Contents:

EXECUTIVE SUMMARY INTRODUCTION Figure 1 - Examples Of Tests Performed In Various Point Of Care Settings Figure 2 - Logic Tree For Determining If A Diagnostic Is Appropriate For Use As A POCT Technologies Used in Point of Care Testing Introduction Figure 3 - A Variety Of Technologies Are Used In POC Testing. Immunoassays Figure 4 - Solid Phase Or Dipstick Immunoassay Figure 5 - Agglutination Test Figure 6 - Lateral Flow Test Enzymatic assays Figure 7 - Example Of An Enzymatic Reaction Used To Measure Glucose Chemical measurements Amperometric methods-electrodes Figure 8 - Clark-Type Oxygen Sensing Electrode INFORMATION TECHNOLOGY AND DATA INTEGERATION INFORMATION TECHNOLOGY AND DATA MANAGEMENT COMPANIES SERVING THE POINT OF CARE MARKET REGULATORY COMPLIANCE FOR POINT OF CARE TESTING POINT OF CARE TESTS ON MARKET BY APPLICATION Asthma Theophylline Testing Table 1 - POC Theophylline Test Blood Gas Measurements Blood Electrolyte Testing Hemoglobin Table 2 - POC Blood Gas, Electrolyte And Hemoglobin Tests Cardiovascular Disease BNP- B -Type Natriuretic Peptide, a Biochemical Marker for Heart Failure Table 3 - Point of Care Tests for BNP CK-MB Troponins Myoglobin Table 4 - POC Tests for Markers Associated with Acute Cardiac Syndrome Cholesterol and Triglycerides Table 5 - POC Tests to Measure Cholesterol and Lipids Kidney Disease Urinary albumin Table 6 - Point of Care Tests for Microalbuminuria Diabetes Glucose Monitoring Table 7 - Bedside Glucose Monitors Glycosylated Hemoglobin (glycohemoglobin, hemoglobin A1c) Table 8 - POC HbA1c Tests Urine and Blood Ketones Table 9 - POC Tests for Blood Ketones Hemostasis aPTT-Activated Partial Thromboplastin Time Test ACT-Activated Clotting Time Test PT-Prothrombin Time, International Normalized Ratio Table 10 - POC Blood Clotting Tests D-dimer Table 11 - POC D-Dimer Tests Platelet Function Tests Table 12 - POC Platelet Function Tests Infectious Disease Lyme Disease Table 13 - POC Test for Detection of Borrelia burgdorferi Chlamydia Table 14 - POC Tests for Detection of Chlamydial Infection Clostridium difficile Table 15 - POC Tests for Detection of Clostridium difficile H. pylori Table 16 - POC Tests for Detection of H. Pylori HIV Table 17 - POC Tests for HIV Infectious Mononucleosis Table 18 - POC Tests for Infectious Mononucleosis Infectious Vaginitis Table 19 - POC Tests for Infectious Vaginitis Influenza Table 20 - POC Tests for Influenza Legionella pneumophila Table 21 - POC Test for Legionella pneumophila RSV Table 22 - POC Tests for RSV Streptococcal Infections-StrepA Table 23 - POC Tests for Streptococcus pyogenes Trichomonas Vaginitis Table 24 - POC Test for Trichomonas vaginitis Inflammatory disease CRP-C-reactive Protein Table 25 - POC Tests for C-Reactive Protein Perinatal, Neonatal care Hyperbilirubinemia Table 26 - POC Bilirubin Tests ROM Table 27 - POC Test for Ruptured Fetal Membranes Oncology Alpha-fetoprotein (AFP) Blood Test Table 28 - POC Test for Alpha-fetoprotein PSA Table 29 - POC Tests for Prostate Specific Antigen NMP22 Table 30 - POC Tests for NMP22 Fecal Occult Blood Table 31 - POC Tests for Fecal Occult Blood TRENDS AND UNMET NEEDS MARKET DRIVERS MARKET MODELS Aggregate Market Figure 9 - Numbers of Companies with Offerings Figure 10 - Numbers of Point of Care Tests Offered by Indication Market Sizes and Trends Figure 11 - Market Sizes for POCT Addressing Cardiovascular Health, Inflammation, Asthma Figure 12 - Market Sizes for POCT Addressing Infectious Diseases Figure 13 - Market Sizes for POCT in Support Of Diabetes Treatment Figure 14 - Market Sizes for POCT Assisting in The Diagnosis Of Cancer Figure 15 - Market Sizes For Instrumentation Supporting POCT Test Costs Figure 16 - List Prices for POCTs Addressing Infectious Disease Figure 17 - List Prices for POCT Addressing Cardiovascular Disease, Hemostasis And Inflammatory Disease Figure 18 - List Prices for POCT Aiding In The Management Of Diabetes. Figure 19 - List prices of Instrumentation Supporting Cardiovascular Disease, Hemostasis And Inflammatory Disease POCT Figure 20 - List Prices for POC Instruments And Monitors Aiding In The Management Of Diabetes. Incidence and Prevalence of Indications Served by Point of Care Testing Figure 21 - US Incidence Of Acute Disease Indications Supported By POCT Figure 22 - US Prevalence Of Chronic Diseases Supported By POC Diagnostics APPENDIX METHODOLOGY Author Credentials Market Model Sources APPENDIX II LIST OF 2006 CLIA-WAIVED TESTS Hematology Urinalysis/Clinical Microscopy Chemistry Toxicology Bacteriology Virology Immunology Appendix III Company Profiles Abbott Diagnostics Abaxis Accumetrics AccuTech, LLC AGEN Biomedical Limited Avox Systems, Inc Axis-Shield PoC Bayer HealthCare Diagnostics Division Beckman Coulter BD (Becton, Dickinson and Company) Binax Bio-Rad Laboratories Biosite Cholestech Cortez Diagnostics, Inc. Dade Behring Diagnostic Chemicals Limited Dräger Medical AG & Co. KG Farallon Medical, Inc. Fujiribio Diagnostics Genzyme Diagnostics Germaine Laboratories, Inc. Helena Laboratories Corporation HemoCue Inc. HemoSense, Inc. Hypoguard USA, Inc. Immunostics, Inc. Instrumentation Laboratory Company International Technidyne (ITC) Inverness Medical Innovations Inc JANT PHARMACAL Corporation LifeScan, Inc Medtronic Diabetes N-Dia Inc. Nova Biomedical Corporation OraSure Technologies, Inc. Osmetech, Inc. Orion Diagnostica PerMaxim Polymedco Inc Polymer Technology Systems, Inc. (PTS) Princeton BioMeditech Provalis plc Quidel Corporation Radiometer America Inc. Reichert, Inc. Remel Respironics, Inc. Response Biomedical Corp Roche Diagnostics SA Scientific, Ltd. Serim Research Corporation Sienco, Inc. Stanbio Laboratory Teco Diagnostics Trinity Biotech Plc ZymeTx, Inc.

Companies Mentioned

Abbott Diagnostics Abaxis Accumetrics AccuTech, LLC AGEN Biomedical Limited Avox Systems, Inc Axis-Shield PoC Bayer HealthCare Diagnostics Division Beckman Coulter BD (Becton, Dickinson and Company) Binax Bio-Rad Laboratories Biosite Cholestech Cortez Diagnostics, Inc. Dade Behring Diagnostic Chemicals Limited Dräger Medical AG & Co. KG Farallon Medical, Inc. Fujirebio Diagnostics Genzyme Diagnostics Germaine Laboratories, Inc. Helena Laboratories Corporation HemoCue Inc. HemoSense, Inc. Hypoguard USA, Inc. Immunostics, Inc. Instrumentation Laboratory Company International Technidyne (ITC) Inverness Medical Innovations Inc JANT PHARMACAL Corporation LifeScan, Inc Medtronic Diabetes N-Dia Inc. Nova Biomedical Corporation OraSure Technologies, Inc. Osmetech, Inc. Orion Diagnostica PerMaxim Polymedco Inc Polymer Technology Systems, Inc. (PTS) Princeton BioMeditech Provalis plc Quidel Corporation Radiometer America Inc. Reichert, Inc. Remel Respironics, Inc. Response Biomedical Corp Roche Diagnostics SA Scientific, Ltd. Serim Research Corporation Sienco, Inc. Stanbio Laboratory Teco Diagnostics Trinity Biotech Plc ZymeTx, Inc.