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World Glucose Self-Testing Markets Published on January 2012

Report Summary The worldwide incidence of diabetes is dramatically increasing, and it is estimated that 439 million people will have developed the disease by 2030. As such, the global market for blood glucose self-testing products is undergoing a significant transition driven by the advent of new analytical technologies and new recommendations for tight glucose control for monitoring diabetes. In addition, the proliferation of the middle class within developing nations, particularly China and India, has resulted in both a substantial rise in Type 2 diabetes and the financial means to manage the disease. The purpose of this TriMark Publications report is to provide a comprehensive analysis of the specific segment of the over-the-counter diagnostics sector known as the glucose self-testing market. The term "self-testing" is used to distinguish it from in vitro diagnostics testing for blood glucose in hospitals, commercial labs and doctor's offices, the so-called "professional" component of the glucose testing market. This study reviews the viable technology drivers and assesses the market dynamics of the glucose self-testing market worldwide. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. Detailed tables and charts with sales forecasts and market share data are also included.

Table of Content

TABLE OF CONTENTS

1. Overview 10 1.1 Statement of Report 10 1.2 About This Report 11 1.3 Scope of the Report 12

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2. Diabetes 16 2.1 Demographics of Diabetes 18 2.1.1 Worldwide Diabetes Incidence 18 2.1.2 Diabetes in the U.S. 19 2.2 Economics of Diabetes 24 2.3 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 29 2.3.1 Pre-Diabetes Syndrome 31 2.3.2 Metabolic Syndrome 31 2.3.3 Progression of Diabetes 31 2.3.4 Diabetes and Inflammation 31 2.3.5 Risk Factors and Diabetes 32 2.3.5.1 Obesity 33 2.3.6 Complications and Co-morbidities in Type 2 Diabetes 35 2.3.7 Hypoglycemia and Treatment 37 2.3.8 Cardiovascular Disease Facts 37

3. Market Analysis: Size, Growth, Share and Competitors 44 3.1 Worldwide Glucose Testing Market 44 3.1.1 Global Glucose Self-testing Market Share 47 3.1.2 Continuous Glucose Monitoring Markets 49

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>> Get this Report Now by email! 3.2 U.S. Market 50 3.2.1 Over-the-Counter (OTC) Self-testing Glucose Market 54 3.3 European Market 56 3.4 Asian Market 57 3.4.1 Japanese Market 59 3.4.2 Chinese Market 60 3.4.3 Indian Market 62 3.4.4 Korean Market 63 3.4.5 Southeast Asian Market 63 3.4.6 ROW Markets 64 3.5 Competitive Situation 64 3.5.1 Key Players 64 3.5.2 Analyses of the Current Market Conditions, Competition and Product Mix 65 3.6 Market Drivers and Restraints 68 3.6.1 Market Drivers 68 3.6.2 Market Restraints 69 3.7 Market and Product Trends 70 3.7.1 Market Trends 71 3.7.2 Technology Trends 72 3.8 Strategic Recommendations 73 3.9 Competitive Strategies 74 3.10 Adjacent Markets 75

4. Glucose Monitoring Recommendations 76

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>> Get this Report Now by email! 4.1 Tight Glucose Control in Treating Diabetes 76 4.2 Recommendations for Glucose Control in Diabetic Patients 76 4.2.1 Recommended Frequency of Blood Glucose Testing 77 4.2.2 Using Blood Glucose Data to Monitor and Modify Patient Therapy 78 4.2.3 Testing in Individuals with Type 2 diabetes 78 4.2.4 Continuous Glucose Monitoring (CGM) 79 4.2.5 A1c Testing Recommendations 80

5. Glucose Self-testing Technology Platforms and Consumable Products 82 5.1 Types of Glucose Self-testing Devices 82 5.2 Enzymatic Reactions Used in Glucose Self-testing Devices 83 5.2.1 Glucose Oxidase (GOX) 83 5.2.2 Glucose Dehydrogenase (GDH) 84 5.2.2.1 GDH-NAD (Glucose Dehydrogenase-Nicotinamide Adenine Dinucleotide) 84 5.2.2.2 GDH-FAD (Glucose Dehydrogenase-Flavin Adenine Dinucleotide) 84 5.2.2.3 GDH-PQQ (Glucose Dehydrogenase-Pyrroloquinoline Quinone) 84 5.3 Development of Blood Glucose Monitors: A Historical Evaluation 85 5.3.1 First Generation Blood Glucose Biosensors 85 5.3.2 Second Generation Blood Glucose Biosensors 85 5.3.3 Third Generation Blood Glucose Biosensor 85 5.4 Accuracy and Precision in Glucose Meters 86 5.4.1 FDA Recommendations 87 5.4.2 Determining Clinical Accuracy Using the Error Grid Analysis (EGA) 88 5.4.3 Calibration Methods 89

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>> Get this Report Now by email! 5.4.4 Common User Errors 89 5.5 Key Issues for Glucose Self-testing Devices 90 5.5.1 Important Elements for Glucose Self-testing 91 5.5.2 Key Features to Aid Specific Patient Populations 93 5.6 Limitations of Existing Glucose Self-testing Products 93 5.7 Interfering Substances and Conditions 94 5.7.1 Environmental 94 5.7.2 Physiologic 94 5.7.3 Operational 95 5.7.4 Manufacturing Variations 95 5.7.5 Drugs 95 5.7.5.1 Errors Associated with GDH-PQQ Technology 95 5.8 Potential Areas of Improvement in Blood Glucose Monitor Performance 98 5.9 Continuous Glucose Monitoring Technology 99 5.9.1 Advantages of Continuous Readings 99 5.9.2 FDA Approval of CGM 100 5.9.3 CGM Functions to Consider 101 5.9.4 New Technologies for CGM 101 5.10 Summary of Technologies being Explored for Non-invasive Glucose Monitoring 102 5.10.1 Goals of Non-invasive Testing 103 5.11 A1c Monitoring Technology 104 5.12 Related Reagents and Equipment 105 5.12.1 Lancets 105 5.12.2 Control Solutions and Calibrators 113

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>> Get this Report Now by email! 5.12.3 Sharps Devices 113 5.12.4 Needle Destruction Devices 114 5.13 New Developments in Glucose Self-testing Systems 114 5.13.1 Voice Operated Glucose Self-testing Meters 114 5.13.2 Bluetooth-enabled Glucose Self-testing Meters 117 5.13.2.1 MyGlucoHealth Wireless Meter 117 5.13.2.2 Fora D15b, Fora G31 and Fora D30 Meters 117 5.13.2.3 Meters with Wireless Connectivity in Development 117 5.13.3 Glucose Self-testing Meters with Computer Connectivity 117 5.13.4 Data Management 118 5.13.4.1 Log Sheets/Spreadsheets 118 5.13.4.2 Glucose Self-testing Software 118 5.13.4.3 Smart Phone and iPad/iPod Touch Applications 119 5.13.4.4 Separate Devices 120 5.13.5 Telemedicine 120 5.13.6 Integrated Testing: Glucose Meter, Test Strips, and Lancet 121 5.13.7 Long-term Glucose Sensing Bio-implants 121 5.13.8 Glucose Self-testing Meters that Wirelessly Communicate with Insulin Pumps 122 5.13.8.1 Medtronic's MiniMed Paradigm Revel 122 5.13.8.2 Nova Max Link 122 5.13.8.3 One Touch Ultra Link 122 5.13.8.4 One Touch Ping 122 5.13.9 Ford's Onboard Sync System to Display Glucose Levels Measured by Patient's CGM 122

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>> Get this Report Now by email! 6. Glucose Self-testing Meters on the Market: Description of Test Meters 124 6.1 Blood Glucose Self-testing Meters and Strips 124 6.1.1 LifeScan 127 6.1.2 Roche Diagnostics Corporation 129 6.1.3 Bayer 130 6.1.4 Abbott (MediSense) 131 6.1.5 Agamatrix, Inc. 133 6.1.6 Arkray, Inc. 135 6.1.7 Bionime Corporation 136 6.1.8 BioSense Medical Devices 138 6.1.9 Diabetic Supply of Suncoast 138 6.1.10 Prodigy Diabetes Care, LLC (an Affiliate of Diagnostic Devices, Inc.) 139 6.1.11 Entra Health Systems 140 6.1.12 Fifty50 Pharmacy 141 6.1.13 Fora Care 141 6.1.14 Nipro Diagnostics, Inc. 141 6.1.15 Nova Biomedical 143 6.1.16 Oak Tree International Holdings, Inc. 143 6.1.17 U.S. Diagnostics 143 6.1.18 77 Elektronika Kft. 144 6.1.19 A. Menarini Diagnostics 145 6.1.20 Allmedicus 145 6.1.21 i-SENS 145 6.1.22 Apex Biotechnology Corp. 146

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>> Get this Report Now by email! 6.1.23 GenExel-Sein, Inc. 146 6.1.24 Glucoplus, Inc. 146 6.1.25 Polymer Technology Systems 146 6.1.26 Smiths Medical MD, Inc. 147 6.1.27 TaiDoc Technology Corp. 147 6.1.28 IN4 Technology Corporation 147 6.1.29 ACON Laboratories 147 6.1.30 HemoCue 148 6.1.31 Pepex Biomedical 148 6.1.32 Comparisons of Popular Blood Glucose Self-monitoring Meters 148 6.2 Continuous and Non-invasive Glucose Patient Monitoring Systems 149 6.2.1 Medtronic's Continuous Glucose Monitoring Systems (CGMS) 152 6.2.2 FreeStyle Navigator'Abbott's Continuous Glucose Monitor System 153 6.2.3 DexCom, Inc. STS Continuous Glucose Monitoring System 154 6.2.4 GlucoDay S Continuous Glucose Monitor 155 6.2.5 Minimally-invasive Continuous Glucose Monitors in Development 155 6.2.5.1 GlySens, Inc. 155 6.2.5.2 Sensors for Medicine and Science 156 6.2.5.3 Ultradion 156 6.3 Non-invasive Glucose Patient Monitoring Systems in Development 156 6.3.1 Cygnus GlucoWatch Biographer 157 6.3.2 AiMedics 157 6.3.3 BioTex 157 6.3.4 Calisto Medical 158

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>> Get this Report Now by email! 6.5.10 Medtronic Announces Mac Compatibility for CareLink Personal Therapy Management Software for Diabetes 165 6.6 New Blood Glucose Meters and Data Management Software in Development 165 6.6.1 LifeScan's iPhone App 165 6.6.2 Sanofi-Aventis's iBGStar 165 6.6.3 Jazz Wireless 166 6.6.4 Fora Care G31 and D30 166 6.7 Recent Industry Activity 166 6.7.1 Roche Diagnostics Corp Expanding Indianapolis Manufacturing Plant 166 6.7.2 AgaMatrix and Sanofi-Aventis Enter Global Diabetes Partnership 166 6.7.3 LifeScan, Inc. Terminates Exclusive Supply Agreement with Medtronic MiniMed 167 6.7.4 Kroger Selects WaveSense Diabetes Testing Products 167 6.7.5 Medtronic and Bayer Healthcare Expand International Alliance 167 6.7.6 Medtronic Opens New Diabetes Center in San Antonio 167 6.7.7 Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips in the U.S. and Puerto Rico 167 6.7.8 Abbott Receives FDA Clearance for New, Easier-to-Use FreeStyle Lite Test Strips 168 6.7.9 DexCom Receives CE Mark Approval for the SEVEN Continuous Glucose Monitoring System 168 6.8 M&A Activity 168 6.8.1 Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. Merge to become

Nipro Diagnostics, Inc. 168

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7. Business Trends in the Industry 174 7.1 Wholesale Distribution Overview 174 7.2 Factors Affecting OTC Medical Product Distribution 175 7.3 Drugstores Critical to the Diabetic Care Category 177 7.4 Drivers of OTC and Self-testing Markets 178 7.4.1 Brand Loyalty 178 7.5 Cost Elements of Glucose Self-testing 178 7.6 Important Elements of OTC Testing 179 7.7 Growth of Home Care and Self-testing 179 7.8 Blood Glucose Self-testing Insurance Coverage and Reimbursement 179 7.8.1 American OTC Testing and Self-testing Reimbursement 179 7.8.2 European Reimbursement 180 7.9 Government Regulation of Medical Devices 181 7.9.1 U.S. Regulations 181 7.9.2 U.K. Regulations 183 7.10 Clinical Laboratory Improvement Act (CLIA) 185 7.11 M&A Activity 187 7.12 Important Deals in BGM Market 188

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>> Get this Report Now by email! 8. Technology Trends 189 8.1 Improving Today's OTC Blood Glucose Meters 189 8.2 Biosensor Technology 190 8.3 Fructosamine Test 192 8.4 World Telemedicine Devices 192 8.4.1 Remote Patient Monitoring 194 8.4.1.1 Infopia Eocene System 197 8.4.2 Health Buddy Systems Monitoring Technologies 197 8.5 Non-Traditional Methods for Sample Collection 197 8.6 Data Management 198 8.6.1 Receiver Technology 198 8.6.2 Connectivity 198 8.6.3 DataLink Data Management System 201 8.6.4 RALS-Plus 202 8.6.5 LifeScan Electronic Data Interfaces 204 8.6.6 FDA Required Software Verification 205

9. OTC Testing: Critical Issues 206 9.1 Moderators of Growth for OTC Testing 206 9.2 Attitudes of Critical Care Nurses and Physicians 206 9.3 Personnel Impact for OTC Testing 207 9.4 Data Management Issues 207 9.5 POC Decentralization Issues 207 9.6 POC Testing and Clinical Outcomes 207

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10. Current Issues for OTC and Diagnostic Self-testing 211 10.1 New Markets for OTC and Diagnostic Self-testing 211 10.2 Utility of OTC and Self-testing 214 10.3 Corporate Screening 214 10.4 Generational Drivers of Home Testing 216 10.5 Move Away from Central Laboratories 218 10.6 Healthcare Cost Controls 218 10.7 Mergers of Diagnostic Companies 218 10.8 Home Healthcare Trends 218 10.9 Home Healthcare Providers versus Mass Market Retailers 218 10.10 Demographic Merchandising 219 10.11 Marketing Strategies 219 10.12 Third-party Pharmacy Networks 220 10.13 Which Customer Segments Purchase Home Healthcare' Which Products Fit Their Needs' 220 10.14 Future of Patient Self-testing 222

11. SWOT Analysis 223 11.1 Roche 223 11.2 LifeScan 224

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>> Get this Report Now by email! 12. Company Profiles 226 12.1 Abbott Laboratories 226 12.2 ACON Laboratories 226 12.3 AgaMatrix 226 12.4 Allmedicus 226 12.5 Amedica Biotech 226 12.6 Apex Biotechnology Corporation 227 12.7 Arkray 227 12.8 Bayer 227 12.9 B. Braun Melsungen 228 12.10 Bionime 228 12.11 Cambridge Sensors 228 12.12 DexCom 228 12.13 Diagnostic Devices/Prodigy Diabetes Care 229 12.14 Echo Therapeutics 229 12.15 Entra Health Systems 229 12.16 Fora Care 229 12.17 Genesis Health Technologies 229 12.18 GlucoPlus 229 12.19 Hainice Medical 229 12.20 Home Diagnostics 229 12.21 Infopia 230 12.22 IN4 Technology 230 12.23 i-Sens 230

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INDEX OF FIGURES

Figure 2.1: Worldwide Rates of Diabetes Cases, 2000-2030 20 Figure 2.2: Prevalence of Diabetes by Age in the U.S., 2010 21 Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010 22 Figure 2.4: County-specific Diabetes Prevalence in the U.S., 2007 22 Figure 2.5: Rate of New Diabetes Cases among Children in the U.S., 2007 23 Figure 2.6: Diabetes Death Rate by Race and Sex in the U.S., 1979-2006 24 Figure 2.7: How Diabetes Dollars are Spent in the U.S., 2007 28 Figure 2.8: Maintenance of Normal Blood Sugar Levels 31 Figure 2.9: Prevalence of Obesity Among Men Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 34

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>> Get this Report Now by email! Figure 2.10: Prevalence of Obesity Among Women Aged 20 Years and Older by Race/Ethnicity in the U.S., 1988-1994 and 2007-2008 35 Figure 2.11: Trends in Obesity Among Children and Adolescents in the U.S., 1963-2008 35 Figure 2.12: Hypertension Drugs Newly Prescribed or Continued in the U.S., 1994-2007 41 Figure 3.1: Worldwide Diabetes Monitoring Market Segments, 2011 46 Figure 3.2: Global Unit Sales of Glucose Testing Reagent Strips, 2011 47 Figure 3.3: Geographic Segments of the Worldwide Glucose Self-testing Market, 2010 and 2015 49 Figure 3.4: Worldwide Glucose Self-testing Market by Region, 2015 49 Figure 3.5: Continuous Glucose Market Growth Rates by Region, 2009-2018 50 Figure 3.6: U.S. Blood Glucose Reagent Strip Market, 2005-2015 53 Figure 5.1: EGA Zones of Clinical Accuracy 89 Figure 5.2: Single-day Continuous Blood Glucose Data 95 Figure 5.3: Personal Lancet Unit Sales Market Share by Geographic Region, 2011 112 Figure 6.1: Roche Diagnostics' Global Sales of Blood Glucose Monitors, 2003-2010 167

INDEX OF TABLES

Table 2.1: Criteria for the Diagnosis of Diabetes 18 Table 2.2: Categories of Increased Risk for Diabetes 19 Table 2.3: Countries with the Largest Numbers of Diabetics, 2010 and 2030 20 Table 2.4: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010 21

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>> Get this Report Now by email! Table 2.5: U.S. Incidence of Diagnosed Diabetes by Age, 2009 23 Table 2.6: Cost of Diagnosed Diabetes in the U.S., 2007 25 Table 2.7: Cost of Type 1 and Type 2 Diabetes in the U.S., 2007 25 Table 2.8 Total Cost of Diabetes in the U.S., 2007 25 Table 2.9: Per-event Costs of Diabetes Complications 27 Table 2.10: Healthcare Utilization by Diabetic Patients, 2008 27 Table 2.11: Clinical Recommendations for Adults with Diabetes 28 Table 2.12: Ten Leading Diagnoses for Co-morbid Chronic Diseases in the U.S., by Percentage of Patient Visits, 2006 29 Table 2.13: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 36 Table 2.14: Prevalence of Complications Among Patients with Diabetes 36 Table 2.15: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 37 Table 2.16: Major Causes of End-stage Renal Disease 37 Table 2.17: Average Years Gained Free of Diabetes-related Disease with Intensive Management 38 Table 2.18: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008 40 Table 2.19: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 40 Table 2.20: Top 20 Drugs for 2010 by U.S. Sales 42 Table 3.1: Total Global Unit Demand for Glucose Testing Reagent Strips, 2010-2016 47 Table 3.2: Global Dollar Sales of Glucose Testing Reagent Strips, 2010-2016 47 Table 3.3: Worldwide Glucose Self-testing Market Sales (Meters and Strips), 2005-2015 48 Table 3.4: World Market Share of Glucose Self-testing Marketers, 2011 50

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>> Get this Report Now by email! Table 3.5: Market for Glucose Self-testing in the U.S., 2005-2015 51 Table 3.6: U.S. Blood Glucose Reagent Strip Market, 2005-2015 52 Table 3.7: Market Share of U.S. Blood Glucose Self-testing, 2011 52 Table 3.8: U.S. OTC Glucose Self-testing Market Repeat Retail Replacement Sales Percentages 53 Table 3.9: OTC Blood Glucose Instrument Reagents by Manufacturer Retail 55 Table 3.10: Demographic Characteristics Glucose Self-testing Kit Buyers 56 Table 3.11: Top Brand Preferences for Glucose Self-testing Kits 56 Table 3.12: Instances when Patients Prefer Professional's Glucose Testing 56 Table 3.13: Advantages of a Glucose Self-testing Kit 56 Table 3.14: Disadvantages of Using a Glucose Self-testing Kit 57 Table 3.15: Popular Shopping Destinations for Buying or Seeking Information on Glucose Self-testing Kits 57 Table 3.16: Customer Priorities'Glucose Meter Self-testing Market, 2001-2012 57 Table 3.17: European Glucose Self-testing Market (Meters and Strips), 2005-2015 58 Table 3.18: European Glucose Self-testing Market by Country, 2010 58 Table 3.19: Asian Glucose Self-testing Market (Meter and Strips), 2005-2015 60 Table 3.20: Japanese Glucose Self-testing Market (Meters and Strips), 2005-2015 61 Table 3.21: Chinese Glucose Self-testing Market (Meters and Strips), 2005-2015 62 Table 3.22: Indian Glucose Self-testing Market (Meters, Strips, Lancets), 2005-2015 63 Table 3.23: Southeast Asian Glucose Self-testing Market by Country (Meters and Strips), 2010 64 Table 3.24: Southeast Asian Glucose Self-testing Market (Meters and Strips),

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>> Get this Report Now by email! Table 5.8: Unit Sales of Homecare Lancets in the U.S., 2003-2015 109 Table 5.9: Unit Sales of Homecare Lancets in the E.U., 2003-2015 109 Table 5.10: Dollar Sales of Homecare Lancets in the U.S., 2003-2015 110 Table 5.11: Dollar Sales of Homecare Lancets in the E.U., 2003-2015 110 Table 5.12: Unit Sales of Homecare Glucose Self-testing Lancets in the U.S., 2003-2015 111 Table 5.13: Unit Sales of Homecare Glucose Self-testing Lancets in the E.U., 2003-2015 111 Table 5.14: Competition in the Lancet Market Segment 112 Table 6.1: Current Blood Glucose Self-testing Meters: Sample Size, Test Time, and Other Features 125 Table 6.2: Performance Comparison of Popular Self-testing Glucose Meters 128 Table 6.3: Detailed Features of Selected CGM Systems Currently Available 150 Table 6.4: Non-invasive Glucose Monitoring Systems in Development 158 Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs 187 Table 8.1: Features for Future Meters 191 Table 8.2: Leading World Patient Monitoring Products in the U.S. Market 194 Table 8.4: Customized Reports Must Support CAP and JCAHO Requirements 203 Table 8.5: Applications of RALS Connectivity with POCT Devices 204 Table 9.1: POC Testing: Cost Analysis 210 Table 9.2: POC Testing: Cost Analysis with Labor Included 210

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