SPI Infoamtion

Table of Contents

Executive summary

Market overview
POC testing in diabetes
Fertility-related tests
Hemostasis testing
Cardiology tests
Infectious disease tests
Drugs of abuse testing
Clinical chemistry and other rapid tests
Company profiles
Market analysis and forecasts

Chapter 1 Market overview

Summary
The shift to POC diagnostic testing
Locations for POC testing
Background on IVD technologies

Clinical chemistry
Immunoassays
Nucleic acid testing

Technologies for POC testing

Lateral-flow tests

Next-generation lateral-flow devices

Electrochemical enzymatic tests
Advances in microfluidics

Data management and connectivity
Market drivers
Market restraints
Regulation of in vitro diagnostic tests (US)

CLIA

Chapter 2 POC testing in diabetes

Summary
Diabetes diagnostics and monitoring
Meter systems for blood glucose monitoring

Increasing performance requirements
Examples of POC device manufacturers

Roche Diagnostics
Arkray
Home Diagnostics
Abbott Diabetes Care
Nova Biomedical
Epocal
Diagnostic Devices
HemoCue
Luminous Medical
Health-Chem Diagnostics

Continuous glucose monitoring systems

Examples of POC device manufacturers

DexCom
Medtronic MiniMed
Abbott Diabetes Care

HbA1c testing

Examples of POC device manufacturers

Diazyme Laboratories
HemoCue
Bio-Rad Laboratories
Siemens
Trinity Biotech

Chapter 3 Fertility-related tests

Summary
Introduction
Pregnancy (hCG) tests

Detection of hCG variants

Ovulation tests
OTC pregnancy test kits

Examples of manufacturers of pregnancy tests

Inverness Medical Innovations
Swiss Precision Diagnostics
Church & Dwight
Siemens Healthcare Diagnostics
Applied DNA Technologies
Quidel
BTNX
Germaine Laboratories

Other fertility-related tests

Chapter 4 Hemostasis testing

Summary
Introduction
Hemostasis modulation

Use of anticoagulants
Use of antiplatelets

Hemostasis testing

Coagulation testing

Prothrombin time
Activated partial thromboplastin time
Activated coagulation time

Guidelines on POC coagulation testing (US)
Examples of manufacturers of POC tests

Abbott Laboratories
Axis-Shield
Siemens
Instrumentation Laboratory
Haemoscope
Helena Point of Care
Inverness Medical Innovations
International Technidyne
Roche Diagnostics
Akers Biosciences

Platelet function tests

POC testing

Examples of manufacturers of POC tests
Helena Point of Care
Siemens Healthcare Diagnostics
Accumetrics

Chapter 5 Cardiology tests

Summary
Overview of cardiovascular disease
Lipids associated with atherosclerosis

Lipid management guidelines (US)
Laboratory lipid profiling
Mail-in fingerstick tests

Point-of-care lipid tests

Routine assay methods
Examples of manufacturers of CLIA waived tests

AccuTech
Inverness Medical Innovations
Polymer Technology Systems
Abaxis

Cardiac protein biomarker diagnostics

Biomarkers of necrosis
Biomarkers of hemodynamic stress
Biomarker panels for risk stratification
The need for POC testing
Examples of manufacturers of POC tests

Siemens
Inverness Medical Innovations
ELITech Group
Roche Diagnostics
Response Biomedical
Abbott Point of Care

Chapter 6 Infectious disease tests

Summary
Introduction
POC testing

Rapid immunoassays
Nucleic acid testing

Sexually-transmitted diseases

HIV
Chlamydia
HPV
HSV-2
Trichomonas vaginalis
Gonorrhea

Respiratory infections

Influenza A and B
Influenza A swine flu
RSV
Strep A
Legionella
M. tuberculosis

Gastrointestinal infections

H. pylori
C. difficile
Parasites

Other infections/conditions

Enteroviral meningitis
Infectious mononucleosis
Hepatitis C
Strep B
MRSA
Sepsis
Malaria
Acute conjunctivitis
Platelet-associated bacteria
Periodontal disease
Urine infection

Chapter 7 Drugs of abuse testing

Summary
Introduction
Point-of-care urine-based testing
Commonly abused prescription drugs

Opioids
Central nervous system depressants
Stimulants
Psychoactive drugs
Methadone

Illicit drugs

Methamphetamine
Cocaine
Heroin
Phencyclidine
Cannabinoids

POC testing sites
CLIA waived DOA rapid tests
Examples of POC DOA test manufacturers

Inverness Medical Innovations
Nanogen
Bio-Rad Laboratories
Siemens Healthcare Diagnostics
Instant Technologies
NOVX Systems

Detection of DOA in oral fluids

Chapter 8 Clinical chemistry and other rapid tests

Summary
Introduction
Urinalysis reagent strips

Automated urinalysis

POC clinical chemistry analyzers

Examples of manufacturers

Abaxis
Abbott Laboratories
Arkray

Cancer POC testing

Colon cancer screening
Bladder cancer screening
Other products

Chapter 9 Company profiles

Summary
Abaxis Inc

Company description
POC technology/products

Abbott Laboratories

Company description
POC technology/products

Accumetrics

Company description
POC technology/products

AccuTech LLC

Company description
POC technology/products

Akers Biosciences Inc

Company description
POC technology/products

American Bio Medica Corporation

Company description
POC technology/products

AmniSure International LLC

Company description
POC technology/products

Arkray USA Inc

Company description
POC technology/products

Banyan Biomarkers Inc

Company description
POC technology/products

BioHelix Corporation

Company description
POC technology/products

Bio-Rad Laboratories Inc

Company description
POC technology/products

BiOracle Ltd

Company description
POC technology/products

Calypte Biomedical Corporation

Company description
POC technology/products

Cepheid

Company description
POC technology/products

Diazyme Laboratories

Company description
POC technology/products

ELITech Group

Company description
POC technology/products

Enigma Diagnostics Ltd

Company description
POC technology/products

GeneEx Inc

Company description
POC technology/products

Health-Chem Diagnostics LLC

Company description
POC technology/products

Helena Laboratories Corporation

Company description
POC technology/products

Home Diagnostics Inc.

Company description
POC technology/products

International Technidyne Corporation

Company description
POC technology/products

Inverness Medical Innovations Inc

Company description
POC technology/products

Meso Scale Diagnostics LLC

Company description
POC technology/products

Micronics

Company description
POC technology/products

Molecular Vision Ltd

Company description
POC technology/products

NOVX Systems Inc

Company description
POC technology/products

OraSure Technologies Inc

Company description
POC technology/products

Phadia AB

Company description
POC technology/products

PointCare Technologies Inc

Company description
POC technology/products

Polymer Technology Systems Inc

Company description
POC technology/products

Princeton BioMeditech Corporation

Company description
POC technology/products

Qualigen Inc

Company description
POC technology/products

Quidel Corporation

Company description
POC technology/products

Rapid Pathogen Screening Inc

Company description
POC technology/products

Response Biomedical Corporation

Company description
POC technology/products

Roche Diagnostics Corporation

Company description
POC technology/products

Siemens Healthcare Diagnostics Inc

Company description
POC technology/products

Trinity Biotech Plc

Company description
POC technology/products

Verax Biomedical Inc

Company description
POC technology/products

Chapter 10 Market analysis and forecasts

Summary
Outlook for the POCT market
Forecasts for individual POCT market sectors

Glucose monitoring
HbA1c testing
Pregnancy/fertility testing
Infectious disease testing
Lipid profiling
Cardiac marker testing
Coagulation testing
Drugs of abuse testing
Automated urine/blood analysis
Cancer screening

Penetrating the healthcare system

POCT in retail health clinics
POCT in physicians office labs

Future POCT technologies

Appendix

Research methodology
Glossary

List of Figures
Figure 1.1: Approaches to overcoming limitations of traditional PCR-based assays
Figure 1.2: A representative basic lateral flow immunoassay (LFI) device
Figure 1.3: Schematic of an electrochemical glucose biosensor with meter display
Figure 1.4: Schematic of a lab-on-a-chip device
Figure 1.5: Drivers & restraints for the POCT market
Figure 2.6: Patient potential for type 2 diabetes
Figure 2.7: Causes of inaccurate glucose test results
Figure 6.8: Infectious disease tests CLIA waived (%), Nov 2006 - Oct 2009
Figure 6.9: GeneXpert system for PCR-based DNA testing

List of Tables
Table 2.1: Glucose monitoring products 2006-09
Table 2.2: Glucose monitoring products 2006-09 (ctd 1)
Table 2.3: Glucose monitoring products 2006-09 (ctd 2)
Table 2.4: Glucose monitoring products 2006-09 (ctd 3)
Table 2.5: Glucose monitoring products 2006-09 (ctd 4)
Table 2.6: Glucose monitoring products 2006-09 (ctd 5)
Table 2.7: HbA1c testing products
Table 3.8: Pregnancy and ovulation tests
Table 3.9: Pregnancy and ovulation tests (ctd 1)
Table 3.10: Pregnancy and ovulation tests (ctd 2)
Table 3.11: Pregnancy and ovulation tests (ctd 3)
Table 5.12: Lipid profiling tests
Table 6.13: Infectious disease tests - Strep A infection
Table 6.14: Infectious disease tests - H. pylori infection
Table 6.15: Infectious disease tests - Infectious mononucleosis
Table 6.16: Infectious disease tests - HIV infection
Table 6.17: Infectious disease tests - influenza A/B infection
Table 6.18: Infectious disease tests - urinary infection
Table 7.19: Drugs of abuse (DOA) test systems and analytes
Table 7.20: Drugs of abuse (DOA) test systems and analytes (ctd 1)
Table 7.21: Drugs of abuse (DOA) test systems and analytes (ctd 1)
Table 8.22: Automated urine analyzers/reagents
Table 8.23: Automated urine analyzers/reagents (ctd 1)
Table 8.24: Automated urine analyzers/reagents (ctd 2)
Table 8.25: Blood chemistry analyzers/reagents
Table 8.26: Blood chemistry analyzers/reagents (ctd 1)
Table 8.27: Immunological Fecal Occult Blood (FOB) tests
Table 9.28: Abbott Laboratories sales to external customers ($m), 2006-08
Table 9.29: Cepheid product sales by market ($ thousands), 2007-08
Table 9.30: Inverness Medical Innovations sales ($ thousands), 2007-08
Table 9.31: Quidel POC diagnostic revenues ($ thousands), 2007-08
Table 10.32: POCT market forecast by application, 2008-13
Table 10.33: POCT market forecast by region, 2008-13