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Point of Care Diagnostic Testing World Markets

  • August 2016
  • -
  • TriMark Publications
  • -
  • 449 pages

Point of care testing (POCT) enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or even days for outside lab results to arrive. Point of care testing covers: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening. This TriMark Publications report describes latest developments in the point of care testing market segment. It examines clinical instruments, devices and reagents and supplies as utilized in near-patient environments like hospital emergency rooms, critical care units, clinics and doctor's offices. The study defines the dollar volume of point of care sales and makes five year projections--both in the U.S. and worldwide--including Europe, Asia and Latin America. It also examines in detail the point of care sector for 25 individual country markets. A detailed summary of all important instruments in each clinical market is provided with emphasis on newly introduced products. Moreover, parallel areas where rapid detection is important using hand-held devices such as rapid detection of food pathogens and infectious diseases (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed. Growth moderators and developing trends in point of care applications, as well as technology platform innovations and connectivity questions are examined in detail. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product lines, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market data are also included.

Table Of Contents

Point of Care Diagnostic Testing World Markets










TABLE OF CONTENTS



1. Overview 19

1.1 About This Report 19

1.2 Scope of the Report 21

1.3 Objectives 21

1.4 Methodology 21

1.5 Executive Summary 23



2. Overview of Diagnostic Testing Point of Care Markets 27

2.1 Key Issues in the POC Diagnostic Testing Sector 30

2.1.1 Current Market Trends and Drivers 31

2.1.2 Effectiveness of POCT 32

2.1.3 New Growth Areas for POCT 32

2.1.4 Advantages of POCT in a Clinical Setting 33

2.1.5 Pricing and Reimbursement Issues 33

2.1.6 Key Customer Segments 34

2.2 Global Point of Care Marketplace 34

2.3 Shifts from Central Lab Testing to POCT 35

2.4 Geographical Distribution 35

2.5 Challenges of POCT 38

2.6 Key Issues for POCT 39

2.6.1 Locations of POCT 39

2.6.2 Milestones in Technology Development 41

2.6.3 Drive for Decentralization from Lab to Patient 41

2.6.4 Competitive Landscape for POCT 42

2.7 The Future of POCT 42



3. Summary Analysis of the Global POCT Market: Value, Growth Rates and Market
Share 45

3.1 Global POCT Market 45

3.2 Global Market Revenues Analysis by Market Segment 46

3.2.1 Global POC Blood Glucose Monitoring Systems Market 46

3.2.2 Global POC Blood Gas and Electrolyte Analyzers Market 47

3.2.3 Global POC Rapid Coagulation Analyzers Market 47

3.2.4 Global POC Cardiac Markers Devices Market 48

3.2.5 Global POC Substance Abuse Testing Device Market 49

3.2.6 Global POC Infectious Disease Testing Device Market 49

3.2.7 Global POC Urine Strip Testing Market 50

3.2.8 Global POC Pregnancy Testing Device Market 50

3.2.9 Global POC Fecal Occult Device Market 51

3.2.10 Global POC Cholesterol Testing Market 51

3.3 Global Market Share Analysis 52

3.4 Global Market Size by Geographic Location 52

3.5 Global Market Size by Analyte Market Segment 53

3.6 Global POCT Testing by Location 54



4. Analysis of the U.S. POCT Market: Value, Growth Rates and Market Share 55

4.1 U.S. Market Revenues Analysis by Market Segment 56

4.1.1 U.S. POC Blood Glucose Monitoring Systems Market 56

4.1.2 U.S. POC Blood Gas and Electrolyte Analyzers Market 56

4.1.3 U.S. POC Rapid Coagulation Analyzers Market 57

4.1.4 U.S. POC Cardiac Markers Devices Market 57

4.1.5 U.S. POC Substance Abuse Testing Device Market 59

4.1.6 U.S. POC Infectious Disease Testing Device Market 59

4.1.7 U.S. POC Urine Strip Testing Market 60

4.1.8 U.S. POC Pregnancy Testing Device Market 60

4.1.9 U.S. POC Fecal Occult Device Market 61

4.1.10 U.S. POC Cholesterol Testing Market 61

4.2 U.S. Market Share Analysis 62

4.3 U.S. Market Size by Analyte Market Segment 62



5. Analysis of the European POCT Market: Value, Growth Rates and Market Shares
64

5.1 European Market Revenues Analysis 70

5.2 European Market Revenues Analysis by Geographic Region 71

5.2.1 French Revenues for POCT Systems 71

5.2.2 German Revenues for POCT Systems 72

5.2.3 Italian Revenues for POCT Systems 72

5.2.4 Spanish Revenues for POCT Systems 73

5.2.5 U.K. Revenues for POCT Systems 73

5.2.6 Benelux Revenues for POCT Systems 74

5.2.7 Scandinavian Revenues for POCT Systems 74

5.2.8 Rest of Europe Revenues for POCT Systems 75

5.3 European Market Revenues Analysis by Market Segment 75

5.3.1 European POC Blood Glucose Monitoring Systems Market 75

5.3.2 European POC Blood Gas and Electrolyte Analyzers Market 76

5.3.3 European POC Rapid Coagulation Analyzers Market 77

5.3.4 European POC Cardiac Marker Market 77

5.3.5 European POC Substance Abuse Testing Device Market 79

5.3.6 European POC Infectious Disease Testing Market 80

5.3.7 European POC Urine Strip Testing Market 81

5.3.8 European POC Pregnancy Testing Device Market 81

5.3.9 European POC Fecal Occult Blood Testing Market 82

5.3.10 European POC Cholesterol Testing Market 83

5.4 European Market Share Analysis 84



6. Analysis of the POCT Markets for Japan, China and India: Value, Growth Rates
and Market

Share 85

6.1 Summary Analysis of Japanese, Chinese and Indian POCT Market Revenues 85

6.2 Summary of Asian (Japanese, Chinese and Indian) Market Revenues by Market
Segment 86

6.2.1 Asian (Japanese, Chinese and Indian) POC Blood Glucose Monitoring Systems
Market 86

6.2.2 Asian (Japanese, Chinese and Indian) POC Blood Gas and Electrolyte
Analyzers Market 86

6.2.3 Asian (Japanese, Chinese and Indian) POC Rapid Coagulation Analyzers
Market 87

6.2.4 Asian (Japanese, Chinese and Indian) POC Cardiac Markers Devices Market 87

6.2.5 Asian (Japanese, Chinese and Indian) POC Substance Abuse Testing Device
Market 88

6.2.6 Asian (Japanese, Chinese and Indian) POC Infectious Disease Testing Device
Market 88

6.2.7 Asian (Japanese, Chinese and Indian) POC Urine Strip Testing Market 89

6.2.8 Asian (Japanese, Chinese and Indian) POC Pregnancy Testing Device Market
89

6.2.9 Asian (Japanese, Chinese and Indian) POC Fecal Occult Device Market 90

6.2.10 Asian (Japanese, Chinese and Indian) POC Cholesterol Testing Market 90

6.3 Asian (Japanese, Chinese and Indian) Market Share Analysis 91

6.4 Summary Analysis of the Japanese POCT Market 91

6.5 Summary Analysis of the Indian POCT Market 94

6.6 Summary Analysis of the Chinese POCT Market 97



7. Analysis of the Rest of World (ROW) POCT Market: Value, Growth Rates and
Market Share 104

7.1 Summary Analysis of the ROW POCT Market Revenues 104

7.2 Summary of the ROW Market Revenues by Market Segment 105

7.2.1 ROW POC Blood Glucose Monitoring Systems Market 105

7.2.2 ROW POC Blood Gas and Electrolyte Analyzers Market 105

7.2.3 ROW POC Rapid Coagulation Analyzers Market 106

7.2.4 ROW POC Cardiac Markers Devices Market 106

7.2.5 ROW POC Substance Abuse Testing Device Market 107

7.2.6 ROW POC Infectious Disease Testing Device Market 107

7.2.7 ROW POC Urine Strip Testing Market 108

7.2.8 ROW POC Pregnancy Testing Device Market 108

7.2.9 ROW POC Fecal Occult Device Market 109

7.2.10 ROW POC Cholesterol Testing Market 109

7.3 ROW Market Share Analysis 110

7.4 Summary Analysis of the ROW POCT Market Revenues 110

7.4.1 Summary Analysis of the Argentinian POCT Market 110

7.4.2 Summary Analysis of the Australian POCT Market 111

7.4.3 Summary Analysis of the Brazilian POCT Market 111

7.4.4 Summary Analysis of the Canadian POCT Market 112

7.4.5 Summary Analysis of the Russian POCT Market 113

7.4.6 Summary Analysis of the Middle East POCT Market 113

7.4.7 Summary Analysis of the African POCT Market 114

7.4.8 Summary Analysis of the Asia-Pacific POCT Market 116



8. Review of the Market Segments, Reagents and Equipment 120

8.1 Blood Glucose Monitoring 120

8.1.1 Introduction to Blood Glucose Monitoring 120

8.1.2 Types of Blood Glucose Testing 121

8.1.2.1 Fasting Blood Sugar (FBS) or Fasting Plasma Glucose (FPG) 121

8.1.2.2 Two-Hour Postprandial Blood Sugar or Two-Hour PC 121

8.1.2.3 Random Blood Sugar (RBS) 121

8.1.2.4 Glucose Urine Test 121

8.1.2.5 Blood Glucose Test Strip 121

8.1.2.6 Glycosylated Hemoglobin (HbA1c) 122

8.1.2.7 Intravenous Glucose Tolerance Test (IVGTT) 122

8.1.2.8 Oral Glucose Tolerance Test (OGTT) 122

8.1.3 Segmentation of POC Blood Glucose Testing 122

8.1.3.1 Continuous Blood Glucose Monitoring (CBGM) 122

8.1.3.2 Self-Monitoring Blood Glucose (SMBG) Testing 124

8.1.3.3 Minimally-Invasive and Non-Invasive Blood Glucose Testing 124

8.1.3.4 Emerging Glucose Monitoring Technologies 124

8.1.3.5 Optical Transducer Technologies 125

8.1.3.6 Transdermal Sensor Technologies 126

8.1.3.7 Invasive Glucose Sensor Technologies 126

8.1.4 Review of Professional POC Blood Glucose Monitoring Systems 127

8.1.4.1 New Guidance: Use of Blood Glucose Monitoring Systems for Professional
and Home POC 127

8.1.5 Review of POC Blood Glucose Monitoring Products 128

8.1.5.1 Abaxis, Inc. 130

8.1.5.2 Abbott 130

8.1.5.3 Alere 132

8.1.5.4 Apex Biotechnology 132

8.1.5.5 ARKRAY, Inc. 132

8.1.5.6 DiaSys 133

8.1.5.7 EKF Diagnostics 133

8.1.5.8 Fora Care 134

8.1.5.9 HemoCue (part of Radiometer) 134

8.1.5.10 HMD BioMedical 134

8.1.5.11 Infopia 135

8.1.5.12 Instrumentation Laboratory 135

8.1.5.13 Jant Pharmacal 135

8.1.5.14 LifeHealth (formerly International Technidyne Corp.) 136

8.1.5.15 Medtronic 136

8.1.5.16 Nova Biomedical 137

8.1.5.17 Polymer Technology Systems 138

8.1.5.18 Radiometer 138

8.1.5.19 Randox Laboratories 139

8.1.5.20 Roche 140

8.1.5.21 Siemens 141

8.1.5.22 Stanbio Laboratory 142

8.1.5.23 Techno Medica Co., Ltd. 142

8.1.5.24 LifeScan 142

8.1.6 Professional POC Hemoglobin A1c (HbA1c) Testing 142

8.1.6.1 A. Menarini Diagnostics 143

8.1.6.2 Alere 143

8.1.6.3 Apex Biotechnology 144

8.1.6.4 Convergent Technologies GmbH andamp; Co. 144

8.1.6.5 DiaSys Diagnostic Systems 144

8.1.6.6 Diazyme Laboratories 144

8.1.6.7 EKF Diagnostics 145

8.1.6.8 Eurolyser 145

8.1.6.9 Green Cross Medis (formerly Ceragem Medisys) 145

8.1.6.10 HemoCue (a division of Radiometer) 146

8.1.6.11 Infopia 146

8.1.6.12 Roche 146

8.1.6.13 SD Biosensor 146

8.1.6.14 Siemens Healthcare Diagnostics 147

8.1.6.15 Erba Diagnostics 147

8.1.7 Market Analysis 147

8.1.7.1 Worldwide Professional Glucose Testing Market 149

8.1.7.2 U.S. Professional Glucose Testing Market 149

8.1.8 Competitive Analysis for the Glucose POCT Sector 150

8.1.9 Market Share for Glucose Testing 152

8.1.10 Competitive Analysis for the Glucose POCT Sector 152

8.1.11 Market Analysis 153

8.1.11.1 Market Drivers 153

8.1.11.2 Market Restraints 153

8.1.12 POC Glucose Testing Assay Market and Technology Trends 154

8.1.12.1 POC Glucose Testing Assay Market Trends 154

8.1.12.2 POC Glucose Testing Assay Technology Trends 154

8.1.12.3 POC Glucose Testing Assay Strategic Recommendations 154

8.2 Blood Gas and Electrolytes 155

8.2.1 Background to POC Blood Gas and Electrolyte Testing 155

8.2.1.1 Acid-Base Balance and the Lungs 156

8.2.1.2 Respiratory Acidosis 156

8.2.1.3 Respiratory Alkalosis 156

8.2.1.4 Metabolic (or Non-Respiratory) Acidosis 156

8.2.1.5 Metabolic (or Non-Respiratory) Alkalosis 156

8.2.1.6 Increasing Popularity of POC Blood Gas and Electrolyte Testing 157

8.2.2 Market Segmentation (Segmentation by Type of Blood Gas Monitoring
Equipment) 157

8.2.2.1 Intermittent Blood Gas Monitoring Equipment 157

8.2.2.2 Continuous Blood Gas Monitoring Equipment 157

8.2.2.3 EABG Monitors 158

8.2.2.4 IABG Monitors 158

8.2.2.5 Portable Blood Gas Analyzers 158

8.2.2.6 Patient-Attached On-Demand Blood Gas Analyzers 159

8.2.3 Applications for POCT Blood Gas and Electrolyte Analyzers 159

8.2.4 Emerging Technologies 159

8.2.5 Whole-Blood Lactate 159

8.2.6 Creatinine 159

8.2.7 Electrolytes Point of Care Analysis: Comparison of POCT and Central Lab
Results 160

8.2.8 Review of Selected Blood Gas and Electrolyte Analyzers 161

8.2.9 Review of Company Products 163

8.2.9.1 Roche Corporation 163

8.2.9.2 Siemens Healthcare Diagnostics 163

8.2.9.3 Instrumentation Laboratory 164

8.2.9.4 Nova Biomedical 165

8.2.9.5 Radiometer 165

8.2.9.6 Abbott Point of Care 165

8.2.9.7 Accriva Diagnostics 166

8.2.9.8 Alere 167

8.2.9.9 Opti Medical 167

8.2.10 Market Share for Blood Gas and Electrolyte Testing 167

8.2.11 Market Analysis 168

8.2.11.1 Market Drivers 168

8.2.11.2 Market Restraints 169

8.2.12 POC Blood Gas and Electrolyte Testing Assay Market and Technology Trends
169

8.2.12.1 POC Blood Gas and Electrolyte Testing Assay Market Trends 169

8.2.12.2 POC Blood Gas and Electrolyte Testing Assay Technology Trends 169

8.2.12.3 POC Blood Gas and Electrolyte Testing Assay Strategic Recommendations
170

8.3 Rapid Coagulation Tests 170

8.3.1 Background to Rapid Coagulation Tests 171

8.3.2 Review of Selected POC Rapid Coagulation Analyzers 177

8.3.3 Review of Company Products 179

8.3.3.1 Roche Diagnostics Corp. 179

8.3.3.2 Abbott Laboratories 181

8.3.3.3 Accriva 181

8.3.3.4 Medtronic 183

8.3.3.5 Alere 183

8.3.3.6 Helena Laboratories Point of Care 184

8.3.3.7 Sienco, Inc. 185

8.3.3.8 Instrumentation Laboratory's GEM PCL Plus 186

8.3.4 Connectivity Issues 187

8.3.5 Cost Benefits 187

8.3.6 Quality Control Issues 188

8.3.7 Certification for POC Coagulation Devices 189

8.3.8 D-Dimer Testing 189

8.3.9 Market Analysis 189

8.3.9.1 Market Share for POCT Coagulation Testing 189

8.3.9.2 Competitive Analysis of Sector Companies 190

8.3.9.3 Market Drivers 190

8.3.9.4 Market Restraints 191

8.3.9.5 POC Coagulation Testing Assay Market Trends 192

8.3.9.6 POC Coagulation Testing Assay Technology Trends 192

8.3.9.7 POC Coagulation Testing Assay Strategic Recommendations 193

8.3.9.8 SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and
Threats in the Coagulation POC Market 193

8.4 POC Rapid Cardiac Markers 194

8.4.1 Background to POC Rapid Cardiac Marker Testing 194

8.4.2 Cardiac Marker Tests 195

8.4.2.1 Creatine Kinase (CK) 195

8.4.2.2 Myoglobin 196

8.4.2.3 Cardiac Troponins T (TnT), I (TnI) and C (TnC) 197

8.4.2.4 C-Reactive Protein (CRP) 198

8.4.2.5 Homocysteine 199

8.4.3 Emerging Markers 200

8.4.3.1 B-Type Natriuretic Peptide (BNP) 200

8.4.3.2 Myeloperoxidase (MPO) 201

8.4.3.3 Ischemia-Modified Albumin (IMA) 201

8.4.3.4 Glycogen Phosphorylase Isoenzyme BB (GPBB) 202

8.4.3.5 Fatty Acid-Binding Proteins (FABPs) 202

8.4.4 Review of Selected POC Cardiac Biomarker Analyzers 202

8.4.5 Review of Company Products 204

8.4.5.1 Abbott's i-STAT System 204

8.4.5.2 Alere's Triage System 204

8.4.5.3 Alpha Scientific 205

8.4.5.4 Boditech Med's i-CHROMA System 206

8.4.5.5 BTNX 206

8.4.5.6 Homemed 206

8.4.5.7 LSI Medience (formerly Mitsubishi Chemical Medience Corp.) 207

8.4.5.8 Nano-Ditech 207

8.4.5.9 Princeton BioMeditech 207

8.4.5.10 Radiometer (part of Danaher) 207

8.4.5.11 Response Biomedical Corporation 208

8.4.5.12 Roche Diagnostics' cobas h 232 POC System 209

8.4.5.13 Roche's CARDIAC TROP T Sensitive Test (Visual) 210

8.4.5.14 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics,
Diagnostic Products Corporation and Dade Behring) 210

8.4.5.15 Trinity Biotech 211

8.4.5.16 Trivitron Healthcare (formerly Ani Biotech) 211

8.4.5.17 bioMerieux 211

8.4.6 Market Share and Sales for Cardiac Marker Testing 211

8.4.6.1 Market Drivers 213

8.4.6.2 Market Restraints 214

8.4.7 POC Cardiac Marker Testing Assay Market and Technology Trends 215

8.4.7.1 POC Cardiac Marker Testing Assay Market Trends 215

8.4.7.2 POC Cardiac Marker Testing Assay Technology Trends 216

8.4.7.3 POC Cardiac Marker Testing Assay Strategic Recommendations 216

8.5 POCT Substance Abuse Testing 217

8.5.1 Background to POC Substance Abuse Testing 217

8.5.2 Substance Abuse Test Types 224

8.5.2.1 Urine Substance/Drug Screening 224

8.5.2.2 Hair Tests for Substance Abuse and Screening 224

8.5.2.3 Blood Tests for Substance Abuse and Screening 225

8.5.2.4 Saliva Tests for Substance Abuse and Screening 225

8.5.2.5 Sweat Tests for Substance Abuse and Screening 225

8.5.3 Alcohol Abuse and Screening 225

8.5.4 Saliva Testing 226

8.5.5 Qualitative Analysis 226

8.5.5.1 Market Drivers 226

8.5.5.2 Market Restraints 227

8.5.6 Review of Selected POC Substance Abuse Analyzers 227

8.5.7 Review of Company Products 228

8.5.7.1 Alere 228

8.5.7.2 Abbott Diagnostics 229

8.5.7.3 BTNX, Inc. 229

8.5.7.4 BioScan Screening Systems, Inc. 230

8.5.7.5 American Bio Medica Corp. 231

8.5.7.6 Phamatech, Inc. 236

8.5.7.7 First Check Diagnostics Corp. (Alere, Inc.) 236

8.5.7.8 OraSure 237

8.5.7.9 Noble Medical, Inc. 237

8.5.7.10 Guangzhou Wondfo Biotech Co., Ltd. 237

8.5.7.11 Pathtech 237

8.5.7.12 Alfa Scientific Designs, Inc. 238

8.5.7.13 American Bio Medica 238

8.5.7.14 Biophor Diagnostics 238

8.5.7.15 Randox Laboratories 239

8.5.7.16 Branan Medical 239

8.5.7.17 Concateno 239

8.5.7.18 LifeSign 240

8.6 POC Pregnancy and Fertility Tests 240

8.6.1 Background to POC Pregnancy and Fertility Tests 240

8.6.2 Review of Selected POC Pregnancy Testing Devices 241

8.6.3 Review of Company Products 242

8.6.3.1 Quidel 242

8.6.3.2 Abbott Diagnostics 243

8.6.3.3 Alere 243

8.6.3.4 Sutherland Health Group Ltd. 243

8.6.3.5 Sekisui Diagnostics, LLC 243

8.6.3.6 Siemens Diagnostics 244

8.6.3.7 Orgenics (A subsidiary of Alere) 244

8.6.3.8 LifeSign 244

8.6.3.9 Other Companies in this Sector 244

8.6.3.10 Market Analysis 245

8.6.3.10.1 Competitive Sector Analysis 245

8.7 Fecal Occult Blood 245

8.7.1 Background to POC Fecal Occult Blood Testing 245

8.7.2 Review of Selected POC Fecal Occult Testing Devices 247

8.7.3 Review of Company Products 249

8.7.3.1 Helena Laboratories 249

8.7.3.2 Biomerica 249

8.7.3.3 Beckman Coulter 249

8.7.3.4 Worldwide Medical 250

8.7.3.5 Aerscher Diagnostics 250

8.7.3.6 Enterix 250

8.7.3.7 Medix Biochemica 250

8.7.3.8 Orion Diagnostica 251

8.7.3.9 ACON Laboratories' Mission FOB Reagent Strips 251

8.7.3.10 Alere's Products 251

8.7.3.11 Immunostics Hema-Screen 251

8.7.3.12 Princeton BioMeditech's BioSign iFOBTest 251

8.7.3.13 Quest Diagnostics' InSure FIT 251

8.7.3.14 Quidel's QuickVue iFOB 251

8.7.3.15 Exact Sciences' Cologuard 251

8.7.3.16 Epigenomics 252

8.7.3.17 CTK Biotech 252

8.7.4 Market Share for Fecal Occult Blood Testing 252

8.7.4.1 Company Analysis for the Fecal Occult Blood POCT Sector 252

8.7.5 Market Analysis 252

8.7.5.1 Market Drivers 252

8.7.5.2 Market Restraints 253

8.7.5.3 POC Fecal Occult Blood Testing Assay Market and Technology Trends 253

8.7.5.3.1 POC Fecal Occult Blood Testing Assay Market Trends 253

8.7.5.3.2 Fecal Occult Blood Testing Assay Technology Trends 254

8.7.5.3.3 POC Fecal Occult Blood Testing Assay Strategic Recommendations 254

8.8 POC Infectious Disease Testing 255

8.8.1 Background to POC Infectious Disease Testing 255

8.8.2 Types of Diagnosis for Infectious Diseases 256

8.8.2.1 Microbial Culture 256

8.8.2.2 Microscopy 256

8.8.2.3 Biochemical Tests 256

8.8.2.4 Immunologic Tests 256

8.8.2.5 Molecular Diagnostics Testing 257

8.8.3 Diagnostic Platforms for Infectious Diseases 257

8.8.3.1 Centralized Laboratory Testing for Infectious Diseases 257

8.8.3.2 POC Testing for Infectious Diseases 257

8.8.4 Emerging Technologies 258

8.8.5 Market Analysis 258

8.8.5.1 Market Drivers 259

8.8.5.2 Market Restraints 259

8.8.6 Review of Selected POC Infectious Disease Testing Devices 259

8.8.6.1 POC Infectious Disease Testing Devices and Assays in Development 262

8.8.6.1.1 Cepheid's GeneXpert Omni 262

8.8.6.1.2 Alere q 262

8.8.6.1.3 Quidel 262

8.8.6.1.4 Roche's cobas Liat System 263

8.8.6.1.5 QuantuMDx's Q-POC 263

8.8.6.1.6 SRI International 263

8.8.6.1.7 Atlas Genetics' io System 263

8.8.7 Overview of POC Assays for Detection of Infectious Disease 264

8.8.7.1 Anthrax and Other Bio-threats 264

8.8.7.2 Campylobacter 266

8.8.7.3 Clostridium difficile 266

8.8.7.4 E. coli 268

8.8.7.5 Gastrointestinal Infectious Agents 269

8.8.7.5.1 Giardia and Cryptosporidium 269

8.8.7.5.2 Entamoeba histolytica 270

8.8.7.5.3 Rotavirus andamp; Adenovirus 270

8.8.7.5.4 Norovirus 270

8.8.7.6 Hepatitis 271

8.8.7.7 Herpes Simplex Virus Type-2 273

8.8.7.8 Influenza 273

8.8.7.9 Legionella 278

8.8.7.10 Malaria Testing 279

8.8.7.11 Meningitis 281

8.8.7.12 Mononucleosis 281

8.8.7.13 Procalcitonin (Detects Sepsis) 282

8.8.7.14 Respiratory Tract Infections 283

8.8.7.14.1 C-Reactive Proteins 283

8.8.7.14.2 Pneumonia 284

8.8.7.14.3 Respiratory Tract Panels 284

8.8.7.15 RSV 284

8.8.7.16 Streptococcus 286

8.8.7.17 Rubella 286

8.8.7.18 Sexually-Transmitted Diseases 287

8.8.7.18.1 Chlamydia 287

8.8.7.18.2 Gonorrhea Testing 287

8.8.7.18.3 Syphilis 288

8.8.7.19 Staphylococcus aureus and MRSA 289

8.8.7.20 Streptococcus A Testing 290

8.8.7.21 Tropical Diseases 292

8.8.7.21.1 Chagas Disease 293

8.8.7.21.2 Dengue Fever 293

8.8.7.21.3 Ebola 294

8.8.7.21.4 Filariasis 294

8.8.7.21.5 Onchocerciasis 294

8.8.7.21.6 Zika Virus 294

8.8.7.22 Tuberculosis 294

8.8.7.23 Typhoid 296

8.9 POC Urine Strip Testing 296

8.9.1 Background to POC Urine Strip Testing 296

8.9.2 Emerging Technologies 298

8.9.3 Review of Selected POC Urine Strip Testing Devices 299

8.10 POC Cholesterol Testing 300

8.10.1 POC Cholesterol Testing Market Size and Development 300

8.10.2 Background to POC Cholesterol Testing 301

8.10.3 POC Cholesterol Testing Devices 303

8.10.3.1 Review of Selected POC Cholesterol Testing Devices 303

8.10.4 Review of Company Products 304

8.10.4.1 Cholestech (Now Alere) 304

8.10.4.2 Polymer Technology Systems 305

8.10.4.3 Miraculins 305

8.10.4.4 Abaxis, Inc. 305

8.10.5 Product Comparison of Leading Suppliers 306

8.10.6 Launch Dates of Leading Products Worldwide 308

8.11 Miscellaneous POC Tests 308

8.11.1 Estriol 308

8.11.2 POC H. pylori Testing 309

8.11.3 Bacterial Contamination of Platelet Units 311

8.11.4 POC Vaginal Fluid pH and Vaginitis Testing 312

8.11.5 POC Cancer Testing 312

8.11.5.1 Prostate-Specific Antigen (PSA) 312

8.11.5.2 Bladder Cancer 313

8.11.5.3 Other Rapid Cancer Tests 315

8.11.6 Fetal Status (PROM) 316

8.11.7 Hemodynamic Monitoring 316

8.11.8 Heparin-Induced Thrombocytopenia 317

8.11.9 Ruptured Fetal Membranes 317

8.11.10 Alcohol 318

8.11.12 Microalbumin Testing 318

8.11.13 Prenatal, Labor and Delivery Testing 318

8.11.13.1 Alere Triage PLGF 318

8.11.13.2 Medix Biochemica 319

8.11.14 Sperm Fertility 319

8.11.15 Surgical Coagulation and Hemostasis Management 319

8.11.16 Respiratory Tests 319

8.11.17 C-Reactive Protein 320

8.12 HIV 320

8.12.1 FDA-Approved Rapid HIV Assays 324

8.12.1.1 Alere 325

8.12.1.2 bioLytical Laboratories, Inc. 326

8.12.1.3 Bio-Rad Laboratories 327

8.12.1.4 Chembio Diagnostics 327

8.12.1.5 MedMira Laboratories, Inc. 327

8.12.1.6 OraSure Technologies 328

8.12.1.7 Trinity Biotech 329

8.12.2 Rapid HIV Assays Not Approved by the FDA (not commercially available in
the U.S.) 329

8.12.2.1 Alere 329

8.12.2.2 bioMerieux 330

8.12.2.3 Bio-Rad 330

8.12.2.4 Core Diagnostics 331

8.12.2.5 CTK Biotech 331

8.12.2.6 EY Laboratories 331

8.12.2.7 Hema Diagnostics Systems 332

8.12.2.8 ImmunoScience 332

8.12.2.9 InTec Products 332

8.12.2.10 JAL Innovation 332

8.12.2.11 J Mitra andamp; Co. 333

8.12.2.12 Premier Medical Corporation 333

8.12.2.13 Princeton BioMeditech 333

8.12.2.14 Savyon Diagnostics 334

8.12.2.15 Shanghai Kehua 334

8.12.2.16 Span Diagnostics 334

8.12.2.17 Tulip Group 334

8.12.2.18 YD Diagnostics' AIDScan 335

8.12.3 POC Viral Load Technologies of the Future 335

8.12.3.1 Cepheid 335

8.12.3.2 Roche 335

8.12.3.3 Wave 80 Biosciences 335



9. POCT: Growth Regulators 336

9.1 Moderators of Growth 336

9.2 Personnel Acceptance 336

9.3 Key People for POCT 337

9.4 Information Management Issues 337

9.4.1 Elements of Information Management for POCT: Information-Processing
Capabilities 337

9.4.2 Data Mining 338

9.4.3 Middleware 338

9.4.4 Web Portals 339

9.4.5 POCT-1A Standard 339

9.5 Key Elements for POCT 340

9.6 POCT and Reimbursement 340

9.7 Effectiveness of Clinical Outcomes 342

9.8 Rapid Near-Patient Testing in Hospitals 343

9.9 Satellite Facilities 343

9.10 Regionalization of Laboratory Care 344

9.11 Requirements for POCT 345

9.12 Locations of POC for Patient Care 346

9.13 Benefits of POCT 346

9.14 Cost Elements of POCT 346

9.15 Necessary Functions in POCT 347

9.16 Turnaround Time (TAT) for POCT 347

9.17 Clinical Laboratory Improvement Amendments (CLIA) 347

9.18 Sexually-Transmitted Diseases in Underdeveloped Countries 349

9.19 Sources of Error in POC Testing 349



10. Business Trends in the POC Sector 351

10.1 Sector Consolidation 351

10.2 Diagnostic Testing Growth Trends 352

10.2.1 Opportunities for Healthcare Stakeholders 353

10.3 Acquisition, License Agreements, Internal Development and Partnerships 353

10.4 Product Testing Depth in POCT 356

10.5 Government Regulation 356

10.5.1 U.S. Regulation 356

10.5.1.1 Importing Medical Devices into the U.S. 358

10.5.1.2 Exporting Medical Devices from the U.S. 359

10.5.2 E.U. Regulation 359

10.5.3 Japanese Regulation 362

10.6 Post-Filing Regulations for POC Devices 364

10.7 Exporting Unapproved POCTs 365

10.8 Analyte-Specific Reagents (“Home-Brew” Tests) 365

10.9 Medical Device Registration 365

10.10 Product Labeling 366

10.11 Punitive FDA Actions 366

10.12 CLIA ‘88 and State Laboratory Laws 366

10.13 Impact of Regulations on the Industry 367

10.14 Minimizing Regulatory Barriers 368

10.15 Waived Testing 370



11. Technology Platform Innovations in POCT 372

11.1 Latest POCT Technological Platforms 372

11.1.1 Device Miniaturization and Microfluidic Technologies 372

11.1.2 Minimally-Invasive and Non-Invasive POCT Technologies 373

11.1.2.1 Libre Flash Glucose Monitor and OneTouch Verio Sync Meter 373

11.1.2.2 Echo Therapeutics 373

11.1.3 Advances in Wireless Technologies 373

11.1.4 Automation of POCT 373

11.1.5 Developments in New Genomic Technologies (Genotyping, Haplotyping and
Sequencing

Technologies) 374

11.1.6 Advances in Informatics Technologies 376

11.1.7 Pharmacogenetic Testing 377

11.1.8 Multi-Assay Technologies in POCT 377

11.1.9 Molecular Diagnostic Technology in POCT for Infectious Disease 377

11.2 Smart Phone Technology 378

11.2.1 Aquila Diagnostic Systems, Inc. 378

11.2.2 AgaMatrix 379

11.2.3 Quick HIV and Syphilis Screening 379

11.2.4 Accu-Check Connect System 379

11.3 QuantuMDx Handheld, Portable Low Cost Rapid Devices 379



12. Data Management and Connectivity 381

12.1 Wireless LANs 381

12.2 Connectivity Platforms 383

12.2.1 Data Management Systems 384

12.2.1.1 Alere RALS System 385

12.2.1.2 International Technidyne Corporation HEMOCHRON Signature Elite 386

12.2.1.3 Siemens Diagnostics Rapidpoint 386

12.2.1.4 Radiometer 386

12.2.1.5 HemoCue's DM Hemoglobin 386

12.2.1.6 Roche Diagnostics Cobas IT 386

12.2.1.7 Accriva 387

12.2.3 BD.id 387

12.2.4 Medical Implant Communications Service (MICS) 387

12.2.5 Conworx Technology 387

12.2.6 Telcor QML 388

12.2.7 Medasys 388

12.2.8 NoemaLife 388

12.2.9 Telcare 388

12.3 Advantages of POCT Connectivity 388

12.3.1 Cost-Benefit Analysis of POCT and IT Connectivity 389

12.3.2 Hospital Network Issues 389



13. Corporate Profiles 391



14. POCT Sector Trends and Forecasts 431

14.1 Home Care Analysis as Part of Near-Patient Testing 431

14.2 Non-Traditional Collection for POCT 431

14.3 New Systems for Critical Care and Near-Patient Testing 432

14.4 Utility of Near-Patient Testing in Critical-Care Settings 432

14.5 Physician's Office Market 433

14.6 Information Management Advances 433

14.7 Test-Ordering Patterns and Demand for POCT 434

14.8 Demand for Emergency Department Services 434

14.9 Move Away from the Central Laboratory 435

14.10 Healthcare Cost Controls 436

14.11 Mergers andamp; Acquisitions 437

14.12 Competition for Services 437

14.13 Drivers of POCT 438

14.14 Confluence of New Technology 438

14.15 Difficulties of Design for POC Products 438

14.16 Point of Care Compliance 438

14.17 The Biggest New Opportunities in POCT 441



15. New Entrants to the Point of Care Market 442






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