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Aarkstore Enterprise - Molecular Diagnostics in

Cancer Testing






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.
16
th
September 2014


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Cancer-Testing
Published: Nov 2013 No. Of Pages: 232 Pages
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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 16
2.1 Opening of Opportunities in Molecular Diagnostics 16
2.2 Impact of the Human Genome Project on Molecular Diagnostics 18
2.3 Considerations for Molecular and Clinical Diagnostics 18
2.4 Molecular Diagnostics in the Post-Genomic Era 21
2.5 Advances in Molecular Diagnostics Technologies 22
2.6 Oligonucleotide Array Platforms 24
2.7 Emerging Cancer Personalized Medicine Market 24
2.7.1 Predictive Cancer Molecular Diagnostics 26
2.8 Companion Tests for Drug Development 27
2.9 Opportunities for IVDMIA Companies 29

3. Cancer Diagnostics Molecular Testing Market 30
3.1 Market Description 34
3.1.1 Market Overview 34
3.1.2 Molecular Diagnostic Markers 35
3.1.3 Competitive Landscape 36
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3.1.4 Sales and Marketing Strategies for Cancer Tests 38

4. Molecular Diagnostic Tests for Cancer 42
4.1 Cancer Diagnostic Tests 42
4.1.1 Use of Genomics to Understand Cancer 43
4.1.2 Molecular Diagnostic Tools Solutions 45
4.1.3 Technology of Gene Expression Analysis 47
4.2 Breast Cancer 49
4.2.1 Cancer Prognostic Assays 51
4.2.2 Competition and Comparison of Methods 65
4.2.3 Competitive Structure and Market Share Analysis 66
4.3 Colorectal Cancer Molecular Diagnostics Market 71
4.3.1 Colon Cancer Testing Platforms 73
4.3.2 Players in the Colorectal Cancer Space 79
4.3.3 Competitive Structure and Market Share Analysis 85
4.4 Prostate Cancer Molecular Diagnostics Market 91
4.4.1 Screening for Prostate Cancer 91
4.4.2 Tests after Positive Biopsy 97
4.4.3 Tests After Negative Biopsy 99
4.4.4 Tests After Surgery 100
4.4.5 Competition and Comparison of Methods 100
4.4.6 Competitive Structure and Market Share Analysis 101
4.4.7 Market Drivers and Restraints 102
4.4.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 103
4.5 Other Cancer Molecular Diagnostic Markets 106
4.5.1 Bladder Cancer 106
4.5.2 Ovarian Cancer 107
4.5.3 Lung Cancer 118
4.5.4 Melanoma 124
4.6 Molecular Diagnostic Screening Test for Cancer 125
4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay) 126
4.6.2 Multidrug Resistance Protein 127
4.7 Companion Diagnostic Tests for Cancer Therapeutics 127


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5. Business 131
5.1 Technology and Market Trends 131
5.1.1 Technology Trends 132
5.1.2 Market Trends 133
5.2 M&A Activity 135
5.3 Partnerships 138
5.4 Competitive Analysis 141
5.4.1 Primary Competitors 147
5.4.2 Industry Challenges and Strategic Recommendations 149
5.4.3 Commercialization of Molecular Diagnostic Products 149
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 151
5.6 Intellectual Property Rights 167
5.6.1 BRCA1 and BRCA2 Gene Patents 168
5.6.2 Current Patent Disputes 168

6. Reimbursement and Billing 169
6.1 Overview 169
6.2 Trends in Reimbursement Practice 169
6.2.1 Medicare Reimbursement 170
6.2.2 Analysis of ROI for MDx Tests for Cancer Using Medicare Reimbursement Rules 173
6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 174
6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms 174
6.3 Breast Cancer Tests 174
6.4 Colon Cancer Tests 176
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

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7.2 CLIA Regulations 185
7.3 Clinical Laboratory Improvement Act 186
7.4 State Licensing for Service Laboratories 187
7.5 FDA Treatment of Multivariate Index Assays 188
7.6 510(k) Clearance 189
7.7 Pre-Market Approval 189
7.8 ASRs 189
7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 190
7.10 U.S. Patent and Trademark Office 191
7.11 IRB Approval in Clinical Trials 191
7.12 Oncology Biomarkers Qualification Initiative Project 191
7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX 192
7.14 FDA Packaging Requirements for Erbitux 192
7.15 Microarray Quality Control 192
7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing 193
7.17 ER and PR Proficiency Testing 193

8. Business Decisions Using Molecular Diagnostic Tests in Cancer Test Development 194
8.1 What are the Key Opportunities for Development of Cancer Tests Based Upon Molecular
Diagnostics Technologies? 194
8.2 What are the Current Obstacles for MDx Cancer Testing Implementation? 194
8.3 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker
Strategies? 195
8.4 Which Types of Cancer MDx Testing should be Developed by Diagnostic Companies at
Various Stages in the Development Pipeline? 195
8.5 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 195
8.6 What are the Noteworthy Deals? 196
8.7 Who are the Acquirers? 197
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

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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 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 204

9. Company Profiles 205
9.1 Agendia 205
9.2 ArcticDx, Inc. 205
9.3 Biodesix 206
9.4 bioTheranostics (AviaraDx) 206
9.5 Cancer Genetics, Inc. 207
9.6 Clarient, Inc. (GE Healthcare) 208
9.7 CombiMatrix Corporation 208
9.8 Epigenomics 209
9.9 Exact Sciences Corporation 210
9.10 Exagen Diagnostics, Inc. 210
9.11 Exiqon 211
9.12 Ferrer inCode 211
9.13 Genomic Health, Inc. 211
9.14 Genoptix, Inc. 212
9.15 InterGenetics, Inc. 213
9.16 LabCorp 213
9.17 Myriad Genetics, Inc. 213

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9.18 Nanostring 215
9.19 Neogenomics 215
9.20 Nuvera Biosciences 215
9.21 Orion Genomics 216
9.22 QIAGEN NV 216
9.23 Rosetta Genomics Ltd. 217
9.24 Seegene 217
9.25 Sequenom, Inc. 217
9.26 SABiosciences Corporation (Qiagen) 218
9.27 Source MDx 218
9.28 Targeted Molecular Diagnostics 219

Appendix 1: Definition of Terms for Molecular Diagnostics 220
Appendix 2: Standard Cancer Therapeutic Panels 222
Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize Cancer 225
Appendix 4: Technical Assessment of the Kirsten RNA Associated Rat Sarcoma 2 Virus Gene
(KRAS) KRAS Mutation Test by Several Methodologies and Specialty Oncology Laboratories 227
Appendix 5: Overview of Microarrays 229


List of Tables

Table 2.1: Genes and Cancer Risk 20
Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 25
Table 2.3: Targeted Drug Therapies for Cancers 25
Table 2.4: Use of Cancer Biomarkers in Drug Development 28
Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development 28
Table 2.6: Time Line for Development of Companion Diagnostics 29
Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2008-2018 30
Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2018 30
Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2012 31
Table 3.4: Key Diagnostic Companies in the Global Molecular Diagnostics Cancer Testing Market
32

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Table 3.5: Key Laboratory Testing Companies in the Global Molecular Diagnostics Cancer
Testing Market 32
Table 3.6: Business Factors Influencing Advanced Oncology Testing Services 33
Table 3.7: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 34
Table 3.8: Highlights of the Cancer Diagnostic Testing Segment 35
Table 3.9: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular
Diagnostic
Services 35
Table 3.10: Strategies for Marketing Cancer Diagnostic Products 39
Table 3.11: Key Elements of MDx Diagnostic Companies Marketing Plan 40
Table 4.1: Estimates for the Leading Sites of New Cancer Cases in the U.S. by Gender, 2013 42
Table 4.2: Estimates for the Leading Sites of Cancer Deaths in the U.S. by Gender, 2013 42
Table 4.3: Emerging Molecular Diagnostic Technologies 46
Table 4.4: Key Elements for Business Competition in Gene Expression Profiling for Cancer 48
Table 4.5: Key Elements for Future Success in the Gene Profiling for Cancer Segment 48
Table 4.6: Companies Marketing Products in the Cancer Molecular Diagnostics Sector 49
Table 4.7: Breast Cancer Overview 50
Table 4.8: Overview of ER/PR Testing and Response to Therapy 51
Table 4.9: Key Players in the Breast Cancer Molecular Diagnostic Space 52
Table 4.10: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay 52
Table 4.11: Clinical Utility and Health Economic Benefits of Oncotype DX 54
Table 4.12: Oncotype DX Overview 54
Table 4.13: Comparison of Agendia vs. Genomic Health Breast Cancer Tests 55
Table 4.14: Overview of HER2/neu and Herceptin 58
Table 4.15: MammaPrint: Key Features 63
Table 4.16: Oncogene Science Biomarker Group Reagents 64
Table 4.17: Major Laboratory Testing Companies Marketing Breast Cancer Molecular Diagnostic
Tests, 2012 66
Table 4.18: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012 67
Table 4.19: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2012 68
Table 4.20: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018
69
Table 4.21: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2013-2018 69

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Table 4.22: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order
of Impact 69
Table 4.23: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in
Order of Impact 70
Table 4.24: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer
Molecular Diagnostic Market 71
Table 4.25: Colorectal Cancer Overview 73
Table 4.26: KRAS Mutation Assay 74
Table 4.27: KRAS Assays by Analytical Type 75
Table 4.28: KRAS Mutation Analysis Summary 75
Table 4.29: DxS KRAS Mutation Test Summary 76
Table 4.30: KRAS and BRAF in Clinical Use 77
Table 4.31: Product Development Opportunities in Cancer Tumor Types, 2008 78
Table 4.32: Key Players in the Colorectal Cancer Molecular Diagnostic Space 79
Table 4.33: ArcticDx Genetic Test, Colo Risk 82
Table 4.34: NexCourse CRC Test Offering and Treatment Direction 84
Table 4.35: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012 85
Table 4.36: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2012 86
Table 4.37: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2013-2018
87
Table 4.38: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2018 87
Table 4.39: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order
of Impact 87
Table 4.40: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in
Order of Impact 88
Table 4.41: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer
Market 90
Table 4.42: Stages in Prostate Cancer Discovery and Diagnosis 91
Table 4.43: Corporate Players Entering the Prostate Cancer Molecular Diagnostic Space 92
Table 4.44: Gen-Probe Genetic Testing Product Line 96
Table 4.45: Prostate Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in
Order of Impact 102
Table 4.46: Prostate Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in
Order of

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Impact 102
Table 4.47: Summary of Strengths, Weaknesses, Opportunities and Threats of the Prostate Cancer
Molecular Diagnostic Market 103
Table 4.48: Players in the Bladder Cancer Molecular Diagnostic Space 106
Table 4.49: Clinical Applications of Serum Biomarkers for Ovarian Cancer 108
Table 4.50: Commercially Available Molecular Diagnostic Products for Ovarian Cancer Assay
114
Table 4.51: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2012 114
Table 4.52: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2012 115
Table 4.53: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2013-2016
116
Table 4.54: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2013-2016
116
Table 4.55: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of
Impact 116
Table 4.56: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of
Impact 117
Table 4.57: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer
Market 118
Table 4.58: Lung Cancer Survival Rates 118
Table 4.59: Lung Cancer Facts 119
Table 4.60: Pharmacogenetic Markers for Select Cancer Drugs 123
Table 4.61: Potential of Cancer Biomarkers in Drug Delivery and Development 128
Table 4.62: Barriers to Adoption of Biomarkers in Clinical Use 128
Table 5.1: Technology Trends in Cancer Testing 132
Table 5.2: Trends in Theranostics 133
Table 5.3: Market Trends in Cancer Testing 134
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 134
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact
135
Table 5.6: Companies That Offer Products to Profile Gene Expression in Breast Cancer 147
Table 5.7: Principal Competitive Factors in the Cancer Screening Market 147
Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of
Care Market 148

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Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular
Diagnostic Sector Business Functions 149
Table 5.10: Total U.S. Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges
149
Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development 166
Table 6.1: CPT Codes for Tumor Markers 172
Table 6.2: Genomic Health Oncotype DX Sales, 2006-2012 175
Table 6.3: Drivers in KRAS Testing 177
Table 6.4: 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 191
Table 8.1: Effect of Regulation on MDx Cancer Market Technology Platforms, 2007 and 2015 195
Table 8.2: Partnerships Between Pharmaceutical and Diagnostic Companies, 2009-Present 201
Table A2.1: Serum Tumor Markers Currently in Common Use 224


List of Figures

Figure 2.1: Finding Genes with Microassays 17
Figure 2.2: Use of Microassays for Studying Gene Expression 17
Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 18
Figure 2.4: Microarrays for Prediction of Survival in Cancer 20
Figure 2.5: Finding New Drugs with Microarrays 25
Figure 2.6: Using Gene Expression Patterns to Chose Treatment 26
Figure 2.7: Segmentation of the Biomarker Development Market 27
Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2012 31
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing U.S., 2012 31
Figure 3.3: Market Share for Key Companies in Global Molecular Diagnostics Cancer Testing
Markets 32
Figure 3.4: Market Growth and Evolution of MDx Cancer Biomarkers 39
Figure 4.1: Using DNA Microassays to Measure Gene Expression 44
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 44
Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy 58

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Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with
IHC 59
Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 59
Figure 4.6: Action of Herceptin in Breast Cancer Patients 60
Figure 4.7: Analysis of Cancer Tissue by Microarray 62
Figure 4.8: Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2012 67
Figure 4.9: Incidence of CRC by Age Group 72
Figure 4.10: HNPCC Mutation Increases Risk of Cancer 83
Figure 4.11: APC Mutation Increases the Risk of Cancer 83
Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2012 86
Figure 4.13: Prostate-Specific Membrane Antigen 92
Figure 4.14: PCA3 Score Nomogram 94
Figure 4.15: Estimates for PCA3 Test Volume in the U.S., 2005-2012 95
Figure 4.16: Ovarian Cancer Types 107
Figure 4.17: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2012 115
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 139
Figure 5.2: Segmentation of the Biomarker Development Market 165
Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2011 174
Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 192

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