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Molecular Diagnostics in Cancer Testing

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Publication Date:
May 2015; Pages: 242


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Molecular Diagnostics Cancer Sample

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

TABLE OF CONTENTS

1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 10
1.4 Objectives 10
1.5 Methodology 10
1.6 Executive Summary 12

2. Introduction to Molecular Diagnostics 19
2.1 Opening of Opportunities in Molecular Diagnostics 19
2.2 Impact of the Human Genome Project on Molecular Diagnostics 21
2.3 Considerations for Molecular and Clinical Diagnostics 21
2.4 Molecular Diagnostics in the Post-Genomic Era 24
2.5 Advances in Molecular Diagnostics Technologies 25
2.6 Oligonucleotide Array Platforms 27
2.7 Emerging Cancer Personalized Medicine Market 27
2.7.1 Predictive Cancer Molecular Diagnostics 29
2.8 Companion Tests for Drug Development 30
2.9 Opportunities for IVDMIA Companies 32

3. Cancer Diagnostics Molecular Testing Market 33
3.1 Market Description 37
3.1.1 Market Overview 37
3.1.2 Molecular Diagnostic Markers 38
3.1.3 Competitive Landscape 39
3.1.4 Sales and Marketing Strategies for Cancer Tests 41
3.1.4.1 North American Market 43
3.1.4.2 International Markets 43
3.1.4.3 Europe 44
3.1.4.4 Asia-Pacific 44

4. Molecular Diagnostic Tests for Cancer 45
4.1 Cancer Diagnostic Tests 45
4.1.1 Use of Genomics to Understand Cancer 47
4.1.2 Molecular Diagnostic Tools Solutions 48
4.1.3 Technology of Gene Expression Analysis 51
4.1.3.1 Amplify and Detect Diminished Amounts of RNA Consistently 51
4.1.3.2 Analyze Hundreds of Genes 52
4.1.3.3 Employ Advanced Information Technology 53
4.2 Breast Cancer 53
4.2.1 Cancer Prognostic Assays 55
4.2.1.1 Myriad Genetics (BRCA1 and BRCA2) 57
4.2.1.2 Genomic Health (Oncotype DX) 57
4.2.1.2.1 Single Gene Reporting (ER, PR, HER2) 60
4.2.1.2.2 Node Positive 60
4.2.1.2.3 Aromatase Inhibitors 60
4.2.1.2.4 Product Development 60
4.2.1.2.5 Product Development Opportunities in Breast Cancer 61
4.2.1.3 InterGenetics, Inc. 61
4.2.1.4 LabCorp (HER-2) 63
4.2.1.5 Clarient Diagnostic Services (GE Healthcare) 65
4.2.1.6 BioTheronostics (AviaraDx) 66
4.2.1.7 Agendia B.V. (MammaPrint) 66
4.2.1.8 Oncogene Science (Wilex) 68
4.2.1.9 Ventana Medical Systems 70
4.2.2 Competition and Comparison of Methods 70
4.2.3 Competitive Structure and Market Share Analysis 71
4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 73
4.2.3.1.1 Global Market 73
4.2.3.1.2 U.S. Market 73
4.2.3.1.3 European Market 74
4.2.3.2 Market Forecasts 75
4.2.3.2.1 Revenue Forecasts 75
4.2.3.3 Market Drivers and Restraints 75
4.2.3.3.1 Market Drivers 75
4.2.3.3.2 Market Restraints 76
4.2.3.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 76
4.2.3.4.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 76
4.2.3.4.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 76
4.2.3.4.3 Breast Cancer Testing Assay Strategic Recommendations 76
4.3 Colorectal Cancer Molecular Diagnostics Market 77
4.3.1 Colon Cancer Testing Platforms 79
4.3.1.1 Genomic Testing 79
4.3.1.1.1 IVD Multiplex Index Analysis 79
4.3.1.1.2 The BRAF Test 79
4.3.1.1.3 KRAS 80
4.3.1.1.3.1 Background on KRAS Mutation 80
4.3.1.1.4 mSEPT9 84
4.3.1.2 Screening Test 84
4.3.2 Players in the Colorectal Cancer Space 85
4.3.3 Competitive Structure and Market Share Analysis 91
4.3.3.1 Colon Cancer Molecular Diagnostic Testing Market Size 91
4.3.3.1.1 Global Colon Cancer Testing Market 91
4.3.3.1.2 U.S. Colon Cancer Testing Market 91
4.3.3.1.3 European Colon Cancer Testing Market 92
4.3.3.2 Market Forecasts 92
4.3.3.2.1 Revenue Forecasts 93
4.3.3.3 Market Drivers and Restraints 93
4.3.3.3.1 Market Drivers 93
4.3.3.3.2 Market Restraints 94
4.3.3.4 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 94
4.3.3.4.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 94
4.3.3.4.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 94
4.3.3.4.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 95
4.4 Prostate Cancer Molecular Diagnostics Market 97
4.4.1 Screening for Prostate Cancer 97
4.4.1.1 PSA Screening Test for Prostate Cancer 97
4.4.1.2 PCA3 Screening Test for Prostate Cancer 98
4.4.1.3 Gen-Probe (Hologic, Inc.) 101
4.4.1.4 Beckman Coulter (Danaher) Prostate Health Index 102
4.4.1.5 Opko Health 4KScore 103
4.4.1.6 Metabolon Prostarix DRE Urine Test 103
4.4.2 Tests After Positive Biopsy 104
4.4.2.1 Myriad Genetics (Prolaris) 104
4.4.2.2 Genomic Health (Genomic Prostate Score) 104
4.2.2.3 Bostwick Laboratories (ProstaVysion) 104
4.2.2.4 Metamark Genetics (Biopsy Test) 105
4.4.3 Tests After Negative Biopsy 105
4.4.3.1 Mitomics (Prostate Core Test) 105
4.4.3.2 MDxHealth (ConfirmMDx) 106
4.4.4 Tests After Surgery 106
4.4.4.1 GenomeDx Sciences (Decipher) 106
4.4.4.2 Iris International (Nadia ProsVue) 106
4.4.5 Competition and Comparison of Methods 107
4.4.6 Competitive Structure and Market Share Analysis 108
4.4.7 Market Drivers and Restraints 108
4.4.7.1 Market Drivers 108
4.4.7.2 Market Restraints 109
4.4.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 109
4.4.8.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends 109
4.4.8.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends 110
4.5 Other Cancer Molecular Diagnostic Markets 112
4.5.1 Bladder Cancer 112
4.5.2 Ovarian Cancer 113
4.5.2.1 Incidence of Ovarian Cancer 113
4.5.2.2 Key Players in Ovarian Testing Market 117
4.5.2.3 Ovarian Cancer Market Size 120
4.5.2.4 Ovarian Cancer Molecular Diagnostic Testing Market Size 121
4.5.2.4.1 Global Ovarian Cancer Testing Market 121
4.5.2.4.2 U.S. Ovarian Cancer Testing Market 121
4.5.2.4.3 European Ovarian Cancer testing Market 122
4.5.2.5 Market Forecasts 122
4.5.2.5.1 Revenue Forecasts 123
4.5.2.6 Market Drivers and Restraints 123
4.5.2.6.1 Market Drivers 123
4.5.2.6.2 Market Restraints 124
4.5.2.7 Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 124
4.5.2.7.1 Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends 124
4.5.2.7.2 Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends 124
4.5.2.7.3 Ovarian Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 124
4.5.3 Lung Cancer 125
4.5.4 Melanoma 131
4.6 Molecular Diagnostic Screening Test for Cancer 132
4.6.1 Extreme Drug Resistance Assay (Oncotech EDR Assay) 133
4.6.2 Multidrug Resistance Protein 134
4.7 Companion Diagnostic Tests for Cancer Therapeutics 134

5. Business 138
5.1 Technology and Market Trends 138
5.1.1 Technology Trends 139
5.1.2 Market Trends 140
5.2 M&A Activity 142
5.3 Partnerships 145
5.4 Competitive Analysis 148
5.4.1 Primary Competitors 154
5.4.1.1 Summary of Market Strengths, Weaknesses, Opportunities and Threats 155
5.4.2 Industry Challenges and Strategic Recommendations 156
5.4.3 Commercialization of Molecular Diagnostic Products 157
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 159
5.6 Intellectual Property Rights 174
5.6.1 BRCA1 and BRCA2 Gene Patents 175
5.6.2 Current Patent Disputes 176

6. Reimbursement and Billing 177
6.1 Overview 177
6.2 Trends in Reimbursement Practice 177
6.2.1 Medicare Reimbursement 178
6.2.2 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules 181
6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 182
6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms 182
6.3 Breast Cancer Tests 182
6.4 Colon Cancer Tests 184
6.5 Trends in Patient Care and Reimbursement 186
6.6 Revenue Threats 188
6.6.1 Medicare Exceptions 189
6.6.2 Three Areas for Denial of Claims by Biomarkers 189
6.7 Billing 190
6.7.1 Medicare Billing Procedures 190
6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers 191

7. Government Regulation 192
7.1 U.S. Food and Drug Administration 192
7.2 CLIA Regulations 193
7.3 Clinical Laboratory Improvement Act 194
7.4 State Licensing for Service Laboratories 195
7.5 FDA Treatment of Multivariate Index Assays 196
7.6 510(k) Clearance 197
7.7 Pre-Market Approval 197
7.8 ASRs 197
7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 198
7.10 U.S. Patent and Trademark Office 199
7.11 IRB Approval in Clinical Trials 199
7.12 Oncology Biomarkers Qualification Initiative Project 199
7.13 FDA Clearance Picture for Insight Dx, MammaPrint and Oncotype DX 200
7.14 FDA Packaging Requirements for Erbitux 200
7.15 Microarray Quality Control 200
7.16 CAP Evidence-Based Recommendations to Improve the Accuracy of ER and PR Testing 201
7.17 ER and PR Proficiency Testing 201

8. Business Decisions Using Molecular Diagnostic Tests in Cancer Test Development 202
8.1 What are the Key Opportunities for Development of Cancer Tests Based Upon Molecular Diagnostics Technologies? 202
8.2 What are the Current Obstacles for Implementation of Molecular Diagnostics for Cancer? 202
8.3 How do Business Strategies, Such as those Relating to Acquisition, Drive Biomarker Strategies? 203
8.4 Which Types of Cancer Testing Should be Developed by Molecular Diagnostic Companies at Various Stages in the Development Pipeline? 203
8.5 How Can Regulatory Oversight Drive Approval and Adoption of New Technologies? 203
8.6 What are the Noteworthy Deals? 204
8.7 Who are the Acquirers? 205
8.8 Who are the Target Companies? 205
8.9 In What Class of Drugs is the Value of Using Genetic Biomarkers in Decision-Making the
Highest? 205
8.10 How Can Regulatory Oversight Drive Approval and Adoption of New Technologies? 205
8.11 How can Big Pharma Co-Develop Genetic Biomarkers for Regulatory Acceptance? 206
8.12 How are Genetic Biomarkers Being Used to Reduce the Attrition Rate in Drug Development? 206
8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development? 206
8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and how Should R&D Organizations Address this Problem? 206
8.15 How to Maximize Business Development through Biomarker Strategies? 207
8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers? 207
8.17 What are Organizational Impediments in Genetic Biomarkers in Drug Development? 207
8.18 What are Internal Capabilities for Novel Biomarker Development and Application? 207
8.19 How can Key Biomarker Technical Expertise be Applied Across a Complex and Highly-Stratified R&D Value Chain? 208
8.20 At what Stage of Drug Development has Genetic Biomarkers Provided the most Benefit? 208
8.21 What Companies are the most Innovative in Development of Genetic Biomarkers? 208
8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics 211
8.23 Molecular Diagnostic Tests Can Increase Value in an Associated Drug 211
8.24 Business Developments in Next Generation Sequencing 212

9. Company Profiles 213
9.1 Agendia 213
9.2 ArcticDx, Inc. 213
9.3 Biodesix 214
9.4 bioTheranostics (AviaraDx) 214
9.5 Cancer Genetics, Inc. 215
9.6 Clarient, Inc. (GE Healthcare) 216
9.7 CombiMatrix Corporation 216
9.8 Epigenomics 217
9.9 Exact Sciences Corporation 218
9.10 Exagen Diagnostics, Inc. 218
9.11 Exiqon 219
9.12 Ferrer inCode 219
9.13 Genomic Health, Inc. 219
9.14 Genoptix, Inc. 220
9.15 InterGenetics, Inc. 221
9.16 LabCorp 221
9.17 Myriad Genetics, Inc. 221
9.18 Nanostring 225
9.19 Neogenomics 225
9.20 Nuvera Biosciences 225
9.21 Orion Genomics 225
9.22 Qiagen NV 225
9.23 Rosetta Genomics Ltd. 227
9.24 Seegene 227
9.25 Sequenom, Inc. 228
9.26 SABiosciences Corporation (Qiagen) 228
9.27 Source MDx 228
9.28 Targeted Molecular Diagnostics 228
9.29 Wilex, Inc. 229

Appendix 1: Definition of Terms for Molecular Diagnostics 230
Appendix 2: Standard Cancer Therapeutic Panels 232
Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize Cancer 235
Appendix 4: Technical Assessment of the Kirsten RNA Associated Rat Sarcoma 2 Virus Gene (KRAS) Mutation Test by Several Methodologies and Specialty Oncology Laboratories 237
Appendix 5: Overview of Microarrays 239


INDEX OF FIGURES

Figure 2.1: Finding Genes with Microassays 20
Figure 2.2: Use of Microassays for Studying Gene Expression 20
Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 21
Figure 2.4: Microarrays for Prediction of Survival in Cancer 23
Figure 2.5: Finding New Drugs with Microarrays 28
Figure 2.6: Using Gene Expression Patterns to Chose Treatment 29
Figure 2.7: Segmentation of the Biomarker Development Market 30
Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2014 34
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing in the U.S., 2014 34
Figure 3.3: Market Share for Key Companies in Global Molecular Diagnostics Cancer Testing Market 35
Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers 42
Figure 4.1: Using DNA Microassays to Measure Gene Expression 47
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 48
Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy 62
Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 64
Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 64
Figure 4.6: Action of Herceptin in Breast Cancer Patients 65
Figure 4.7: Analysis of Cancer Tissue by Microarray 67
Figure 4.8: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2014 73
Figure 4.9: Incidence of CRC by Age Group 78
Figure 4.10: HNPCC Mutation Increases Risk of Cancer 89
Figure 4.11: APC Mutation Increases Risk of Cancer 89
Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2014 92
Figure 4.13: Prostate-Specific Membrane Antigen 98
Figure 4.14: PCA3 Score Nomogram 100
Figure 4.15: Estimates for PCA3 Test Volume in the U.S., 2005-2012 101
Figure 4.16: Ovarian Cancer Types 114
Figure 4.17: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2014 122
Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 146
Figure 5.2: Segmentation of the Biomarker Development Market 172
Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2011 183
Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 200


INDEX OF TABLES

Table 2.1: Genes and Cancer Risk 23
Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 28
Table 2.3: Targeted Drug Therapies for Cancers 28
Table 2.4: Use of Cancer Biomarkers in Drug Development 31
Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development 31
Table 2.6: Time Line for Development of Companion Diagnostics 32
Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2011-2021 33
Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2011-2021 33
Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2014 34
Table 3.4: Key Diagnostic Companies in the Global Molecular Diagnostics Cancer Testing Market 35
Table 3.5: Key Laboratory Testing Companies in the Global Molecular Diagnostics Cancer Testing
Market 35
Table 3.6: Business Factors Influencing Advanced Oncology Testing Services 36
Table 3.7: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 37
Table 3.8: Highlights of the Cancer Diagnostic Testing Segment 38
Table 3.9: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic
Services 38
Table 3.10: Strategies for Marketing Cancer Diagnostic Products 42
Table 3.11: Key Elements of MDx Diagnostic Companies Marketing Plan 43
Table 4.1: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2014 45
Table 4.2: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2014 46
Table 4.3: Emerging Molecular Diagnostic Technologies 49
Table 4.4: Key Elements for Business Competition in Gene Expression Profiling for Cancer 51
Table 4.5: Key Elements for Future Success in the Gene Profiling for Cancer Segment 52
Table 4.6: Companies Marketing Products in the Cancer Molecular Diagnostics Sector 52
Table 4.7: Breast Cancer Overview 54
Table 4.8: Overview of ER/PR Testing and Response to Therapy 55
Table 4.9: Key Players in the Breast Cancer Molecular Diagnostic Space 56
Table 4.10: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay 56
Table 4.11: Clinical Utility and Health Economic Benefits of Oncotype DX 58
Table 4.12: Oncotype DX Overview 58
Table 4.13: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 59
Table 4.14: Overview of HER2/neu and Herceptin 63
Table 4.15: MammaPrint: Key Features 68
Table 4.16: Oncogene Science Biomarker Group Reagents 69
Table 4.17: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic
Tests, 2014 72
Table 4.18: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2014 73
Table 4.19: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2014 74
Table 4.20: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2015-2021 75
Table 4.21: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2015-2021 75
Table 4.22: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of
Impact 75
Table 4.23: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of
Impact 76
Table 4.24: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market 77
Table 4.25: Colorectal Cancer Overview 79
Table 4.26: KRAS Mutation Assay 80
Table 4.27: KRAS Assays by Analytical Type 81
Table 4.28: KRAS Mutation Analysis Summary 81
Table 4.29: DxS KRAS Mutation Test Summary 82
Table 4.30: KRAS and BRAF in Clinical Use 83
Table 4.31: Product Development Opportunities in Cancer Tumor Types, 2008 84
Table 4.32: Key Players in the Colorectal Cancer Molecular Diagnostic Space 85
Table 4.33: ArcticDx Genetic Test, Colo Risk 88
Table 4.34: NexCourse CRC Test Offering and Treatment Direction 90
Table 4.35: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2014 91
Table 4.36: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2014 92
Table 4.37: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2015-2021 93
Table 4.38: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2015-2021 93
Table 4.39: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of
Impact 93
Table 4.40: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of
Impact 94
Table 4.41: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 96
Table 4.42: Stages in Prostate Cancer Discovery and Diagnosis 97
Table 4.43: Corporate Players Entering the Prostate Cancer Molecular Diagnostic Space 98
Table 4.44: Gen-Probe Genetic Testing Product Line 102
Table 4.45: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of
Impact 108
Table 4.46: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of
Impact 109
Table 4.47: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market 109
Table 4.48: Players in the Bladder Cancer Molecular Diagnostic Space 112
Table 4.49: Clinical Applications of Serum Biomarkers for Ovarian Cancer 114
Table 4.50: Commercially Available Molecular Diagnostic Products for Ovarian Cancer Assay 120
Table 4.51: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2014 121
Table 4.52: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2014 121
Table 4.53: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2015-2021 123
Table 4.54: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2015-2021 123
Table 4.55: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 123
Table 4.56: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 124
Table 4.57: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market 125
Table 4.58: Lung Cancer Survival Rates 125
Table 4.59: Lung Cancer Facts 126
Table 4.60: Pharmacogenetic Markers for Select Cancer Drugs 130
Table 4.61: Potential of Cancer Biomarkers in Drug Delivery and Development 135
Table 4.62: Barriers to Adoption of Biomarkers in Clinical Use 135
Table 5.1: Technology Trends in Cancer Testing 139
Table 5.2: Trends in Theranostics 140
Table 5.3: Market Trends in Cancer Testing 141
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 141
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 142
Table 5.6: Companies that Offer Products to Profile Gene Expression in Breast Cancer 154
Table 5.7: Principal Competitive Factors in the Cancer Screening Market 155
Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care
Market 156
Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 156
Table 5.10: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges 157
Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development 174
Table 6.1: CPT Codes for Tumor Markers 180
Table 6.2: Genomic Health Oncotype DX Sales, 2006-2014 183
Table 6.3: Drivers in KRAS Testing 185
Table 6.4: Factors Determining Third-Party Payment for Advanced Cancer Tests 188
Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business 192
Table 7.2: Focus Areas for the FDA Critical Path Initiative 199
Table 8.1: Effect of Regulation on MDx Cancer Market Technology Platforms, 2007 and 2015 203
Table 8.2: Partnerships Between Pharmaceutical and Diagnostic Companies, 2009-Present 209
Table A2.1: Serum Tumor Markers Currently in Common Use 234

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