Molecular Diagnostics in Cancer Testing

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Date: 01-Jun-2016
No. of pages: 201
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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.

Molecular Diagnostics in Cancer Testing

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 17
2.1 Opening of Opportunities in Molecular Diagnostics 17
2.2 Impact of the Human Genome Project on Molecular Diagnostics 19
2.3 Considerations for Molecular and Clinical Diagnostics 19
2.4 Molecular Diagnostics in the Post-Genomic Era 22
2.5 Advances in Molecular Diagnostics Technologies 23
2.6 Oligonucleotide Array Platforms 24
2.7 Emerging Cancer Personalized Medicine Market 25
2.7.1 Predictive Cancer Molecular Diagnostics 27
2.8 Companion Tests for Drug Development 27
2.9 Opportunities for IVDMIA Companies 32
2.10 Next Generation Sequencing (NGS) 33
2.11 Multi-Gene Cancer Panels 33
2.12 Liquid Biopsy 34

3. Cancer Diagnostics Molecular Testing Market 35
3.1 Market Description 40
3.1.1 Market Overview 40
3.1.2 Molecular Diagnostic Markers 40
3.1.3 Competitive Landscape 41
3.1.4 Sales and Marketing Strategies for Cancer Tests 43
3.1.4.1 North American Market 45
3.1.4.2 International Markets 45
3.1.4.3 Europe 46
3.1.4.4 Asia-Pacific 46

4. Molecular Diagnostic Tests for Cancer 47
4.1 Cancer Diagnostic Tests 47
4.1.1 Use of Genomics to Understand Cancer 49
4.1.2 Molecular Diagnostic Tools Solutions 50
4.1.3 Technology of Gene Expression Analysis 53
4.1.3.1 Amplify and Detect Diminished Amounts of RNA Consistently 53
4.1.3.2 Analyze Hundreds of Genes 54
4.1.3.3 Employ Advanced Information Technology 55
4.2 Breast Cancer 55
4.2.1 Cancer Prognostic Assays 57
4.2.1.1 Myriad Genetics (BRCA1 and BRCA2) 59
4.2.1.2 Genomic Health (Oncotype DX) 59
4.2.1.2.1 Single Gene Reporting (ER, PR, HER2) 61
4.2.1.2.2 Node Positive 62
4.2.1.2.3 Aromatase Inhibitors 62
4.2.1.2.4 Product Development 62
4.2.1.2.5 Product Development Opportunities in Breast Cancer 63
4.2.1.3 LabCorp (HER-2) 64
4.2.1.4 Clarient Diagnostic Services (GE Healthcare) 66
4.2.1.5 BioTheronostics (AviaraDx) 67
4.2.1.6 Agendia B.V. (MammaPrint) 67
4.2.1.7 Genetic Technologies Ltd. 69
4.2.1.8 Ventana Medical Systems (Roche) 70
4.2.1.9 Ambry Genetics 71
4.2.1.10 Counsyl 71
4.2.1.11 Quest Diagnostics 71
4.2.1.12 Invitae 71
4.2.1.13 Gene By Gene 71
4.2.1.14 Bioreference Laboratories 72
4.2.1.15 Sophia Genetics 72
4.2.2 Competition and Comparison of Methods 72
4.2.3 Competitive Structure and Market Share Analysis 73
4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 74
4.2.3.1.1 Global Market 74
4.2.3.1.2 U.S. Market 75
4.2.3.1.3 European Market 76
4.2.3.2 Market Forecasts 77
4.2.3.2.1 Revenue Forecasts 77
4.2.3.3 Market Drivers and Restraints 77
4.2.3.3.1 Market Drivers 77
4.2.3.3.2 Market Restraints 78
4.2.3.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 78
4.2.3.4.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 78
4.2.3.4.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 78
4.2.3.4.3 Breast Cancer Testing Assay Strategic Recommendations 78
4.3 Colorectal Cancer Molecular Diagnostics Market 79
4.3.1 Colon Cancer Testing Platforms 81
4.3.1.1 Genomic Testing 81
4.3.1.1.1 IVD Multiplex Index Analysis 81
4.3.1.1.2 The BRAF Test 81
4.3.1.1.3 KRAS 82
4.3.1.1.3.1 Background on KRAS Mutation 82
4.3.1.1.4 mSEPT9 84
4.3.1.2 Screening Test 85
4.3.2 Players in the Colorectal Cancer Space 85
4.3.2.1 Agendia 85
4.3.2.2 BioTheranostics 86
4.3.2.3 Clarient 86
4.3.2.4 Genomic Health 86
4.3.2.5 Epigenomics 86
4.3.2.6 Exact Sciences 87
4.3.2.7 Qiagen 89
4.3.2.8 Arctic Dx 89
4.3.2.9 Myriad Genetics 89
4.3.2.10 Exiqon Diagnostics 91
4.3.2.11 Genoptix Medical 91
4.3.2.12 Genomictree 91
4.3.3 Competitive Structure and Market Share Analysis 91
4.3.3.1 Colon Cancer Molecular Diagnostic Testing Market Size 92
4.3.3.1.1 Global Colon Cancer Testing Market 92
4.3.3.1.2 U.S. Colon Cancer Testing Market 92
4.3.3.1.3 European Colon Cancer Testing Market 93
4.3.3.2 Market Forecasts 93
4.3.3.2.1 Revenue Forecasts 94
4.3.3.3 Market Drivers and Restraints 94
4.3.3.3.1 Market Drivers 94
4.3.3.3.2 Market Restraints 95
4.3.3.4 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 95
4.3.3.4.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 95
4.3.3.4.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 95
4.3.3.4.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 96
4.4 Prostate Cancer Molecular Diagnostics Market 97
4.4.1 Screening for Prostate Cancer 98
4.4.1.1 PSA Screening Test for Prostate Cancer 98
4.4.1.2 PCA3 Screening Test for Prostate Cancer 99
4.4.1.3 Hologic, Inc. 102
4.4.1.4 Beckman Coulter (Danaher) Prostate Health Index 103
4.4.1.5 Opko Health 4KScore 104
4.4.1.6 Metabolon Prostarix DRE Urine Test 104
4.4.1.7 Exome Diagnostics 105
4.4.2 Tests After Positive Biopsy 105
4.4.2.1 Myriad Genetics (Prolaris) 105
4.4.2.2 Genomic Health (Oncotype Dx) 105
4.4.2.3 Bostwick Laboratories (ProstaVysion) 105
4.4.2.4 Metamark Genetics (ProMark) 106
4.4.3 Tests After Negative Biopsy 106
4.4.3.1 Mitomics (Prostate Core Test) 106
4.4.3.2 MDxHealth (ConfirmMDx) 107
4.4.4 Tests After Surgery 107
4.4.4.1 GenomeDx (Decipher) 107
4.4.4.2 Iris International (Nadia ProsVue) 108
4.4.5 Competition and Comparison of Methods 108
4.4.6 Competitive Structure and Market Share Analysis 109
4.4.7 Market Drivers and Restraints 109
4.4.7.1 Market Drivers 109
4.4.7.2 Market Restraints 110
4.4.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 110
4.4.8.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends 110
4.4.8.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends 111
4.5 Other Cancer Molecular Diagnostic Markets 113
4.5.1 Bladder Cancer 113
4.5.2 Ovarian Cancer 114
4.5.2.1 Incidence of Ovarian Cancer 114
4.5.2.2 Key Players in Ovarian Testing Market 116
4.5.2.3 Ovarian Cancer Market Size 118
4.5.2.4 Ovarian Cancer Molecular Diagnostic Testing Market Size 119
4.5.2.4.1 Global Ovarian Cancer Testing Market 119
4.5.2.4.2 U.S. Ovarian Cancer Testing Market 119
4.5.2.4.3 European Ovarian Cancer testing Market 120
4.5.2.5 Market Forecasts 120
4.5.2.5.1 Revenue Forecasts 121
4.5.2.6 Market Drivers and Restraints 121
4.5.2.6.1 Market Drivers 121
4.5.2.6.2 Market Restraints 122
4.5.2.7 Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 122
4.5.2.7.1 Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends 122
4.5.2.7.2 Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends 122
4.5.2.7.3 Ovarian Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 122
4.5.3 Lung Cancer 123
4.5.4 Melanoma 129
4.6 Molecular Diagnostic Screening Test for Cancer 130
4.6.1 Extreme Drug Resistance Assay (Oncotech EDR Assay) 130
4.6.2 Multidrug Resistance Protein 130
4.7 Companion Diagnostic Tests for Cancer Therapeutics 131

5. Business 135
5.1 Technology and Market Trends 135
5.1.1 Technology Trends 136
5.1.2 Market Trends 137
5.2 M&A Activity 139
5.3 Partnerships 143
5.4 Competitive Analysis 144
5.4.1 Primary Competitors 149
5.4.1.1 Summary of Market Strengths, Weaknesses, Opportunities and Threats 150
5.4.2 Industry Challenges and Strategic Recommendations 152
5.4.3 Commercialization of Molecular Diagnostic Products 152
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 154
5.6 Intellectual Property Rights 169
5.6.1 BRCA1 and BRCA2 Gene Patents 169
5.6.2 Current Patent Disputes 170

6. Reimbursement and Billing 171
6.1 Overview 171
6.2 Trends in Reimbursement Practice 171
6.2.1 Medicare Reimbursement 171
6.2.2 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules 175
6.2.3 Reimbursement for Oncotype Dx, MammaPrint 175
6.3 Breast Cancer Tests 176
6.4 Colon Cancer Tests 178
6.5 Trends in Patient Care and Reimbursement 178
6.6 Revenue Threats 180
6.6.1 Medicare Exceptions 181
6.6.2 Three Areas for Denial of Claims by Biomarkers 181
6.7 Billing 182
6.7.1 Medicare Billing Procedures 182
6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers 183

7. Government Regulation 184
7.1 U.S. Food and Drug Administration 184
7.2 CLIA Regulations 185
7.3 Clinical Laboratory Improvement Act 185
7.4 State Licensing for Service Laboratories 187
7.5 FDA Treatment of Multivariate Index Assays 187
7.6 510(k) Clearance 188
7.7 Pre-Market Approval 189
7.8 ASRs 189
7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 189
7.10 U.S. Patent and Trademark Office 190
7.11 IRB Approval in Clinical Trials 190
7.12 Oncology Biomarkers Qualification Initiative Project 191
7.13 FDA Clearance Picture for Insight Dx, MammaPrint and Oncotype DX 191
7.14 Microarray Quality Control 191
7.15 ER and PR Proficiency Testing 192

8. Business Decisions Using Molecular Diagnostic Tests in Cancer Test Development 193
8.1 What are the Key Opportunities for Development of Cancer Tests Based Upon Molecular Diagnostics Technologies? 193
8.2 What are the Current Obstacles for Implementation of Molecular Diagnostics for Cancer? 193
8.3 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies? 194
8.4 Which Types of Cancer Testing should be Developed by Molecular Diagnostic Companies at Various Stages in the Development Pipeline? 194
8.5 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 194
8.6 What are the Noteworthy Deals? 195
8.7 Who are the Acquirers? 196
8.8 Who are the Target Companies? 197
8.9 In what Class of Drugs is the Value of Using Genetic Biomarkers in Decision-Making the Highest? 197
8.10 How Can Regulatory Oversight Drive Approval and Adoption of New Technologies? 198
8.11 How can Big Pharma Co-Develop Genetic Biomarkers for Regulatory Acceptance? 198
8.12 How are Genetic Biomarkers Being Used to Reduce the Attrition Rate in Drug Development? 198
8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development? 198
8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and how should R&D Organizations Address this Problem? 198
8.15 How to Maximize Business Development through Biomarker Strategies? 199
8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers? 199
8.17 What are Organizational Impediments in Genetic Biomarkers in Drug Development? 199
8.18 What are Internal Capabilities for Novel Biomarker Development and Application? 199
8.19 How can Key Biomarker Technical Expertise be Applied Across a Complex and Highly-Stratified R&D Value Chain? 200
8.20 At what Stage of Drug Development has Genetic Biomarkers Provided the most Benefit? 200
8.21 What Companies are the most Innovative in Development of Genetic Cancer Biomarkers? 200
8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics 203
8.23 Molecular Diagnostic Tests can Increase Value in an Associated Drug 203
8.24 Business Developments in Next Generation Sequencing 204

9. Company Profiles 205
9.1 Abbott Molecular Diagnostics 205
9.2 Accugenomics, Inc. 205
9.3 Agendia 206
9.4 Ambry Genetics 207
9.5 Biodesix 207
9.6 bioMérieux 207
9.7 bioTheranostics (AviaraDx) 207
9.8 Cancer Genetics, Inc. 208
9.9 Clarient, Inc. (GE Healthcare) 209
9.10 Counsyl 210
9.11 Flatiron Health 211
9.12 Epigenomics 211
9.13 Exact Sciences Corporation 212
9.14 Exiqon 212
9.15 Genomic Health, Inc. 213
9.16 Genoptix, Inc. (Novartis) 214
9.17 Genmark Diagnostics 214
9.18 Genomictree 215
9.19 HTG Molecular Diagnostics 215
9.20 Invitae 216
9.21 LabCorp 217
9.22 Myriad Genetics, Inc. 217
9.23 Nanostring 220
9.24 Neogenomics 221
9.25 NSTG 221
9.26 Nuvera Biosciences 222
9.27 Orion Genomics 222
9.28 Pathway Genomics 222
9.29 Personal Genome Diagnostics 222
9.30 Quest Diagnostics 223
9.31 Rosetta Genomics Ltd. 223
9.32 Signal Genetics 224
9.33 Source MDx 225
9.34 Wilex, Inc. 225
Appendix 1: Definition of Terms for Molecular Diagnostics 226
Appendix 2: Standard Cancer Therapeutic Panels 228

List of Tables

Table 2.1: Genes and Cancer Risk 21
Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 25
Table 2.3: Targeted Drug Therapies for Cancers 26
Table 2.4: Use of Cancer Biomarkers in Drug Development 29
Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development 30
Table 2.6: FDA Approved Companion Diagnostics 30
Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2011-2021 35
Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2011-2021 35
Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2014 36
Table 3.4: Key Diagnostic Product Companies in the Global Molecular Diagnostics Cancer Testing Market 37
Table 3.5: Key Laboratory Testing Companies in the Global Molecular Diagnostics Cancer Testing Market 38
Table 3.6: Business Factors Influencing Advanced Oncology Testing Services 39
Table 3.7: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 40
Table 3.8: Highlights of the Cancer Diagnostic Testing Segment 41
Table 3.9: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services 41
Table 3.10: Strategies for Marketing Cancer Diagnostic Products 44
Table 3.11: Key Elements of MDx Diagnostic Companies Marketing Plan 45
Table 4.1: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2014 47
Table 4.2: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2014 48
Table 4.3: Emerging Molecular Diagnostic Technologies 51
Table 4.4: Key Elements for Business Competition in Gene Expression Profiling for Cancer 53
Table 4.5: FDA Approved Cancer Tests 54
Table 4.6: Breast Cancer Overview 56
Table 4.7: Overview of ER/PR Testing and Response to Therapy 57
Table 4.8: Key Players in the Breast Cancer Molecular Diagnostic Space 58
Table 4.9: Commercially Available Molecular Diagnostic Laboratory Services for Breast Cancer Assay 58
Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX 60
Table 4.11: Oncotype DX Overview 60
Table 4.12: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 61
Table 4.13: Overview of HER2/neu and Herceptin 64
Table 4.14: MammaPrint: Key Features 69
Table 4.15: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2014 73
Table 4.16: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2014 74
Table 4.17: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2014 75
Table 4.18: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2015-2021 77
Table 4.19: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2015-2021 77
Table 4.20: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 77
Table 4.21: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 78
Table 4.22: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market 79
Table 4.23: Colorectal Cancer Overview 81
Table 4.24: KRAS Mutation Assay 82
Table 4.25: KRAS Assays by Analytical Type 83
Table 4.26: KRAS Mutation Analysis Summary 83
Table 4.27: DxS KRAS Mutation Test Summary 84
Table 4.28: KRAS and BRAF in Clinical Use 84
Table 4.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space 85
Table 4.30: NexCourse CRC Test Offering and Treatment Direction 91
Table 4.31: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2014 92
Table 4.32: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2014 93
Table 4.33: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2015-2021 94
Table 4.34: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2015-2021 94
Table 4.35: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 94
Table 4.36: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 95
Table 4.37: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 97
Table 4.38: Stages in Prostate Cancer Discovery and Diagnosis 98
Table 4.39: Corporate Players Entering the Prostate Cancer Molecular Diagnostic Space 99
Table 4.40: Hologic Genetic Testing Product Line 103
Table 4.41: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 109
Table 4.42: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 110
Table 4.43: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer Molecular Diagnostic Market 110
Table 4.44: Players in the Bladder Cancer Molecular Diagnostic Space 113
Table 4.45: Commercially Available Molecular Diagnostic Products for Ovarian Cancer Assay 118
Table 4.46: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2014 119
Table 4.47: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2014 119
Table 4.48: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2015-2021 121
Table 4.49: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2015-2021 121
Table 4.50: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 121
Table 4.51: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 122
Table 4.52: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market 123
Table 4.53: Lung Cancer Survival Rates 123
Table 4.54: Lung Cancer Facts 124
Table 4.55: Pharmacogenetic Markers for Select Cancer Drugs 128
Table 4.56: Potential of Cancer Biomarkers in Drug Delivery and Development 132
Table 4.57: Barriers to Adoption of Biomarkers in Clinical Use 132
Table 5.1: Technology Trends in Cancer Testing 136
Table 5.2: Trends in Theranostics 137
Table 5.3: Market Trends in Cancer Testing 138
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 138
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 138
Table 5.6: Companies that Offer Products to Profile Gene Expression in Breast Cancer 150
Table 5.7: Principal Competitive Factors in the Cancer Screening Market 150
Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 151
Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 152
Table 5.10: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges 152
Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development 168
Table 6.1: CPT Codes for Tumor Markers 174
Table 6.2: Genomic Health Oncotype DX Sales, 2006-2014 177
Table 6.3: Factors Determining Third-Party Payment for Advanced Cancer Tests 180
Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business 184
Table 7.2: Focus Areas for the FDA Critical Path Initiative 190
Table 8.1: Effect of Regulation on MDx Cancer Market Technology Platforms, 2007 and 2015 194
Table 8.2: Partnerships Between Pharmaceutical and Diagnostic Companies, 2009-Present 201
Table 9.1: Clarient Molecular/PCR Tests 210

List of Figures

Figure 2.1: Finding Genes with Microassays 18
Figure 2.2: Use of Microassays for Studying Gene Expression 18
Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 19
Figure 2.4: Microarrays for Prediction of Survival in Cancer 21
Figure 2.5: Finding New Drugs with Microarrays 26
Figure 2.6: Using Gene Expression Patterns to Chose Treatment 26
Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2014 36
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing in the U.S., 2014 36
Figure 3.3: Market Share for Key Companies in Global Molecular Diagnostics Cancer Testing Market 37
Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers 44
Figure 4.1: Using DNA Microassays to Measure Gene Expression 49
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 50
Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy 63
Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 65
Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 65
Figure 4.6: Action of Herceptin in Breast Cancer Patients 66
Figure 4.7: Analysis of Cancer Tissue by Microarray 68
Figure 4.8: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2014 75
Figure 4.9: Incidence of CRC by Age Group 80
Figure 4.10: HNPCC Mutation Increases Risk of Cancer 89
Figure 4.11: APC Mutation Increases Risk of Cancer 90
Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2014 93
Figure 4.13: Prostate-Specific Membrane Antigen 99
Figure 4.14: PCA3 Score Nomogram 101
Figure 4.15: Estimates for PCA3 Test Volume in the U.S., 2005-2012 102
Figure 4.16: Ovarian Cancer Types 115
Figure 4.17: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2014 120
Figure 5.1: FDA Co-Developed Products as a Model for Collaboration 144
Figure 5.2: Segmentation of the Biomarker Development Market 166
Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2011 177
Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 191

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