal Trisomies 748
9.5.225 Feb 01, 2012: Daxor Signs Trial Agreement With Shertech Pharmacy In South Carolina For
Blood Volume Analyzer-100 749
9.5.226 Feb 01, 2012: AspenBio Sets 2012 AppyScore Anticipated Milestones; Sees Pivotal Clinical
Trial For Appendicitis Test Beginning Mid-2012 749
9.5.227 Feb 01, 2012: Miraculins Receives Health Canada Approval To Market For PreVu POC Test
751
9.5.228 Jan 31, 2012: Biomerica Launches New Patented TPMT Test to Identify Individuals At Risk Of
Developing Severe Side Effects From Thiopurine Drugs 751
9.5.229 Jan 27, 2012: New Data Publication In AJOG Highlights Algorithm For Aria's Non-Invasive
Prenatal Assay 752
9.5.230 Jan 26, 2012: Aria Diagnostics Announces Publication Of Independent Study Of Its Non-
Invasive Prenatal Test In American Journal of Obstetrics & Gynecology 753
9.5.231 Jan 26, 2012: BioReference To Launch OnkoMatch Genotype Test Through Its GenPath
Oncology Laboratory 753
9.5.232 Jan 26, 2012: Study: VAP Comprehensive Cholesterol Test Improves Identification Of CIMT
Progression 754
9.5.233 Jan 25, 2012: Fenwal Receives New Regulatory Clearances For Amicus Separator And DXT
Relay Software 755
9.5.234 Jan 19, 2012: Ambry Genetics Reports Results From Clinical Diagnostic Exome Testing Of
Three Patients 756
9.5.235 Jan 17, 2012: Study: VAP Comprehensive Cholesterol Test Improves Outcomes, Reduces
Costs By 35% For Managed Care 756
9.5.236 Jan 11, 2012: Genetic Sudden Cardiac Death Screening Test On Horizon: GnuBIO 757
9.5.237 Jan 10, 2012: Life Technologies Unveils Benchtop Ion Proton Sequencer 758
9.5.238 Jan 10, 2012: Illumina Introduces HiSeq 2500 759
9.5.239 Jan 09, 2012: Aria Diagnostics Announces Publication Of First Peer-Reviewed Data For New
Non-Invasive Prenatal Test 760
10 Appendix 761
10.1 Definitions of Markets Covered in the Report 762
10.1.1 In Vitro Diagnostics 762
10.2 Research Methodology 773
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10.3 Secondary Research 773
10.4 Primary Research 774
10.5 Models 774
10.6 Forecasts 775
10.7 Expert Panels 775
10.8 GlobalData Consulting 775
10.9 Currency Conversion 775
10.10 Disclaimer 775
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1.1 List of Tables
Table 1: In Vitro Diagnostics, Cross Country Comparison, Revenue ($m),USD Constant, 2004-2018 ........................... 44
Table 2: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018 ................................... 46
Table 3: In Vitro Diagnostics, North America, Cross-Category Analysis, 2004-2018 .......................................................... 48
Table 4: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .................... 50
Table 5: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, Forecast, 2011-2018.................. 52
Table 6: In Vitro Diagnostics, North America, Company share by Revenue ($m), USD Constant, 2010-2011 .............. 54
Table 7: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 ..................................... 56
Table 8: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ..................... 58
Table 9: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ................... 60
Table 10: Clinical Chemistry, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............. 61
Table 11: Genetic Testing, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ................. 61
Table 12: Haematology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ..................... 62
Table 13: Histology And Cytology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ... 62
Table 14: Immuno Chemistry, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ........... 63
Table 15: Infectious Immunology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ..... 63
Table 16: Microbiology Culture, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ........ 64
Table 17: In Vitro Diagnostics, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ............. 66
Table 18: Clinical Chemistry, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ................ 67
Table 19: Genetic Testing, United States, Company Share by Revenue ($m), USD Constant, 2010-2011.................... 69
Table 20: Haematology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ........................ 71
Table 21: Immuno Chemistry, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 .............. 73
Table 22: Infectious Immunology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ........ 75
Table 23: Microbiology Culture, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ........... 77
Table 24: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, 2004-2018 ............................................ 79
Table 25: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ............................. 81
Table 26: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ........................... 83
Table 27: Clinical Chemistry, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ....................... 84
Table 28: Genetic Testing, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011........................... 84
Table 29: Haematology, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............................... 85
Table 30: Histology And Cytology, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............. 85
Table 31: Immuno Chemistry, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ..................... 86
Table 32: Infectious Immunology, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............... 86
Table 33: Microbiology Culture, Canada, Distribution Share by Revenue ($m), USD Constant, 2010-2011 .................. 87
Table 34: In Vitro Diagnostics, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ....................... 89
Table 35: Clinical Chemistry, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ......................... 91
Table 36: Genetic Testing, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ............................. 93
Table 37: Haematology, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 .................................. 95
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Table 38: Histology And Cytology, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ................ 97
Table 39: Immuno Chemistry, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ........................ 99
Table 40: Infectious Immunology, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011................ 101
Table 41: Microbiology Culture, Canada, Company Share by Revenue ($m), USD Constant, 2010-2011 ................... 103
Table 42: Clinical Chemisty Market Pipeline Products ........................................................................................................... 119
Table 43: Immuno Chemistry Market Pipeline Products ......................................................................................................... 126
Table 44: Haematology Market Pipeline Products .................................................................................................................. 137
Table 45: Infectious Immunology Market Pipeline Products .................................................................................................. 139
Table 46: Microbiology Culture Market Pipeline Products ...................................................................................................... 146
Table 47: Histology And Cytology Market Pipeline Products ................................................................................................. 148
Table 48: Genetic Testing Market Pipeline Products .............................................................................................................. 149
Table 49: SQI Diagnostics Plans For Sale Of The Company ............................................................................................... 154
Table 50: Sparton Completes Acquisition Of Onyx EMS, Contract Manufacturing Services Provider, For $43 Million .................................................................................................................................................................................................... 155
Table 51: ERBA Diagnostics Acquires Drew Scientific, Maker Of Analytical Instruments And Reagents, For $6.5 Million ......................................................................................................................................................................................... 157
Table 52: Measurement Specialties Acquires Cambridge Technologies And Resistance Temperature Detector Company For $18.8 Million ..................................................................................................................................................... 159
Table 53: Atossa Genetics Acquires Acueity Healthcare, Diagnostic Device Provider ..................................................... 160
Table 54: AccelPath Acquires DigiPath Solutions For $2.4 Million ...................................................................................... 161
Table 55: Danaher Completes Acquisition Of 91.6% Stake In Iris International, Diagnostic Test Maker, For $324 Million ......................................................................................................................................................................................... 162
Table 56: Charles River Labs Acquires Accugenix, Provider Of Microbe Identification Services, For $17 Million ....... 164
Table 57: Leica Biosystems Completes Acquisition Of Aperio Technologies .................................................................... 166
Table 58: Metabolon Acquires Lipomics Technologies, Diagnostics Company ................................................................. 169
Table 59: Waters Acquires Blue Reference, Maker Of Application Scientific Databases, For $14 Million ................... 171
Table 60: Life Technologies Acquires Pinpoint Genomics, Molecular Diagnostics Company ......................................... 172
Table 61: Thermo Fisher Scientific Completes Acquisition Of One Lambda, Transplant Diagnostics Company, For $925 Million ............................................................................................................................................................................... 173
Table 62: Life Technologies Acquires Navigenics .................................................................................................................. 175
Table 63: Genova Diagnostics Acquires Metametrix, Clinical Laboratory .......................................................................... 177
Table 64: 23andMe Acquires CureTogether, Healthcare IT Company ............................................................................... 178
Table 65: Luminex To Acquire GenturaDx, Molecular Diagnostics Company, For $50 Million ....................................... 179
Table 66: Systagenix Acquires O2 Insights ............................................................................................................................. 181
Table 67: Maxxam Analytics Acquires Becquerel Labs, Provider Of Testing Services .................................................... 182
Table 68: LabCorp Completes Acquisition Of Medtox Scientific For $241 Million ............................................................. 183
Table 69: Flagship Biosciences Acquires Ihctech, Provider Of Research Immunohistochemistry And Histology Services ..................................................................................................................................................................................... 185
Table 70: Halo Healthcare Acquires NeoMatrix, Maker Of Diagnostic Equipments .......................................................... 186
Table 71: Pacepartners To Acquire Vivione BioSciences ..................................................................................................... 187
Table 72: Qiagen Acquires AmniSure International, Manufacturer Of Non Invasive Test Solutions .............................. 188
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Table 73: Hologic Completes Acquisition Of Gen-Probe For $3.7 Billion ........................................................................... 189
Table 74: Haemonetics To Acquire Hemerus Medical, Provider Of Leukoreduction Technologies, For $27 Million .... 192
Table 75: IntegenX Acquires SV, Provider Of DNA Identification Consumable Products, From GE Healthcare Bio-Sciences .................................................................................................................................................................................... 194
Table 76: Beckman Coulter Acquires Blue Ocean Biomedical From Npe Systems .......................................................... 195
Table 77: Abcam Completes Acquisition Of Epitomics, Rabbit Monoclonal Antibodies Provider, For $155 Million ..... 196
Table 78: Ontario Genomics Institute Acquires Minority Stake In RNA Diagnostics For $0.1 Million ............................. 198
Table 79: PhotoVoltaic Solar Cells Acquires MetaStat, Life Science Company ................................................................ 199
Table 80: Alere To Acquire eScreen, Provider Of Health Testing Products And Services, For Up To $340 Million ..... 200
Table 81: Bode Technology Group Acquires Provider Of DNA Analysis Testing Services, Chromosomal Labs ......... 202
Table 82: Signal Genetics To Acquire Molecular Diagnostics Company, ChipDX ............................................................ 203
Table 83: Multiple Myeloma Research Foundation Enters Into Co-Development Agreement With GenoSpace .......... 204
Table 84: Empire Genomics Enters Into Licensing Agreement With Emory University For Genomic Biomarkers ....... 205
Table 85: NanoPass Technologies Enters Into Licensing Agreement With Janssen Pharma For MicronJet ................ 206
Table 86: Cisbio Bioassays Enters Into Distribution Agreement With BellBrook Labs For Transcreener Epigen Methyltransferase Assay ......................................................................................................................................................... 207
Table 87: BioView Enters Into Agreement With Abbott To Develop Automated Cancer Screening System ................. 209
Table 88: Institute of Microelectronics Enters Into Co-Development Agreement With SFC Fluidics .............................. 210
Table 89: HTG Molecular Diagnostics Enters Into Licensing Agreement With Centre of Excellence for Prevention of Organ Failure For COPD Prognostic Test ............................................................................................................................ 211
Table 90: Pressure BioSciences Enters Into Co-Marketing Agreement With Constant Systems For High Pressure Technologies ............................................................................................................................................................................ 212
Table 91: CML HealthCare Enters Into Licensing Agreement With Mitomics For Prostate Cancer Test ....................... 214
Table 92: bioMerieux Enters Into Licensing Agreement With Quanterix For Simoa Technology .................................... 215
Table 93: DioGenix Enters Into Agreement With Fast Forward To Develop New Blood Test For Multiple Sclerosis .. 217
Table 94: GNS Healthcare Enters Into Agreement With Dana-Farber Cancer Institute and Mount Sinai School of Medicine .................................................................................................................................................................................... 219
Table 95: Crown Bioscience Enters Into Co-Development Agreement With Horizon Discovery ..................................... 221
Table 96: CombiMatrix Enters Into Co-Marketing Agreement With Pathology For Prenatal Tests ................................. 222
Table 97: Clinical Genomics Enters Into Licensing Agreement With Quest Diagnostics For Colon Cancer Markers .. 223
Table 98: Abaxis Enters Into Distribution Agreement With Abbott Point of Care For Piccolo Blood Chemistry System .................................................................................................................................................................................................... 224
Table 99: Affinity Biosensors Enters Into Distribution Agreement With Malvern Instruments For Archimedes Particle Metrology System .................................................................................................................................................................... 226
Table 100: Malvern Instruments Enters Into Co-Marketing Agreement With Affinity Biosensors For Archimedes Particle Metrology System ...................................................................................................................................................... 227
Table 101: Exosome Diagnostics Enters Into Co-Development Agreement With Promega For Urine Clinical Sample Concentrator Kit ....................................................................................................................................................................... 228
Table 102: Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ ....................................... 229
Table 103: Ezose Enters Into Co-Development Agreement With Fast Forward For Multiple Sclerosis Biomarkers .... 230
Table 104: BioDot Enters Into Co-Marketing Agreement With JOT Automation ................................................................ 231
Table 105: Sequella Enters Into Licensing Agreement With LabCorp For B-Smart Technology .................................... 232
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Table 106: LifeTech Scientific, DiNova Venture Partners, Themes Investment Partners And Broncus Technologies Partner To Form Broncus Medical ......................................................................................................................................... 233
Table 107: Van Andel Institute Enters Into Co-Development Agreement With Emory University ................................... 235
Table 108: Merck Serono Enters Into Co-Development Agreement With Auxogyn For Early Embryo Viability Assessment Test ...................................................................................................................................................................... 236
Table 109: PGXL Labs Enters Into Joint Venture Agreement With Essential Molecular Testing .................................... 237
Table 110: Broad Institute Enters Into Distribution Agreement With Appistry For Genome Analysis Toolkit ................ 238
Table 111: Thermo Fisher Enters Into Co-Development Agreement With Immundiagnostik ........................................... 239
Table 112: Sage Labs Enters Into Agreement With Ekam Imaging To Develop Imaging Assays .................................. 240
Table 113: Bruker Enters Into An Agreement With Nextval For High-throughput Screening Technology ..................... 241
Table 114: BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays ............... 242
Table 115: RainDance Technologies Enters Into Co-Development Agreement With Integrated DNA Technologies For Digital PCR ............................................................................................................................................................................... 243
Table 116: Amarantus BioSciences Enters Into Option For Licensing Agreement With Memory Dx For LymPro Blood Test ............................................................................................................................................................................................ 245
Table 117: Iverson Genetic Diagnostics Enters Into Licensing Agreement With Johns Hopkins University School For Molecular Diagnostic Tests .................................................................................................................................................... 246
Table 118: Rosetta Genomics Amends Co-Marketing Agreement With Precision Therapeutics For miRview mets2 Assays ....................................................................................................................................................................................... 247
Table 119: Mitomics Enters Into Co-Marketing Agreement With LabCorp For Prostate Core Mitomic Test ................. 248
Table 120: Trillium Diagnostics Enters Into Licensing Agreement With Leukocare For Sepsis Dx ................................ 250
Table 121: Foundation Medicine Enters Into Agreement With Eisai For Genomic Profiling And Diagnostic Discovery .................................................................................................................................................................................................... 251
Table 122: Vela Diagnostics Enters Into Licensing Agreement With Life Technologies ................................................... 252
Table 123: Augurex Life Sciences Enters Into Licensing Agreement With Quest Diagnostics For 14-3-3n Biomarker .................................................................................................................................................................................................... 253
Table 124: CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital Microscopy Hematology Solutions ............................................................................................................................................................. 254
Table 125: Ingenuity Systems Enters Into Co-Development Agreement With Life Technologies For Diagnostic Solutions .................................................................................................................................................................................... 256
Table 126: Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx Test ..... 258
Table 127: Genia Technologies Enters Into Co-Development Agreement With Columbia University And Harvard University................................................................................................................................................................................... 260
Table 128: NextBio Enters Into Agreement With Winship Cancer Institute of Emory University For Myeloma Biomarkers ................................................................................................................................................................................ 262
Table 129: Proof Centre Enters Into Co-Development Agreement With AllerGen For Allergy Biomarkers ................... 263
Table 130: Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology ......................... 264
Table 131: Atossa Enters Into Co-Marketing Agreement With Diagnostics Test Group For MASCT System .............. 265
Table 132: Genalyte Partners Scienion To Provide Sciflexarrayer Dispensers For Maverick Detection Platform ........ 266
Table 133: CML HealthCare Enters Into Agreement With MaRS Innovation ..................................................................... 267
Table 134: Life Technologies Enters Into Agreement With Bristol-Myers Squibb For Companion Diagnostics Development ............................................................................................................................................................................. 268
Table 135: Agilent Technologies Enters Into Co-Marketing Agreement With Molecular Discovery ................................ 269
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Table 136: Agilent Technologies Enters Into Co-Marketing Agreement With MRM Proteomics ..................................... 270
Table 137: Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For Mesothelioma Test .................................................................................................................................................................. 271
Table 138: Illumina Enters Into Technology Integration Agreement With Partners HealthCare System ........................ 272
Table 139: Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array Products .... 274
Table 140: ImaginAb Enters Into Co-Development Agreement With MacroGenics .......................................................... 275
Table 141: BellBrook Labs Enters Into Co-Development Agreement With Reaction Biology .......................................... 276
Table 142: GVK Biosciences Enters Into Licensing Agreement With National Cancer Institute For GOBIOM Database .................................................................................................................................................................................................... 277
Table 143: GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina ................... 278
Table 144: Perkinelmer Enters Into Co-Development Agreement With Massachusetts General Hospital .................... 279
Table 145: Affymetrix Enters Into Co-Development Agreement With Pathgen Dx ............................................................ 281
Table 146: Axela Enters Into Co-Marketing Agreement With OvaGene Oncology ........................................................... 282
Table 147: University of Michigan Enters Into Joint Venture Agreement With International Genomics Consortium .... 283
Table 148: Regulus Therapeutics Enters Into An Agreement With Biogen Idec For Biomarkers.................................... 284
Table 149: Curetis Enters Into Licensing Agreement With Cempra For Unyvero .............................................................. 285
Table 150: Foundation Medicine Enters Into Co-Development Agreement With Clovis Oncology ................................. 286
Table 151: Saladax Biomedical Expands Co-Development Agreement With Bristol-Myers Squibb ............................... 287
Table 152: Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test ............. 288
Table 153: Waters Enters Into Co-Development Agreement With Nonlinear Dynamics .................................................. 289
Table 154: Affymetrix Expands Licensing Agreement With Siemens Healthcare For Branched DNA Technology ...... 290
Table 155: Molecular Targeting Technologies Enters Into Licensing Agreement With Medical College of Wisconsin For 99mTc-HYNIC-Duramycin ............................................................................................................................................... 291
Table 156: Rosetta Genomics Enters Into Co-Marketing Agreement With Precision Therapeutics For miRview mets2 Assays ....................................................................................................................................................................................... 292
Table 157: Bio-Rad Labs Enters Into Distribution Agreement With Myriad RBM For Multiplex Biomarker Kits ............ 294
Table 158: Gen-Probe Enters Into Co-Marketing Agreement With Life Technologies ...................................................... 295
Table 159: OriGene Technologies Enters Into Co-Development Agreement With Centre of Excellence for Prevention of Organ Failure ....................................................................................................................................................................... 296
Table 160: Siemens Healthcare Diagnostics Enters Into Distribution Agreement With Sysmex .................................... 297
Table 161: IRIS International Enters Into Distribution Agreement With Alifax .................................................................... 298
Table 162: EKF Diagnostics Enters Into Licensing Agreement With Joslin Diabetes Center .......................................... 299
Table 163: SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor ................ 301
Table 164: Clovis Oncology Enters Into Co-Development Agreement With Array BioPharma........................................ 302
Table 165: RS Medical Enters Into Distribution Agreement With Harvest Technologies .................................................. 303
Table 166: Immuno-Biological Labs Enters Into Licensing Agreement With IBL International ........................................ 304
Table 167: Sandia National Labs Plans To Enter Into Licensing Agreement For SpinDx, Medical Diagnostic Tool .... 305
Table 168: HTG Molecular Diagnostics Enters Into Licensing Agreement With Merck For Breast Cancer Marker Patent Portfolio ......................................................................................................................................................................... 306
Table 169: Genisphere Enters Into Co-Development Agreement With Lankenau Institute for Medical Research ....... 307
Table 170: WaferGen Biosystems Enters Into Agreement With Integrated DNA Technologies ...................................... 308
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Table 171: Pacgen Enters Into Distribution Agreement With Arise Biotech For Pipettes ................................................. 309
Table 172: BioView Enters Into Co-Development Agreement With ScreenCell For Circulating Tumor Cell Analysis Technology ............................................................................................................................................................................... 310
Table 173: MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test ................................ 311
Table 174: Fluxion Biosciences Enters Into Co-Development Agreement With Stanford University School of Medicine .................................................................................................................................................................................................... 313
Table 175: Merrimack Pharma Enters Into Co-Development Agreement With Cancer Treatment Centers of America .................................................................................................................................................................................................... 314
Table 176: Phenomenome Discoveries Enters Into Licensing Agreement With Polymedco For Cancer Diagnostic Test .................................................................................................................................................................................................... 315
Table 177: PlexPress Enters Into Technology Integration Agreement With Phalanx Biotech ......................................... 316
Table 178: PrimeraDx Enters Into Co-Development Agreement With Eli Lilly ................................................................... 317
Table 179: Kreatech Diagnostics Enters Into Co-Development Agreement With Oridis Biomarkers For DNA-FISH Assays ....................................................................................................................................................................................... 319
Table 180: Stratos Enters Into Co- Development Agreement With nanoMR ...................................................................... 320
Table 181: Guided Therapeutics Extends Licensing And Co-Development Agreement With Konica Minolta .............. 321
Table 182: CogState Enters Into Licensing Agreement With Merck Canada For Cognition Test ................................... 322
Table 183: Berg Pharma Enters Into Co-Development Agreement With Parkinson's Institute ........................................ 323
Table 184: Courtagen Life Sciences Enters Into Licensing Agreement With Scienion For sciFlexArrayer Technology .................................................................................................................................................................................................... 324
Table 185: NicOx Enters Into Licensing Agreement With Rapid Pathogen Screening For AdenoPlus .......................... 325
Table 186: Leica Microsystems Enters Into Integration Agreement With Indica Labs ...................................................... 327
Table 187: Prolias Technologies Enters Into Licensing Agreement With Cornell University For microRNA Diagnostic Portfolio ..................................................................................................................................................................................... 328
Table 188: Epigenomics Enters Into Licensing Agreement With Companion Dx Reference Lab For Septin9 Biomaker .................................................................................................................................................................................................... 329
Table 189: Immunexpress Enters Into Licensing Agreement With Debiopharm And Biocartis ....................................... 330
Table 190: Asuragen Enters Into Licensing Agreement With Becton, Dickinson .............................................................. 332
Table 191: Omega Diagnostics Enters Into Licensing Agreement With Burnet Institute For CD4 POC Test ................ 333
Table 192: KineMed Enters Into Co-Development Agreement With GlaxoSmithKline ..................................................... 334
Table 193: Bruker Enters Into Research Agreement With Special Bacteriology Reference Laboratory ........................ 335
Table 194: Bruker Enters Into Research Agreement With JMI Laboratories ...................................................................... 337
Table 195: RayBiotech Enters Into Agreement With Oslo University Hospital And University of Oslo........................... 338
Table 196: Vela Diagnostics Enters Into Co-Development Agreement With Eppendorf .................................................. 340
Table 197: One Lambda Enters Into Co-Marketing Agreement With CellTrend ................................................................ 341
Table 198: ImaginAb Extends Licensing Agreement With Bzl Biologics For Imaging Prostate Specific Membrane Antigen ...................................................................................................................................................................................... 342
Table 199: Foundation Medicine Extends Co-Development Agreement With Novartis .................................................... 343
Table 200: Affymetrix Enters Into Co-Development Agreement With Massachusetts General Hospital For New Oncology Biomarker Tests ..................................................................................................................................................... 344
Table 201: Fluxion Bioscience Enters Into Technology Integration Agreement With Rubicon Genomics ..................... 345
Table 202: Exosome Diagnostics Enters Into Technology Integration Agreement With Life Technologies ................... 346
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Table 203: HTG Molecular Diagnostics Enters Into Co-Marketing Agreement With John Wayne Cancer Institute ..... 347
Table 204: Clarient Diagnostic Services Enters Into Licensing Agreement With Insight Genetics For ALK Cancer Biomarker .................................................................................................................................................................................. 348
Table 205: Ventana Medical Enters Into Licensing Agreement With German Cancer Research Center And University Hospital Heidelberg For BRAF V600E .................................................................................................................................. 349
Table 206: Affymetrix Enters Into Technology Integration Agreement With Leica Microsystems ................................... 351
Table 207: Radisens Diagnostics Enters Into Co-Development Agreement With Beckman Coulter For HDR Detection Technology ............................................................................................................................................................................... 353
Table 208: XDx Enters Into Agreement With LabCorp To Develop Lupus Flare Predictor Test ..................................... 354
Table 209: Prosolia Enters Into Licensing Agreement With AB Sciex For ORNL Analytical Technology ...................... 356
Table 210: Ventana Medical Enters Into Licensing Agreement With Gen-Probe For IP Of ERG Marker ...................... 357
Table 211: Affymetrix Enters Into Distribution Agreement With ScreenCell For Circulating Tumor Cell Technology .. 359
Table 212: Exact Sciences Expands Licensing Agreement With Mayo Clinic ................................................................... 360
Table 213: Hycor Biomedical Enters Into Distribution Agreement With Roche For KOVA ............................................... 361
Table 214: Dako Announces Licensing Agreement With Van Andel Research Institute For Cancer Diagnostic Tool . 362
Table 215: MicroFluidic Systems Enters Into Co-Development Agreement With University of Nevada ........................ 363
Table 216: KineMed Enters Into Co-Development Agreement With CHDI Foundation .................................................... 364
Table 217: ZyGem Enters Into Technology Integration Agreement With Quanta BioSciences ....................................... 365
Table 218: Pressure BioSciences Enters Into Co-Development Agreement With Leap Technologies, Vici Valco Instruments And Sage-N Research ....................................................................................................................................... 366
Table 219: Islet Sciences Enters Into Licensing Agreement With Yale University For Early Beta Cell Destruction and Diabetes Diagnostic ................................................................................................................................................................. 368
Table 220: Genomic Health Enters Into Co-Development Agreement With OncoMed Pharma ...................................... 369
Table 221: Applied Microarrays Enters Into Co-Development Agreement With Sensovation For FlexiPlex Array System ....................................................................................................................................................................................... 370
Table 222: Cardinal Health Enters Into Distribution Agreement With Qiagen For Molecular Diagnostic Products....... 371
Table 223: MetaStat Enters Into Licensing Agreement With Albert Einstein College of Medicine For Metastatic Cell Technology Patents ................................................................................................................................................................. 372
Table 224: Genome Diagnostics Enters Into Co-Marketing Agreement With Qiagen For LongRange PCR Kit ........... 373
Table 225: Biofortuna Extends Co-Marketing Agreement With Abbott Labs For SSPGo ................................................ 374
Table 226: Pressure BioSciences Enters Into Licensing Agreement With Target Discovery For Pressure Cycling Technology ............................................................................................................................................................................... 375
Table 227: Ezose Sciences Enters Into Co-Development Agreement With Hirosaki University For New Cancer Biomarkers ................................................................................................................................................................................ 377
Table 228: LipoScience Enters Into Licensing Agreement With Cleveland Clinic ............................................................. 378
Table 229: GE Healthcare Enters Into Co-Development Agreement With NXT2B For Compact Cyclotron And PET Tracer System .......................................................................................................................................................................... 379
Table 230: Miraculins Enters Into Co-Marketing Agreement With Pear Healthcare Solutions For PreVu ..................... 380
Table 231: Abbott Enters Into Licensing Agreement With Stanford University For Prostate Cancer Biomarkers......... 381
Table 232: Metabolon Enters Into Co-Development Agreement With Takeda Pharma.................................................... 383
Table 233: Penn State Hershey Enters Into Co-Development Agreement With Serametrix ............................................ 384
Table 234: Sysmex Extends Distribution Agreement With Roche ....................................................................................... 385
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Table 235: Seattle Genetics And Millennium Pharma Enter Into Co-Development Agreement With Ventana Medical Systems ..................................................................................................................................................................................... 387
Table 236: Rubicon Genomics Enters Into Technology Integration Agreement With Kreatech Diagnostics ................. 389
Table 237: NexDx Enters Into Licensing Agreement With University of California For Epigenetic Biomarkers ............ 390
Table 238: Elchrom Scientific Enters Into Technology Integration Agreement With Biotium ........................................... 391
Table 239: RayBiotech Enters Into Co-Marketing Agreement With Innopsys .................................................................... 392
Table 240: BGN Technologies Enters Into Licensing Agreement With Lauren Sciences For V-Smart Technology .... 393
Table 241: Stellar Biotechnologies Enters Into Option Licensing Agreement With University of Guelph For Clostridium Difficile Technology .................................................................................................................................................................. 394
Table 242: Shimadzu Scientific Instruments Enters Into Joint Venture Agreement With University of Texas ............... 395
Table 243: Centre of Excellence for Prevention of Organ Failure Enters Into Co-Development Agreement With Adiga Life Sciences For Proteomic And Genomic Biomarkers .................................................................................................... 396
Table 244: Ridge Diagnostics Enters Into Licensing Agreement With Ameritox For MDDScore .................................... 397
Table 245: Bio-Rad Labs Extends Distribution Agreement With Luminex For MAGPIX .................................................. 398
Table 246: LabCorp Enters Into Licensing Agreement With OPKO Health For Alzheimer's Diagnostic Technology .. 400
Table 247: Accuray Enters Into Co-Development Agreement With University of Heidelberg .......................................... 402
Table 248: HTG Molecular Diagnostics Enters Into Co-Development Agreement With sanofi-aventis .......................... 403
Table 249: GenMark Diagnostics Enters Into Co-Development Agreement With Advanced Liquid Logic For Integrated Diagnostic Platform .................................................................................................................................................................. 404
Table 250: PerkinElmer Enters Into Licensing Agreement With GenMark Diagnostics For Microfluidics Patent Portfolio .................................................................................................................................................................................................... 406
Table 251: Bristol-Myers Squibb Enters Into Co-Development Agreement With Meso Scale ......................................... 408
Table 252: Applied BioCode Enters Into Licensing Agreement With Douglas Scientific For Barcoded Magnetic Beads Technology ............................................................................................................................................................................... 409
Table 253: Molecular Response Enters Into Co-Marketing Agreement With Transparent ............................................... 410
Table 254: IBM Enters Into Co-Development Agreement With Memorial Sloan-Kettering Cancer Center .................... 411
Table 255: QuantiScientifics Enters Into Co-Marketing Agreement With BioDot For A2 MicroArray System ............... 412
Table 256: INOVA Diagnostics Enters Into Licensing Agreement With AmberGen And Massachusetts General Hospital For Two Autoantigen Biomarkers ........................................................................................................................... 413
Table 257: Waters Enters Into Co-Marketing Agreement With Protea Biosciences Group For LASEI DP-1000 .......... 415
Table 258: Devicor Medical Products Enters Into Co-Marketing Agreement With Carbon Medical Technologies ....... 416
Table 259: Diomics Enters Into Licensing Agreement With University of Arizona For DNA Collection Technology .... 417
Table 260: Sage-N Research Enters Into Technology Integration Agreement With IO Informatics ................................ 418
Table 261: Mayo Medical Labs Enters Into Licensing Agreement With A&G Pharma For Progranulin Blood Test ..... 419
Table 262: Abbott Enters Into Co-Development Agreement With Genetics Lab For Molecular Assay Development .. 420
Table 263: Avedro Enters Into Option Agreement With Cleveland Clinic To License Intellectual Property Assets ...... 421
Table 264: GE Global Research Enters Into Co-Development Agreement With InDevR ................................................. 422
Table 265: Roche Enters Into Licensing Agreement With Life Technologies For PCR Technology ............................... 423
Table 266: Vital Diagnostics Enters Into Distribution Agreement With Cardinal Health .................................................... 424
Table 267: Dako Enters Into Co-Development Agreement With Amgen ............................................................................ 425
Table 268: Iverson Genetic Diagnostics Enters Into Co-Development Agreement With Vanderbilt University ............. 426
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Table 269: RedHill Biopharma Enters Into Co-Development Agreement With Quest Diagnostics To Develop MAP Test For Crohn's Disease ................................................................................................................................................................ 427
Table 270: Thermo Fisher Scientific Extends Licensing Agreement With Wako Pure Chemical Industries .................. 428
Table 271: Dolomite Centre Enters Into Co-Development Agreement With GigaGen ...................................................... 429
Table 272: Mitomics Enters Into Co-Marketing Agreement With LabMD For Prostate Core Mitomic Test .................... 430
Table 273: Fresh Start Private Management Enters Into Licensing Agreement With Glacier ......................................... 431
Table 274: IRIS Sample Processing Enters Into Distribution Agreement With Fisher HealthCare ................................. 432
Table 275: Courtagen Life Sciences Enters Into Co-Development Agreement With Tetracore ...................................... 433
Table 276: Quanterix, Beth Israel Deaconess And Forsyth Institute Enter Into Partnership To Develop Tuberculosis Test ............................................................................................................................................................................................ 434
Table 277: Avesthagen Enters Into Co-Development Agreement With CosmosID ........................................................... 436
Table 278: Siemens Healthcare Diagnostics Enters Into Co-Development Agreement With ViiV Healthcare .............. 437
Table 279: Siemens Healthcare Diagnostics Enters Into Co-Development Agreement With Tocagen .......................... 439
Table 280: Brooks Life Science Enters Into Licensing Agreement With The Scripps Research Institute ...................... 441
Table 281: SDIX Enters Into Licensing Agreement With BD Diagnostic ............................................................................. 443
Table 282: Thermo Fisher Scientific Enters Into Distribution Agreement With BellBrook Labs ....................................... 444
Table 283: DuPont Enters Into Co-Development Agreement With OligoCo ....................................................................... 445
Table 284: Genzyme Enters Into Co-Marketing Agreement With Veracyte ....................................................................... 447
Table 285: Boulder Diagnostics Enters Into Licensing Agreement With Portland State University ................................ 448
Table 286: Ventana Medical Systems Enters Into Co-Development Agreement With Bayer Pharma ........................... 449
Table 287: Pressure BioSciences Enters Into Co-Marketing Agreement With Digilab ..................................................... 451
Table 288: Agilent Technologies Enters Into Co-Development Agreement With Integrated Diagnostics ...................... 453
Table 289: Ventana Medical Systems Enters Into Co-Development Agreement With Pfizer .......................................... 454
Table 290: Ventana Medical Systems Enters Into Licensing Agreement With Cell Signaling Technology .................... 456
Table 291: Dako Enters Into Co-Development Agreement With Amgen ............................................................................ 458
Table 292: Foundation Medicine Enters Into Co-Development Agreement With Sanofi For Genetic Biomarkers And Potential Diagnostics ............................................................................................................................................................... 459
Table 293: University Of North Dakota Enters Into Licensing Agreement With NeoMatrix .............................................. 460
Table 294: Amorfix Life Sciences Enters Into Licensing Agreement With JSW-Lifesciences .......................................... 461
Table 295: Syndax Pharma Enters Into Co-Development Agreement With Ventana Medical Systems ........................ 462
Table 296: ZyGEM Enters Into Co-Development Agreement With USAMRIID ................................................................. 464
Table 297: AEterna Zentaris Enters Into Co-Development Agreement With Ventana Medical Systems ....................... 465
Table 298: Boulder Diagnostics Enters Into Licensing Agreement With RUNMC ............................................................. 467
Table 299: HistoRx Enters Into Licensing Agreement With Yale University ....................................................................... 468
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
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1.2 List of Figures
Figure 1: In Vitro Diagnostics, Cross Country Comparison, Revenue ($m), USD Constant, 2004-2018 ......................... 44
Figure 2: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018 .................................. 45
Figure 3: In Vitro Diagnostics, North America, Cross-Category Analysis, 2004-2018 ........................................................ 47
Figure 4: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .................. 49
Figure 5: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ................ 51
Figure 6: In Vitro Diagnostics, North America, Company share (%), 2011 ........................................................................... 53
Figure 7: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 ................................... 55
Figure 8: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .................... 57
Figure 9: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 .................. 59
Figure 10: In Vitro Diagnostics, United States, Company Share (%), 2011.......................................................................... 65
Figure 11: Clinical Chemistry, United States, Company Share (%), 2011 ............................................................................ 67
Figure 12: Genetic Testing, United States, Company Share (%), 2011 ................................................................................ 68
Figure 13: Haematology, United States, Company Share (%), 2011 .................................................................................... 70
Figure 14: Immuno Chemistry, United States, Company Share (%), 2011 .......................................................................... 72
Figure 15: Infectious Immunology, United States, Company Share (%), 2011 .................................................................... 74
Figure 16: Microbiology Culture, United States, Company Share (%), 2011........................................................................ 76
Figure 17: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, 2004-2018 ........................................... 78
Figure 18: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ............................ 80
Figure 19: In Vitro Diagnostics, Canada, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ......................... 82
Figure 20: In Vitro Diagnostics, Canada, Company Share (%), 2011 ................................................................................... 88
Figure 21: Clinical Chemistry, Canada, Company Share (%), 2011 ...................................................................................... 90
Figure 22: Genetic Testing, Canada, Company Share (%), 2011 .......................................................................................... 92
Figure 23: Haematology, Canada, Company Share (%), 2011 .............................................................................................. 94
Figure 24: Histology And Cytology, Canada, Company Share (%), 2011 ............................................................................. 96
Figure 25: Immuno Chemistry, Canada, Company Share (%), 2011 .................................................................................... 98
Figure 26: Infectious Immunology, Canada, Company Share (%), 2011 ............................................................................ 100
Figure 27: Microbiology Culture, Canada, Company Share (%), 2011 ............................................................................... 102
Figure 28: Siemens Healthcare, Company Share (%), North America In Vitro Diagnostics Market, 2011 .................... 104
Figure 29: Abbott Laboratories, Company Share (%),North America In Vitro Diagnostics Market, 2011 ...................... 105
Figure 30: F. Hoffmann-La Roche Ltd., Company Share (%),North America In Vitro Diagnostics Market, 2011 ......... 106
Figure 31: F. Hoffmann-La Roche Ltd., Company Share (%),North America In Vitro Diagnostics Market, 2011 ......... 107
Figure 32: Ortho-Clinical Diagnostics Inc., Company Share (%),North America In Vitro Diagnostics Market, 2011 .... 108
Figure 33: Alere Inc, Company Share (%),North America In Vitro Diagnostics Market, 2011 ......................................... 109
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Introduction
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 43
2 Introduction
GlobalData‘s medical equipment market reports are ideal guide for anyone wishing to understand
their market better in terms of revenue, distribution share and company share.
2.1 What is This Report About?
North America diagnostic imaging report provides an overview and the following information:
1. Comprehensive data related to the market revenue, distribution share and company share
2. Global corporate-level profiles of key companies operating in the diagnostic imaging
market in North America. The profile includes a brief overview of the company. The
selection of the companies is based on their operational presence in North America. This
includes key multinationals as well as key local players.
3. A list of key products under development by different companies. The selection of this list
is based on the territory in which these products are being clinically investigated.
Note: ―North America;‖ comprises the following countries – United States and Canada.
SAMPLE
North America In Vitro Diagnostics
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
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3 In Vitro Diagnostics in North America
3.1 In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018
Figure 1: In Vitro Diagnostics, Cross Country Comparison, Revenue ($m), USD Constant, 2004-
2018
Source: GlobalData
Table 1: In Vitro Diagnostics, Cross Country Comparison, Revenue ($m),USD Constant, 2004-2018
Country Name 2004 2011 2018 CAGR 04-11 CAGR 11-18 CAGR 04-18
Source: GlobalData
SAMPLE
North America In Vitro Diagnostics
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
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3.2 In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018
Figure 2: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018
Source: GlobalData
SAMPLE
North America In Vitro Diagnostics
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 46
Table 2: In Vitro Diagnostics, North America, Overall Revenue ($m), USD Constant, 2004-2018
Category 2004 2011 2018 CAGR 04-11 CAGR 11-18 CAGR 04-18
Source: GlobalData
SAMPLE
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North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME0193RDB / Published December 2012
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10 Appendix
The data and analysis within this report is driven by Medical eTrack
Medical eTrack gives you the key information to drive sales, investment and deal making activity in
your business. It includes the following information:
15,000+ Market size data tables across 740 medical equipment segments and 39 countries with
historic data from 2004 forecast to 2018
6,000+ Primary expert interviews conducted per annum for ensuring data and report quality
1,100+ Conferences on medical equipment covered
1,000+ Industry leading reports per annum covering growing sectors, market trends, investment
opportunities and competitive landscape
600+ Analysis reports covering market and pipeline product analysis reports by indication, medical
equipment trends and issue reports and investment and M&A trend reports worth over $3 Million
43,000+ Medical equipment companies profiled
1,500+ Private, emerging and technology start-up company profiles
1,500+ Medical equipment manufacturers in China and India
1,500+ Medical equipment companies in Japan
700+ Companies with revenue splits and market shares by category
1,500+ Quarterly and annual medical equipment company financials
700+ Medical equipment company SWOT‘s
9,000+ Pipeline product profiles
8,000+ Marketed product profiles
14,000+ Clinical trials
15,000+ Trial investigators
13,000+ New product patents
3,300+ Companies with products in development
17,000+ Deals in the medical equipment industry
1,100+ Surgical and diagnostic procedures by therapy area
40+ Key healthcare indicators by country
o For more information or to receive a free demo of the service visit
http://www.medicaletrack.com/contactus.aspx?RD=Demo=
SAMPLE
Appendix
North America In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology,
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10.1 Definitions of Markets Covered in the Report
10.1.1 In Vitro Diagnostics
In Vitro Diagnostics (IVD) include reagents, instruments and systems intended for use in the
diagnosis of disease or other conditions, including the determination of the state of health, in order
to treat or prevent disease. Such reagents, instruments and systems are intended for use in the
collection, preparation and examination of specimens taken from the human body. The categories
tracked under this market are clinical chemistry, immunochemistry, haematology, histology &
cytology, infectious immunology, microbiology culture and genetic testing. In this market only
values have been tracked.
10.1.1.1 Clinical Chemistry
Clinical chemistry includes reagents, test kits and devices that determine the concentration or
activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecules in easily-collected
bodily fluids such as blood, serum, plasma or urine. Immuno chemical reagents are not included
under this category and are tracked separately under Immuno chemistry. This category comprises
of reagents for enzyme chemistry, metabolite chemistry and electrolyte chemistry. Rapid tests for
all enzymes, metabolites and electrolyte analysis and instruments used for clinical chemistry
diagnosis are also covered in this category.
Clinical Chemistry Rapid Tests & POC
Clinical chemistry rapid tests provide the test results immediately. These tests are used in low
resource settings with the help of test strips, tablets and solutions. Clinical chemistry PoC
diagnostics are used to determine the concentration or activity of blood gas, electrolytes,
metabolites, enzymes, carbohydrates, proteins, lipids and small molecules. These tests are
performed for the analysis of body fluids such as blood, serum, sputum, urine, feces and others.
Blood glucose testing is not tracked in this segment.
Clinical Chemisty Analyzers
Clinical chemistry analyzers are instruments used to perform tests relating to enzyme chemistry,
metabolite chemistry and electrolyte chemistry. Clinical chemistry analyzers can be fully
automated or semi automated.
Automated Clinical Chemistry Analyzers
A fully automated clinical chemistry analyzer is connected to a software program that allows the
user to feed in most test parameters. The tasks associated with performing the test like dispensing
the reagents and incubation are automated and require minimum manual work.
Semi-Automated Clinical Chemistry Analyzers
A semi-automated clinical chemistry analyzer requires an operator to perform the reagent
dispensing, incubation and other tasks manually.
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Electrolyte Chemistry Reagents
Reagents used to quantify or detect electrolytes to detect bodily functions and disease states.
Examples of electrolytes tracked include sodium, potassium, chloride, bicarbonate, magnesium,
calcium etc from the extra cellular fluids of the body.
Enzyme Chemistry Reagents
Reagents and test kits used for quantification and detection of enzymes that act as a marker for
identification and determination of disease states and bodily functions. Examples of enzymes
tracked include acid phosphatase, alkaline phosphatase, creatine kinase lactate dehydrogenase
etc.
Metabolite Chemistry Reagents
Reagents used for the quantification of metabolites for the assessment of bodily functions and
disease states. Examples of metabolites tracked are creatinine, cholesterol, triglycerides, albumin,
bilirubin etc.
Urine Analysis
Urine analysis is the analysis of urine to aid in the diagnosis of disease or to detect the presence of
a specific substance.
Urine Analyzer Reagents
Urine analyzer reagents are the reagents used in urine analyzers.
Urine Analyzers
Urine analyzers are analytical laboratory equipment used in qualitative and semi-quantitative tests
performed on a urine sample.
10.1.1.2 Genetic Testing
Genetic testing reagents are used for the identification of specific syndrome present in an
individual and can improve the accuracy of the diagnostic tests leading to a better treatment.
Reagents used to perform acquired gene or chromosome alterations, inborn gene or chromosome
alterations and other genetic tests have been tracked under this category.
Acquired Gene or Chromosome Alterations
Reagents which are used in genetic tests to detect cancer causing genes/related alterations like
p53, k-ras, BRCA 1+2 etc.
Inborn Gene or Chromosome Alterations
Genetic tests to detect monogenetic disorders (like Cystic Fibrosis, Haemochromatosis,
Prothrombin Mutation etc), polygenetic disorders (like Asthma, Atherosclerosis, Diabetes,
Hypertension, Osteoporosis, etc), chromosomal disorders (like Down's Syndrome, Edwards
Syndrome etc), polymorphisms (like HLA-Typing etc).
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Other Genetic Tests
Other genetic tests include pharmaco-genomics which include test related to cytochrome P450
(CYP 450). These tests can be by either individual tests or multiple tests which are conducted on
micro-arrays.
10.1.1.3 Haematology
Haematology includes reagents, rapid tests and instruments used for determination and diagnosis
of both physiological and pathological aspects of blood and its components. The category also
includes immune related reagents used for analysis of blood and its components.
Haematology Analyzers
Analytical laboratory equipments which are used to perform tests related to blood and its
components. These analyzers are also used to identify and determine morphology of blood and
blood-forming cells such as white blood cells, lymphocytes, monocytes, neutrophils, eosinophils
and basophils.
Haematology Cell Counters
These are blood counters used for complete blood count determination in routine examinations.
Differential Counters
These are instruments which are used in the measurement of the percentage of each type of white
blood cell of an individual. It also detects if there are any abnormal or immature cells in an
individual.
Hemoglobinometers
These are Instruments which are used for colorimetric representation of the percentage of
haemoglobin in a blood sample.
Haematology Rapid Tests
These are spot tests that generate results immediately and can be done in low resource setting.
These tests are performed to detect the Haemoglobin, Erythrocytes and Haematocrit etc
Erythrocytes (Ery)
Rapid test kits used for detecting the concentration of Erythrocytes in human blood are covered
under Erythrocytes (Ery) rapid test kits.
Haematocrit (HCT)
Rapid test kits used for detecting the concentration of Haematocrit (HCT) in human blood are
covered under Haematocrit (HCT) rapid test kits.
Haemoglobin (Hb)
Rapid test kits used for detecting the concentration of haemoglobin in human blood are covered
under Haemoglobin (Hb) rapid test kits.
Haemostasis Rapid Tests (Home Monitoring)
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These are spot tests to detect haemostasis. These include prothrombin time rapid test, D-Dimer
rapid test, activated clotting time (ACT) rapid test etc
Haematology Reagents
These are reagents that are provided for substantially lysing the red blood cells in a whole blood
sample prior to haematology analysis.
Haematology Analyzer Reagents
Haematology analyzer reagents are exclusively used in blood lysing techniques. These reagents
generally contain tris-HCl, EDTA, EGTA, SDS, deoxycholate, tritonX, etc.
Slide Stainers
Slide stainers are reagents used in the staining of slides and smears. Reagents like crystal violet,
safranin, etc have been tracked.
Haemostasis
These include test kits and reagents that are used to conduct blood coagulation related tests.
Coagulation analyzers and reagents used to conduct various coagulation tests have been tracked
under this segment.
Coagulation Analyzers
These are automated or semi automated laboratory equipments used in clotting assay,
chromogenic assay, haemostasis profile etc.
Coagulation Factors
Reagents used in the detection of the coagulation factors are covered here. These coagulation
factors such as Factor VII, VIII, IX, XII etc, are involved in the blood coagulation process.
General Coagulation Tests
Coagulation tests include INR/prothrombin time, activated partial thromboplastin time (APTT or
PTT), bleeding time, plasma thrombin time etc. These tests are useful to diagnose disease
condition such as Haemophilia, Uremia, Thrombocytopenia and Vitamin K deficiency.
Platelet Factors
These reagents are used to conduct tests in the determination of cytokines belonging to the
chemokine family.
Special Coagulation Tests
These are reagents which are used to conduct special coagulation tests which provide quantitative
determination of anticoagulant activities of heparin and thrombin formation.
Immunohaematology
Immuno haematology studies antigen-antibody reactions and analogous phenomena as they
relate to the pathogenesis and clinical manifestations of blood disorders.
ABO Typing
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These are the reagents used for detecting blood types into four categories: Type A, Type B, Type
AB and Type O.
Antibody Detection
Antibody detection is done for the differential diagnosis of many different pathological conditions.
These determinations of specific antibodies to bacterial and viral pathogens as well as to parasites
enable the correct therapeutic measures to be taken.
Rhesus Typing
These are the tests which are used to detect Rh factor (antigen) on the surface of the red blood
cells.
10.1.1.4 Histology And Cytology
These are reagent test kits and instruments used in tissue and cell typing techniques. Flow
cytometers, monoclonal antibodies and tissue typing reagents have been tracked under this
category.
Flow Cytometers
Flow cytometers are an electronic detection apparatus used in a technique for counting and
examining microscopic particles, such as cells and chromosomes, by suspending them in a stream
of fluid.
Monoclonal Antibodies
Monoclonal antibodies for cell surface antigen are antibodies from a single clone of hybridoma
cells. These are used for specific target cells which identify the tissue by the cell surface antigen.
Tissue Typing Reagents
These are the reagents which are used to determine the compatibility of tissues between a
prospective donor and a recipient prior to transplantation.
10.1.1.5 Immuno Chemistry
The immunochemistry category includes reagents, instruments and test kits used for the analysis
of antigen-antibody interactions in any of the bodily fluids. The category includes both test kits and
reagents for quantification and detection of specific proteins, hormones, drug moieties and non-
infectious diseases. Reagents and kits used in the diagnosis of infectious disease are not included
in this category.
Anemia / Vitamin Tests
Reagents used for estimation of anaemia and vitamin deficiency. These includes the reagents
used for quantitative measurement of iron, ferritin, folate and vitamin B 1, 2, 6, 12, Vitamin-D
Disease Specific Immunochemistry
Disease specific immunochemistry is an assay of specific markers of a particular disease. These
tests include assays of mostly antibodies released in response to a specific disease and also other
disease-causing proteins.
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Allergy Blood Tests
Allergy Blood test is allergen-specific IgE antibody test used to measure the amount of
immunoglobulin (Ig) E antibodies to a specific allergen in the blood. A blood test tells a physician
what type of antibodies your blood contains in order to provide information on what is causing your
allergies. The test kits or reagents used to perform allergy blood test are covered under this sub
segment.
Auto-Immune Diseases
This includes the reagents and kits used to perform tests for the diagnosis of immune system
disorders and other disease states to detect auto-antibodies, which are antibodies produced
against the body‘s own tissues. The tests are used for the diagnosis of certain autoimmune
disease such as Addison‘s disease, autoimmune pancreatitis, Celiac disease, Crohns Disease,
Diabetes mellitus type 1, etc. The kits in this sub-segment include anti-nuclear antibody (ANA) kits,
etc.
Cardiac Markers
Cardiac marker tests function to identify blood chemicals associated with myocardial infarction and
other acute coronary syndromes. The tests include assays for proteins and chemicals like Creatine
Kinase-MB (CK-MB), myoglobin, homocysteine, C-Reactive Protein (CRP), troponin T (cTnT) and
troponin I (cTnI), associated with heart diseases.
Rheumatoid - Inflammatory Diseases Markers
These are the reagents used to detect Rheumatoid – Inflammatory diseases markers. These
markers are antigen/antibodies that detect specific antigen/antibodies produced by bone, cartilage
or any other inflammatory disease activity.
Tumor markers
The reagents used in the tests that detect specific antibodies/antigen produced by the tumor itself
or by the body in response to the tumor. Some commonly detected tumor markers include CA19-9,
CA15-3, CA-125, AFP, etc. The tests can assay markers from samples of blood, urine or body
tissue.
Drugs of Abuse / Toxicology
Test kits used to determine the type and approximate amount of legal and illegal drugs a person
has taken are covered under Drugs of abuse/ Toxicology. Screening is most often done using a
blood or urine sample. This segment includes drugs of abuse and toxicology.
Drugs of Abuse
Test kits for measurement of drugs of abuse from blood, serum or urine. These are the systems
used for testing of depressants, narcotics, stimulants and hallucinogens.
Toxicology
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These are test kits for measurement of toxic substances or drugs from the blood or urine sample.
These are systems used for testing of drugs like Acetaminophene (Paracetamol), 5-
Aminolevulinate Dehydratase, Desipramine, Hippuric Acid, Phenols, Ethanol (Alcohol), etc.
Endocrinology Tests
Reagents used for quantification and detection of endocrine hormones secreted in the human
body. These include the thyroid function hormones, pregnancy hormones, individual and specified
hormones.
Fertility or Pregnancy Hormones
Pregnancy test system intended for the early detection of pregnancy by the measurement of
Human Chorionic Gonadotropin (HCG), a placental hormone, in plasma or urine.
Individual and Specified Hormones
Reagents used for a quantitative measurement of specific hormones for any purpose other than
pregnancy and thyroidal hormones are included here. They include reagents for testing of
hormones like Estrogen, Estradiol, Estriols, Adrenocorticotropic hormone, Aldosterone etc.
Thyroid Function Hormones
Reagents used for the quantification and detection of hormones secreted by the thyroid gland.
Reagents used to test TSH, T3 and T4 are included in this segment.
Immunochemistry Analyzers
Immunochemistry analyzers are analytical laboratory equipments used to perform tests for specific
proteins and therapeutic drugs. These analyzers are typically offered in modular increments, which
can operate independently or simultaneously as a unit. Analyzers covered under this category
include Chemiluminescence Analyzers, Radioimmunoassay Analyzers, Immunofluorescence
Analyzers and ELISA Instruments. Analyzers used to perform chemical analysis (enzyme,
electrolyte, metabolic or urine analysis are excluded and are covered under clinical chemistry.
Chemiluminescence Analyzers
Chemiluminescence analyzers are analytical laboratory equipments used to detect glow-based
chemiluminescent reactions. These are used for the quantitative determination of bio-molecules
such as hormones, antibodies to infectious diseases and other proteins in human serum and
Plasma.
ELISA Instruments
ELISA Instruments are used in enzyme-linked immuno sorbent assays for the diagnostic analyses
of antigens or antibodies in a solution using colorimetric signals. These instruments include micro
plate readers, ELISA washers, ELISA reader, etc.
Immunofluorescence Analyzers
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Immunofluorescence analyzers are analytical laboratory equipments used for the visualization of
sub cellular distribution antibodies or antigens of interest. Using these analyzers the bio-molecules
of interest are labelled with specific antibodies chemically conjugated with fluorescent dye.
Radioimmunoassay Analyzers
Radioimmunoassay analyzers are analytical laboratory equipments used to measure
concentrations of antigens (for example, hormone levels in the blood) using radioactive
substances without the need to use a bioassay.
Immunochemistry Rapid Tests
Spot test kits intended generally for rapid diagnosis with immediate results, through immuno
assays. Some of the tests carried out using immunochemistry rapid test include rabies virus test,
allergenic food proteins and enteric infection
Drugs of Abuse / Toxicology Rapid Tests
Rapid immunodiagnostic tests intended for immediate detection and measurement of illegal and
legal drugs a person has taken. These tests detects and measures Amphetamines,
Amphetamine/Methamphetamine Specific (+Ecstasy), Barbiturates, Benzodiazepines,
Cannabinoids, Cocaine, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressants, etc in
blood, serum and urine samples.
Fertility / Pregnancy Rapid Tests
Rapid immunodiagnostic tests intended for immediate detection of fertility / pregnancy by
measurement of Follicle-stimulating hormone (FSH), Human placental lactogen (HPL), Human
luteinizing hormone (LH) and Human chorionic gonadotropin (HCG) hormone in plasma, serum
and urine samples.
Other Immunochemistry Rapid Tests
Immunodiagnostic tests intended for the immediate detection of Individual and Specified
Hormones/Proteins, Albumin, uAlbumin, Glycosylated/Glycated Haemoglobin, Prostate-specific
antigen (PSA), Bladder tumor antigen (BTA stat), C - Reactive protein, Rheumatoid / Inflammatory
Disease protein, Creatine Kinase, Myoglobin, Troponin, BNP / proBNP, Heart-Type Fatty Acid-
Binding Protein, etc. in plasma, serum and urine samples.
Organ Function Assays
These include test systems usually carried out through blood or urine test, for evaluating the
wellness of a specific organ through an assay of the organ metabolites. These include liver
function tests, kidney function tests etc.
Specific Proteins
These are reagents and test kits which are used to quantify and detect protein molecules from
bodily fluids. Immunoglobulins (without IgE), HAMA, Immunoelectrophoresis & ImmunoFixation
Kits, Complement Components, Transport Proteins, Lipoproteins, AGP, AAT, Micro and Macro G
etc. have been tracked under this segment.
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Therapeutic Drug Monitoring
Therapeutic drug monitoring include reagents and test kits intended to measure different types of
therapeutic drugs from samples ranging from serum/blood, urine, hair and sweat. Test kits for
measurement of both proteins based and chemical based therapeutic drugs are covered. This
include tests for antibiotics, anti analgesics, anti-inflammatory, antipyretic and menstrual drugs.
Antibiotic TDM / Antivirus TDM
Therapeutic drug monitoring reagents used for the measurement of antibiotics or antivirus are
covered under antibiotic/antivirus TDM. Reagents used for detection of antibiotics like Gentamicin,
Sisomycin, Streptomycin, Netilmycin etc are covered here.
Cardiovascular TDM
Therapeutic drug monitoring reagents used for the measurement of drugs specific for
cardiovascular diseases at timed intervals in order to maintain a relatively constant concentration
of the medication in the bloodstream are covered under Cardiovascular TDM. Reagents used for
detection of cardiovascular drugs like Digoxin, Procainamide, Propranolol, Quinidine, etc are
covered here.
Central Nervous Systems TDM
Therapeutic drug monitoring reagents used for the measurement of drugs specific for central
nervous system are covered under central nervous systems TDM. Reagents used for detection of
central nervous systems drugs like Carbamazepine, Ethosuximide, Free Primodine, Valproic Acid
etc are covered here.
Immunosuppressant TDM
Therapeutic drug monitoring reagents used for the detection of immunosuppressant concentration
in human body are covered under immunosuppressant TDM. This includes reagents used for
detection of Immunosuppressant like Cyclosporin, Mycophenolate, Tacrolimus, etc.
10.1.1.6 Infectious Immunology
This category includes reagents and test kits used for the detection or quantification of infectious
agents like bacteria and viruses by using antigen-antibody (Ag – Ab) and nucleic acid tests.
Bacteriology
Reagents and test kits to detect the pathogenicity of bacteria such as chlamydia, gonococci,
syphilis, helicobacter pylori, salmonella and so on.
Hepatitis Viruses
These are diagnostic test kits which are used to detect the hepatitis virus such as HAV, HBV,
HCV, HbsAg and HXV.
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Infectious Immunology Rapid Tests
Spot test kits intended generally for rapid diagnosis with immediate results, through immuno
assays. Tests carried out using Infectious Immunology rapid test include Hepatitis Virus,
Retrovirus and Other Virology Rapid Tests.
Hepatitis Viruses Rapid Tests
Immunodiagnostic tests intended for immediate detection of HBsAg, HCV Antibody and other
Hepatitis Viruses.
Other Infectious Immunology Rapid Tests
Immunodiagnostic tests intended for immediate detection of Chlamydia Ag, H. pylori, Strep. A,
Strep. B, Syphilis, Clost. diff. including Toxin A and B, Meningitis causitive agents, Legionella,
Strep. Pneumoniae, CMV, RSV, Mononucleosis (EBV), Influenza A and/or B, VZV, Dengue,
Plasmodium (Malaria), etc.
Retroviruses Rapid Tests
Immunodiagnostic rapid tests intended for immediate detection of HIV 1, HIV 1 / 2, HIV Ag/Ab
Combi and other Retroviruses.
Other Virology
These are diagnostic test kits which are used to confirm the antigen/antibody of rubella,
cytomegalovirus, the herpes simplex virus and the Epstein Barr Virus.
Retroviruses
These are diagnostic test kits which are used to detect the antigen/antibody of HIV1, HIV 2 and
HTLV I, HTLVII.
10.1.1.7 Microbiology Culture
This category includes reagents used for the preparation of growth medium for microbial
organisms. This category also includes dehydrated and prepared culture media for micro organism
growth.
Bacterial Identification & Susceptibility Testing
This includes the reagents and test kits (manual and automated) used to identify and test the
sensitivity of bacteria towards an antimicrobial substance.
Blood Culture
Culture media used for the preparation of medium capable of supporting the growth of bacteria
and other micro organisms. It is a culture of blood, used to identify the infection of blood stream
like bacteremia, septicaemia, etc. They are generally in solid/liquid forms or only solid and liquid
forms with constituents specific to the bacteria.
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Immunological Culture Identification
Reagents used to test the streptococci grouping, meningitis, staphylococci and serotyping.
Microbiology Analyzers
These are analytical laboratory equipments used to perform routine and special microbiology tests.
These include fully automated or semi automated microbiology analyzers.
Automated Microbiology Analyzers
A fully automated analyzer is connected to a software program that allows the user to feed in most
test parameters. The tasks associated with performing the test like dispensing the reagents,
incubation etc are automated and require minimum manual work.
Semi-Automated Microbiology Analyzers
A semi-automated analyzer requires an operator to perform the reagent dispensing, incubation
and other tasks manually.
Mycobacteria Culture
It includes the culture media used for the preparation of medium capable of supporting the growth
of mycobacterium.
Mycology Culture
It includes culture media and reagents for the preparation of culture medium that is capable of
supporting the growth of fungi. These cultures are used to detect infection like dermatophyte
infections, etc
Parasitology Culture
Culture media used for the preparation of medium capable of supporting the growth of blood
parasites like plasmodium, pneumocystis etc.
Note: 1). Value, distribution and company shares figures reflect annual gross sales of in vitro
diagnostics in local currency converted to $ at constant rate. The annual growth (year on year
growth) and compounded annual growth rate (CAGR) in tables is rounded off to one decimal
place.
2). Company share data represents market share (in revenues and as percentage to total market)
of companies in market categories and geographies tracked. The data is rounded off to the
nearest decimal places.
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10.2 Research Methodology
GlobalData‘s dedicated Research and Analysis Teams consists of qualified professionals with
experience in marketing, market research, consulting background in the medical devices industry
and advanced statistical expertise.
GlobalData adheres to the Codes of Practice of the Market Research Society (www.mrs.org.uk) and
the Strategic and Competitive Intelligence Professionals (www.scip.org).
All GlobalData databases are continuously updated and revised. The following research
methodology is followed for all databases and reports.
10.3 Secondary Research
The research process begins with exhaustive secondary research on internal and external sources
being carried out to source qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations and SEC
filings;
Industry trade journals, scientific journals and other technical literature;
Internal and external proprietary databases;
Relevant patent and regulatory databases;
National government documents, statistical databases and market reports;
Procedure registries; and
News articles, press releases and web-casts specific to the companies operating in the market.
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10.4 Primary Research
GlobalData conducts thousands of interviews a year with industry participants and commentators
in order to validate its data and analysis. A typical research interview fulfills the following functions:
It provides first-hand information on market size, market trends, growth trends, competitive
landscape and future outlook;
Helps in validating and strengthening the secondary research findings; and
Further develops the analysis team‘s expertise and market understanding.
Primary research involves e-mail interactions and telephonic interviews for each market, category,
segment and sub-segment across geographies.
The participants who typically take part in such a process include, but are not limited to:
Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and
national sales managers;
Hospital stores, laboratories, pharmacies, distributors and paramedics;
Outside experts: investment bankers, valuation experts, research analysts specializing in specific
medical equipment markets; and
Key opinion leaders: physicians and surgeons specializing in different therapeutic areas
corresponding to different kinds of medical equipment.
10.5 Models
Where no hard data is available, GlobalData uses modeling and estimates in order to produce
comprehensive data sets. The following rigorous methodology is adopted:
Available hard data is cross-referenced with the following data types to produce estimates:
Demographic data on population segments;
Macro-economic indicators such as GDP, inflation rate;
Healthcare indicators such as health expenditure, physician base, healthcare infrastructure and
facilities; and
Selected epidemiological and procedure statistics.
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10.6 Forecasts
GlobalData uses proprietary forecast models. The following four factors are utilized in the forecast
models:
Historic growth rates;
Macro-indicators such as population trends and healthcare spending;
Forecast epidemiological data; and
Qualitative trend information and assumptions.
The data is then cross-checked by the expert panel.
10.7 Expert Panels
GlobalData uses a panel of experts to cross verify its databases and forecasts.
GlobalData‘s expert panel comprises marketing managers, product specialists, international sales
managers from medical device companies; academics from research universities, KOLs from
hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment
and supplies etc.
Historic data and forecasts are relayed to GlobalData‘s Expert Panel for feedback and adjusted in
accordance with their feedback.
10.8 GlobalData Consulting
We hope that the data and analysis in this brief will help you make informed and imaginative
business decisions. If you have further requirements, GlobalData‘s consulting team may be able to
help you. GlobalData offers tailor-made analytical and advisory services to drive your key strategic
decisions.
10.9 Currency Conversion
The Currency Conversion rate is based on 2011 average rate. 1 USD =
Canada 0.989 CAD.
10.10 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior
permission of the publisher, GlobalData.