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Harmony Imaging and Analysis for Cytogenetics Every Diagnosis Counts

Imaging and Analysis for Cytogenetics · *FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH HER2/neu (Breast) Hematology Enumeration ALK (Lung) Hematology

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Page 1: Imaging and Analysis for Cytogenetics · *FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH HER2/neu (Breast) Hematology Enumeration ALK (Lung) Hematology

HarmonyImaging and Analysis for Cytogenetics

EveryDiagnosisCounts

Page 2: Imaging and Analysis for Cytogenetics · *FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH HER2/neu (Breast) Hematology Enumeration ALK (Lung) Hematology

Chromosome Analysis and FISH Diagnostics

Automated workflows, digital analysis and full integration

maximize lab efficiencies

Optimized Productivity

Diagnostic Confidence

Multi Application

Superb image quality, powerful algorithms and feature rich software ensure results accuracy

A broad sample, staining and probe menu that meets the full range of Cytogenetic demands

"Harmony doubled our lab productivity in bone marrow karyotyping and tripled our productivity in blood sample karyotyping."

Nettie Rietema, University Medical Center Groningen, NL

"Harmony allows us to view much more cells than we would with a manual microscope, which leads to more accurate and reliable FISH results. Manual FISH analysis is also tedious

and leads to technologist fatigue but Harmony never gets tired."

Dr. Yarin Hadid, Bnai Zion Medical Center

Automatic Slide Scanning

Digital Karyotyping and FISH Analysis

View, Manage and Share

Page 3: Imaging and Analysis for Cytogenetics · *FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH HER2/neu (Breast) Hematology Enumeration ALK (Lung) Hematology

Uncompromising Image QualityStart & Walkaway Scanning

Feature Rich Review & Analysis

Increased Lab Productivity

Easy Separation and Boundary Editing

Advanced Onscreen Supervisor Review

High resolution 4MP camera sensor combined with a high quality 100x immersion oil objective

Broad Staining and Sample Menu

FISH

G-Band

Spectral

Q-Band

R-Band

R-Band

Free technologist time to where their expertise is needed most

“Magic Tool” combining 12 operations in a simple mouse click

Blood Bone Marrow Amniotic Fluid CVS

CountAccurate automatic

chormosome counting

Image GalleryDisplay of all case metaphases and karyotypes

AnalyzeFast and easy chromosome indexing and classification

Chromosome CompareAll captured cells and chromosomesside by side

KaryotypeEasy separation of chromosomes

and advanced image enhancement

Aberrant IdeogramChromosomes, cells, ideograms andannotations in an image generator

Digital Chromosome Analysis

Efficiency, Precision, Versatility

Traditional Karyotyping

HarmonyBone Marrow Amnio Blood

4,532

1,548

1,352

468

624

204

Overlap ExtendSplit Combine

Saves hundreds of mouse-clicks per

karyotype!

66% Technologist Time Savings (Hours / Month)

*FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH

Page 4: Imaging and Analysis for Cytogenetics · *FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH HER2/neu (Breast) Hematology Enumeration ALK (Lung) Hematology

Easy Classification & Review

Image Quality Driven to the Max! Increased Diagnostic Confidence

Workflow Efficiencies for Increasing Test Volumes

Wide Application Coverage

Any Sample

Any Probe

Digital Z-Stacking

Multi Layer Display

Signal Detection

Digital FISH DiagnosticsAccuracy, Consistency, Ease-of-Use

Over 55% Time Savings (Minutes / Case)

*FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH

HER2/neu (Breast)

Hematology Enumeration

ALK (Lung)

Hematology Fusion

UroVysion (Bladder)

“Digital FISH analysis provides more efficient and accurate results and better patient care in comparison to traditional FISH methods.”

Liew M, Rowe L, Clement PW, Miles RR, Salama ME., J Pathol Inform. 2016

AccuracyAutomated cell/ signal detection and classification for consistent reliable results

High image quality with digital Z-stack of each cell

Cell gallery for fast and easy classification review

Multi-layer view for each signal

Real time statistics

No More Dark Room!

Harmony

Manual FISH

ALK CLL AML

45

-78% -71%

-58%

10

50

21

45

13

Page 5: Imaging and Analysis for Cytogenetics · *FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH HER2/neu (Breast) Hematology Enumeration ALK (Lung) Hematology

Quality Control of Probe AssaysCell phenotyping and signal classificationMeasurment and display of multiple cellular and signal properties

Harmony for Research Applications

Circulating Tumor Cells Immuno Fluorescence

clgFISH Successive Staining

TelomeresSperm Cells

Automatic identification of translocations and chromosomal origins

Simultaneous detection of chromosomal aberrations in one hybridization

Measurement of entire spectrum at each point

Multi-Color FISH Analysis for Result Verification

Brain Tumor Ewing Sarcoma

HiSKY Probe KitChromosome paints for human, mouse and rat

HiSKYFISH Research

Gold Standard Spectral Karyotyping

MN ScoreMicronuclei imaging, scoring and analysis for measurement of DNA damage, cytostasis and cytotoxicity

Page 6: Imaging and Analysis for Cytogenetics · *FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH HER2/neu (Breast) Hematology Enumeration ALK (Lung) Hematology

Case Data Management (CDM)

GenASIs AnyWhere™ for Remote AccessLab Connectivity Anytime, Anywhere

Review, analyze and sign off case information from any location via a secured network

Data Management and ConnectivityModern Paperless Workflow

Central Portal and Database Easily Integrates with Lab LIS

LIS Connectivity

Performance

Security

Data Integrity

HIPAA Compliant

Advanced Reporting 1D/2D Barcode Reader

Efficient

Comprehensive

Eliminates human error

Remote access,review and analysis

Supervisor easy access

Director sign off from any location

GLOBAL ACCESS

User selected Fields of View

Semi Automated

High Cellular Density

User pre-configured scanning pattern and stop criteria

Fully Automated

High Cellular Density

DensityScan™ automatic detection and ranking of Fields of View

Fully Automated

Low Cellular Density

Automated WorkflowsKaryotyping and FISH in The Same Batch

Scanning Protocols for All Probes, Samples and Preparation Techniques

Fully Automated

Patient Database

Immediate Access

Automatic Barcode Reader Unattended Scanning Oil Dispenser Image Acquisition

Onscreen Analysis Advanced Supervisor Review Customized Reporting LIS Connectivity

Page 7: Imaging and Analysis for Cytogenetics · *FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK and HER2/neu FISH HER2/neu (Breast) Hematology Enumeration ALK (Lung) Hematology

www.spectral-imaging.com

North AmericaApplied Spectral Imaging Inc.Tel: +1 760 929 [email protected]

HeadquartersApplied Spectral Imaging Ltd.Tel: +1 817 886 [email protected]

Manual 1 Slide 9 Slide Motorized Stage 81 Slide Tray Loader HyperSpectral 1 Slide

Microscope Support BF and FL upright

microscopes

OLYMPUS BX61, OLYMPUS

BX63, ZEISS AxioImager Z2

OLYMPUS BX61, ZEISS

AxioImager Z2

BF and FL upright

microscopes

Objectives 10x, 60x (oil), 100x (oil) OLYMPUS:

4x, 10x, 40x, 60x (oil), 100x (oil)

ZEISS:

4x, 10x, 40x (oil), 63x (oil), 100x (oil)

OLYMPUS:

4x, 10x, 40x, 60x (oil), 100x (oil)

ZEISS:

4x, 10x, 40x (oil), 63x (oil), 100x (oil)

10x, 60x (oil), 100x (oil)

Camera 4MP Monochrome 4MP Monochrome 4MP Monochrome Spectral 1.3MP

Monochrome

Slide Capacity 1 slide (Manual or

Motorized)

9 slides 81 slides PLUS 1 slide (Manual or

Motorized)

Barcode Reader Handheld 1D/2D Handheld 1D/2D Integrated 1D/2D Handheld 1D/2D

Automated Oil Dispenser

N/A Optional Integrated N/A

Dimensions [WxDxH] 28cm x 44cm x 55cm 32cm x 54cm x 67cm 100cm x 56cm x 75cm 28cm x 44cm x 85cm

Weight 16kg 42kg 100kg 20kg

DOC000349 Rev. B