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.TABLE OF CONTENTS1. Overview 8
1.1 Statement of Report 8
1.2 About This Report 8
1.3 Scope of the Report 9
1.4 Objectives 9
1.5 Methodology 10
1.6 Executive Summary 112. Introduction to Molecular Diagnostics 15
2.1 Opening-up of Opportunities in Molecular Diagnostics 15
2.2 Impact of the Human Genome Project on Molecular Diagnostics 17
2.3 Considerations for Molecular and Clinical Diagnostics 17
2.4 Molecular Diagnostics in the Post-Genomic Era 20
2.5 Advances in Molecular Diagnostics Technologies 21
2.6 Oligonucleotide Array Platforms 23
2.7 Emerging Cancer Personalized Medicine Market 23
2.7.1 Predictive Cancer Molecular Diagnostics 25
2.8 Companion Tests for Drug Development 26
2.9 Opportunities for IVDMIA Companies 283. Cancer Diagnostics Molecular Testing Market 29
3.1 Market Description 33
3.1.1 Market Overview 33
3.1.2 Tumor Markers 34
3.1.3 Molecular Diagnostic Markers 40
3.1.4 Competitive Landscape 41
3.1.5 Sales and Marketing Strategies for Cancer Tests 44
3.1.5.1 North American Market 45
3.1.5.2 International Markets 46
3.1.5.3 Europe 46
3.1.5.4 Asia-Pacific 474. Molecular Diagnostic Tests for Cancer 48
4.1 Cancer Diagnostic Tests 48
4.1.1 Use of Genomics to Understand Cancer 49
4.1.2 Molecular Diagnostic Tools Solutions 51
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 54
4.2 Breast Cancer 55
4.2.1 Cancer Prognostic Assays 57
4.2.1.1 Myriad Genetics (BRACA1 and BRACA2) 58
4.2.1.2 Genomic Health (Oncotype DX) 58
4.2.1.2.1 Single Gene Reporting (ER, PR, HER2) 60
4.2.1.2.2 Node Positive (N+) 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) 62
4.2.1.5 Clarient, Inc. 64
4.2.1.6 BioTheronostics (AviaraDx) 65
4.2.1.7 Agendia B.V. (MammaPrint) 65
4.2.1.8 Oncogene Science (Wilex) 67
4.2.2 Competition and Comparison of Methods 69
4.2.3 Competitive Structure and Market Share Analysis 69
4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 70
4.2.3.1.1 Global Market 70
4.2.3.1.2 U.S. Market 71
4.2.3.1.3 European Market 71
4.2.3.2 Market Forecasts 72
4.2.3.2.1 Revenue Forecasts 72
4.2.3.3 Market Drivers and Restraints 73
4.2.3.3.1 Market Drivers 73
4.2.3.3.2 Market Restraints 73
4.2.3.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 73
4.2.3.4.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 73
4.2.3.4.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 74
4.2.3.4.3 Breast Cancer Testing Assay Strategic Recommendations 74
4.3 Colorectal Cancer Molecular Diagnostics Market 75
4.3.1 Colon Cancer Testing Platforms 76
4.3.1.1 Genomic Testing 76
4.3.1.1.1 IVD Multiplex Index Analysis (MIA) 76
4.3.1.1.2 The BRAF Test 77
4.3.1.1.3 KRAS 77
4.3.1.1.3.1 Background on KRAS Mutation 77
4.3.1.1.4 mSEPT9 81
4.3.1.2 Screening Test 81
4.3.2 Players in the Colorectal Cancer Space 82
4.3.3 Competitive Structure and Market Share Analysis 88
4.3.3.1 Colon Cancer Molecular Diagnostic Testing Market Size 89
4.3.3.1.1 Global Colon Cancer testing Market 89
4.3.3.1.2 U.S. Colon Cancer testing Market 89
4.3.3.1.3 European Colon Cancer testing Market 90
4.3.3.2 Market Forecasts 90
4.3.3.2.1 Revenue Forecasts 90
4.3.3.3 Market Drivers and Restraints 91
4.3.3.3.1 Market Drivers 91
4.3.3.3.2 Market Restraints 91
4.3.3.4 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 91
4.3.3.4.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 91
4.3.3.4.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 92
4.3.3.4.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 92
4.4 Prostate Cancer Molecular Diagnostics Market 94
4.5 Other Cancer Molecular Diagnostic Markets 100
4.5.1 Bladder Cancer 100
4.5.2 Ovarian Cancer 101
4.5.2.1 Incidence of Ovarian Cancer 101
4.5.2.2 Key Players in Ovarian Testing market 102
4.5.2.3 Ovarian Cancer Market Size 103
4.5.2.4 Ovarian Cancer Molecular Diagnostic Testing Market Size 104
4.5.2.4.1 Global Ovarian Cancer testing Market 104
4.5.2.4.2 U.S. Ovarian Cancer testing Market 104
4.5.2.4.3 European Ovarian Cancer testing Market 105
4.5.2.5 Market Forecasts 105
4.5.2.5.1 Revenue Forecasts 105
4.5.2.6 Market Drivers and Restraints 106
4.5.2.6.1 Market Drivers 106
4.5.2.6.2 Market Restraints 106
4.5.2.7 Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 106
4.5.2.7.1 Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends 106
4.5.2.7.2 Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends 106
4.5.2.7.3 Ovarian Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 107
4.5.3 Lung Cancer 107
4.5.4 Melanoma 113
4.6 Molecular Diagnostic Screening Test for Cancer 114
4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay) 115
4.6.2 Multidrug Resistance Protein (MRP) 115
4.7 Companion Diagnostic Tests for Cancer Therapeutics 1165. Business 119
5.1 Technology and Market Trends 119
5.1.1 Technology Trends 120
5.1.2 Market Trends 121
5.2 M&A Activity 123
5.3 Partnerships 125
5.4 Competitive Analysis 127
5.4.1 Primary Competitors 127
5.4.1.1 Summary of Market Strengths, Weaknesses, Opportunities and Threats 129
5.4.2 Industry Challenges and Strategic Recommendations 130
5.4.3 Commercialization of Molecular Diagnostic Products 130
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 132
5.6 Intellectual Property Rights 148
5.6.1 BRCA1 and BRCA2 Gene Patents 149
5.6.2 Current Patent Disputes 1506. Reimbursement and Billing 151
6.1 Overview 151
6.2 Trends in Reimbursement Practice 151
6.2.1 Medicare Reimbursement 152
6.2.2 Analysis of ROI for MD Tests for Cancer Using Medicare Reimbursement Rules 155
6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 156
6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms 156
6.3 Breast Cancer Tests 156
6.4 Colon Cancer Tests 157
6.5 Trends in Patient Care and Reimbursement 159
6.6 Revenue Threats 161
6.6.1 Medicare Exceptions 162
6.6.2 Three Areas for Denial of Claims by Biomarkers 162
6.7 Billing 163
6.7.1 Medicare Billing Procedures 163
6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers 1647. Government Regulation 166
7.1 U.S. Food and Drug Administration 166
7.2 CLIA Regulations 167
7.3 Clinical Laboratory Improvement Act (CLIA) 168
7.4 State Licensing for Service Laboratories 169
7.5 FDA Treatment of Multivariate Index Assays (IVDMIAs) 170
7.6 510(k) Clearance 171
7.7 Pre-Market Approval (PMA) 171
7.8 ASRs 172
7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 172
7.10 U.S. Patent and Trademark Office (USPTO) 173
7.11 IRB Approval in Clinical Trials 173
7.12 Oncology Biomarkers Qualification Initiative Project 173
7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX 174
7.14 FDA Packaging Requirements for Erbitux 174
7.15 Micoarray Quality Control (MAQC) 174
7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing 175
7.17 ER and PR Proficiency Testing 176
8. Business Decisions Using Molecular Diagnostic Tests in Drug Development 177
8.1 Advantages of a Pharmacogenomic Assessment of Genetic Biomarkers to Determine
Clinical Dose 177
8.2 What are Key Opportunities in Biomarker Discovery, Development and Commercialization? 177
8.3 What are the Current Obstacles in Biomarker Implementation? 177
8.4 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies? 178
8.5 What is the Right Balance between External Partnerships and Internal Infrastructure? 178
8.6 How might Novel Biomarker Development Lead to Acquisition Strategies? 178
8.7 Which Types of Genetic Biomarkers should be Developed by Diagnostic Companies? 178
8.8 What Strategies Help Translate Genetic biomarkers from Preclinical to Clinical Development? 178
8.9 In what Class of Drugs is the Value of Using Genetic biomarkers in Decision making the Highest? 179
8.10 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 180
8.11 How can Big Pharma Co-develop Genetic Biomarkers for Regulatory Acceptance? 180
8.12 How are Genetic Biomarkers being Used to reduce the Attrition Rate in Drug Development? 180
8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development? 180
8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and How Should R&D Organizations Address This Problem? 180
8.15 How to Maximize Business Development through Biomarker Strategies? 181
8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers? 181
8.17 What are Organizational Impediments in Genetic Biomarkers in Drug Development? 181
8.18 What are Internal Capabilities for Novel Biomarker Development and Application? 181
8.19 How can Key Biomarker Technical Expertise be Applied across a Complex and Highly-Stratified R&D Value Chain? 182
8.20 At what Stage of Drug Development have Genetic Biomarkers Provided the Most Benefit? 182
8.21 What Companies are the most Innovative in Development of Genetic Biomarkers? 182
8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics 182
8.23 Molecular Diagnostic Tests can Increase Value in an Associated Drug 183
9. Company Profiles 184
9.1 Agendia 184
9.2 ArcticDx, Inc. 184
9.3 Arcxis Biotechnologies 184
9.4 Aureon Laboratories 185
9.5 bioTheranostics (AviaraDx) 185
9.6 Clarient, Inc. 186
9.7 CombiMatrix Corporation 186
9.8 DiagnoCure 187
9.9 Epigenomics 187
9.10 Exact Sciences Corporation 187
9.11 Exagen Diagnostics, Inc. 187
9.12 Exiqon 187
9.13 Ferrer inCode 188
9.14 Genomic Health, Inc. 188
9.15 Genoptix, Inc. 189
9.16 Gen-Probe 189
9.17 InterGenetics, Inc. 190
9.18 LabCorp 190
9.19 Myriad Genetics, Inc. 191
9.20 Nuvera Biosciences 191
9.21 Orion Genomics 192
9.22 QIAGEN NV 192
9.23 Rosetta Genomics Ltd. 193
9.24 Seegene 193
9.25 Sequenom, Inc. 193
9.26 SABiosciences Corporation 194
9.27 Source MDx 194
9.28 Targeted Molecular Diagnostics 194
9.29 Xenomics, Inc. 194Appendix 1: Definition of Terms for Molecular Diagnostics 196
Appendix 2: Standard Cancer Therapeutic Panels 198
Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize Cancer 201
Appendix 4: Technical Assessment of the KRAS Mutation Test by Several Methodologies and Specialty Oncology Laboratories 203
Appendix 5: Overview of Microarrays 205LIST OF FIGURESFigure 2.1: Finding Genes with Microassays 16
Figure 2.2: Use of Microassays for Studying Gene Expression 16
Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 17
Figure 2.4: Microarrays for Prediction of Survival in Cancer 19
Figure 2.5: Finding New Drugs with Microarrays 24
Figure 2.6: Using Gene Expression Patterns to Chose Treatment 25
Figure 2.7: Segmentation of the Biomarker Development Market 26
Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2010 30
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing U.S., 2010 30
Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Cancer Testing Markets 31
Figure 3.4: Market Growth and Evolution of MD Cancer Biomarkers 44
Figure 4.1: Using DNA Microassays to Measure Gene Expression 50
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 62
Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 63
Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 63
Figure 4.6: Action of Herceptin in Breast Cancer Patients 64
Figure 4.7: Analysis of Cancer Tissue by Microarray 66
Figure 4.8 Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2010 71
Figure 4.9 Incidence of CRC by Age Group 76
Figure 4.10 HNPCC Mutation Increases Risk of Cancer 86
Figure 4.11 APC Mutation Increases the Risk of Cancer 87
Figure 4.12 U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2010 89
Figure 4.13 Prostate-Specific Membrane Antigen 95
Figure 4.14 Estimates for PCA3 Test Volume in U.S., 2005-2008 97
Figure 4.15 U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2010 104
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 126
Figure 5.2: Segmentation of the Biomarker Development Market 146
Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2006 156
Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 174
Figure 8.1: Discovery, Validation and Use of Genetic Biomarkers 179LIST OF TABLESTable 2.1: Genes and Cancer Risk 19
Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 24
Table 2.3: Targeted Drug Therapies for Cancers 24
Table 2.4: Use of Cancer Biomarkers in Drug Development 27
Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development 27
Table 2.6: Time Line for Development of Companion Diagnostics 28
Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2008-2016 29
Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2016 29
Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2010 30
Table 3.4: Key Players and Market Share in Global Molecular Diagnostics Cancer Testing Market 31
Table 3.5: Business Factors Influencing Advanced Oncology Testing Services 32
Table 3.6: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 33
Table 3.7: In Vitro Cancer BioMarker Market Segments Worldwide, 2007 and 2010 34
Table 3.8: Tumor Markers Currently in Common Use 36
Table 3.9: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates 37
Table 3.10: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market,
2001-2010 37
Table 3.11: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 38
Table 3.12: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 38
Table 3.13: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 39
Table 3.14: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 39
Table 3.15: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 39
Table 3.16: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing 40
Table 3.17: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market 40
Table 3.18: Major Presence in Cancer Tumor Marker Diagnostics Markets 40
Table 3.19: Highlights of the Cancer Diagnostic Testing Segment 41
Table 3.20: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services 41
Table 3.21: Strategies for Marketing Cancer Diagnostic Products 45
Table 3.22: Key Elements of MD Diagnostic Companies Marketing Plan 45
Table 4.1: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Gender 48
Table 4.2: Emerging Molecular Diagnostic Technologies 52
Table 4.3: Key Elements for Business Competition in Gene Expression Profiling for Cancer 54
Table 4.4: Key Elements for Future Success in the Gene Profiling for Cancer Segment 54
Table 4.5: Companies Marketing Products in the Cancer Molecular Diagnostics Sector 55
Table 4.6: Breast Cancer Overview 56
Table 4.7: Overview of ER/PR Testing and Response to Therapy 56
Table 4.8: Key Players in the Breast Cancer Molecular Diagnostic Space 57
Table 4.9: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay 58
Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX 60
Table 4.11: Overview of HER2/neu and Herceptin 62
Table 4.12: MammaPrint: Key Features 67
Table 4.13: Oncogene Science Biomarker Group Reagents 68
Table 4.14: Major Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2010 70
Table 4.15: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2010 70
Table 4.16: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2010 71
Table 4.17: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2011-2016 72
Table 4.18: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2011-2016 72
Table 4.19: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in
Order of Impact 73
Table 4.20: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in
Order of Impact 73
Table 4.21: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market 74
Table 4.22: Colorectal Cancer Overview 76
Table 4.23: KRAS Mutation Assay 77
Table 4.24: KRAS Assays by Analytical Type 78
Table 4.25: KRAS Mutation Analysis Summary 79
Table 4.26: DxS KRAS Mutation Test Summary 79
Table 4.27: KRAS and BRAF in Clinical Use 81
Table 4.28: Product Development Opportunities in Cancer Tumor Types, 2008 81
Table 4.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space 82
Table 4.30: ArcticDx Genetic Test, Colo Risk 85
Table 4.31: NexCourse CRC Test Offering and Treatment Direction 87
Table 4.32: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2010 89
Table 4.33: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2010 89
Table 4.34: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2011-2016 90
Table 4.35: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2016 90
Table 4.36: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in
Order of Impact 91
Table 4.37: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in
Order of Impact 91
Table 4.38: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 93
Table 4.39: Players in the Prostate Cancer Molecular Diagnostic Space 95
Table 4.40: Players in the Bladder Cancer Molecular Diagnostic Space 100
Table 4.41: Commercially Available Molecular Diagnostic Products for Ovarian Caner Assay 103
Table 4.42: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2010 104
Table 4.43: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2010 104
Table 4.44: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2011-2016 105
Table 4.45: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2010-2016 105
Table 4.46: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 106
Table 4.47: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 106
Table 4.48: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market 107
Table 4.49: Lung Cancer Survival Rates 107
Table 4.50: Lung Cancer Facts 108
Table 4.51: Potential of Cancer Biomarkers in Drug Delivery and Development 117
Table 4.52: Barriers to Adoption of Biomarkers in Clinical Use 117
Table 5.1: Technology Trends in Cancer Testing 120
Table 5.2: Trends in Theranostics 121
Table 5.3: Market Trends in Cancer Testing 122
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 122
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 122
Table 5.6: Companies That Offer Products to Profile Gene Expression in Breast Cancer 128
Table 5.7: Principal Competitive Factors in the Cancer Screening Market 128
Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of
Care Market 129
Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 130
Table 5.10: Total Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges (U.S.) 130
Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development 147
Table 6.1: CPT Codes for Tumor Markers 154
Table 6.2: Genomic Health Oncotype DX Sales, 2006-2010 157
Table 6.3: Drivers in KRAS Testing 159
Table 6.4: Factors Determining Third-Party Payment for Advanced Cancer Tests 161
Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business 166
Table 7.2: Focus Areas for the FDA Critical Path Initiative 173
Table A1: Tumor Markers Currently in Common Use 200Related Market Research Reports :
- Assessment of the Molecular Diagnostic Market for 44 NA Tests in Germany
- Assessment of the Molecular Diagnostic Market for 44 NA Tests in France
- Assessment of the Molecular Diagnostic Market for 44 NA Tests in UK
- Assessment of the Molecular Diagnostic Market for 44 NA Tests in Italy
- Assessment of the Molecular Diagnostic Market for 44 NA Tests in Spain
- Molecular Diagnostics in Infectious Disease Testing
- Assessment of the Molecular Diagnostic Market for Adenovirus NA Tests in Germany
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1.1 Statement of Report 8
1.2 About This Report 8
1.3 Scope of the Report 9
1.4 Objectives 9
1.5 Methodology 10
1.6 Executive Summary 11
2.1 Opening-up of Opportunities in Molecular Diagnostics 15
2.2 Impact of the Human Genome Project on Molecular Diagnostics 17
2.3 Considerations for Molecular and Clinical Diagnostics 17
2.4 Molecular Diagnostics in the Post-Genomic Era 20
2.5 Advances in Molecular Diagnostics Technologies 21
2.6 Oligonucleotide Array Platforms 23
2.7 Emerging Cancer Personalized Medicine Market 23
2.7.1 Predictive Cancer Molecular Diagnostics 25
2.8 Companion Tests for Drug Development 26
2.9 Opportunities for IVDMIA Companies 28
3.1 Market Description 33
3.1.1 Market Overview 33
3.1.2 Tumor Markers 34
3.1.3 Molecular Diagnostic Markers 40
3.1.4 Competitive Landscape 41
3.1.5 Sales and Marketing Strategies for Cancer Tests 44
3.1.5.1 North American Market 45
3.1.5.2 International Markets 46
3.1.5.3 Europe 46
3.1.5.4 Asia-Pacific 47
4.1 Cancer Diagnostic Tests 48
4.1.1 Use of Genomics to Understand Cancer 49
4.1.2 Molecular Diagnostic Tools Solutions 51
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 54
4.2 Breast Cancer 55
4.2.1 Cancer Prognostic Assays 57
4.2.1.1 Myriad Genetics (BRACA1 and BRACA2) 58
4.2.1.2 Genomic Health (Oncotype DX) 58
4.2.1.2.1 Single Gene Reporting (ER, PR, HER2) 60
4.2.1.2.2 Node Positive (N+) 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) 62
4.2.1.5 Clarient, Inc. 64
4.2.1.6 BioTheronostics (AviaraDx) 65
4.2.1.7 Agendia B.V. (MammaPrint) 65
4.2.1.8 Oncogene Science (Wilex) 67
4.2.2 Competition and Comparison of Methods 69
4.2.3 Competitive Structure and Market Share Analysis 69
4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 70
4.2.3.1.1 Global Market 70
4.2.3.1.2 U.S. Market 71
4.2.3.1.3 European Market 71
4.2.3.2 Market Forecasts 72
4.2.3.2.1 Revenue Forecasts 72
4.2.3.3 Market Drivers and Restraints 73
4.2.3.3.1 Market Drivers 73
4.2.3.3.2 Market Restraints 73
4.2.3.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 73
4.2.3.4.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 73
4.2.3.4.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 74
4.2.3.4.3 Breast Cancer Testing Assay Strategic Recommendations 74
4.3 Colorectal Cancer Molecular Diagnostics Market 75
4.3.1 Colon Cancer Testing Platforms 76
4.3.1.1 Genomic Testing 76
4.3.1.1.1 IVD Multiplex Index Analysis (MIA) 76
4.3.1.1.2 The BRAF Test 77
4.3.1.1.3 KRAS 77
4.3.1.1.3.1 Background on KRAS Mutation 77
4.3.1.1.4 mSEPT9 81
4.3.1.2 Screening Test 81
4.3.2 Players in the Colorectal Cancer Space 82
4.3.3 Competitive Structure and Market Share Analysis 88
4.3.3.1 Colon Cancer Molecular Diagnostic Testing Market Size 89
4.3.3.1.1 Global Colon Cancer testing Market 89
4.3.3.1.2 U.S. Colon Cancer testing Market 89
4.3.3.1.3 European Colon Cancer testing Market 90
4.3.3.2 Market Forecasts 90
4.3.3.2.1 Revenue Forecasts 90
4.3.3.3 Market Drivers and Restraints 91
4.3.3.3.1 Market Drivers 91
4.3.3.3.2 Market Restraints 91
4.3.3.4 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 91
4.3.3.4.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 91
4.3.3.4.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 92
4.3.3.4.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 92
4.4 Prostate Cancer Molecular Diagnostics Market 94
4.5 Other Cancer Molecular Diagnostic Markets 100
4.5.1 Bladder Cancer 100
4.5.2 Ovarian Cancer 101
4.5.2.1 Incidence of Ovarian Cancer 101
4.5.2.2 Key Players in Ovarian Testing market 102
4.5.2.3 Ovarian Cancer Market Size 103
4.5.2.4 Ovarian Cancer Molecular Diagnostic Testing Market Size 104
4.5.2.4.1 Global Ovarian Cancer testing Market 104
4.5.2.4.2 U.S. Ovarian Cancer testing Market 104
4.5.2.4.3 European Ovarian Cancer testing Market 105
4.5.2.5 Market Forecasts 105
4.5.2.5.1 Revenue Forecasts 105
4.5.2.6 Market Drivers and Restraints 106
4.5.2.6.1 Market Drivers 106
4.5.2.6.2 Market Restraints 106
4.5.2.7 Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 106
4.5.2.7.1 Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends 106
4.5.2.7.2 Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends 106
4.5.2.7.3 Ovarian Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 107
4.5.3 Lung Cancer 107
4.5.4 Melanoma 113
4.6 Molecular Diagnostic Screening Test for Cancer 114
4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay) 115
4.6.2 Multidrug Resistance Protein (MRP) 115
4.7 Companion Diagnostic Tests for Cancer Therapeutics 116
5.1 Technology and Market Trends 119
5.1.1 Technology Trends 120
5.1.2 Market Trends 121
5.2 M&A Activity 123
5.3 Partnerships 125
5.4 Competitive Analysis 127
5.4.1 Primary Competitors 127
5.4.1.1 Summary of Market Strengths, Weaknesses, Opportunities and Threats 129
5.4.2 Industry Challenges and Strategic Recommendations 130
5.4.3 Commercialization of Molecular Diagnostic Products 130
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 132
5.6 Intellectual Property Rights 148
5.6.1 BRCA1 and BRCA2 Gene Patents 149
5.6.2 Current Patent Disputes 150
6.1 Overview 151
6.2 Trends in Reimbursement Practice 151
6.2.1 Medicare Reimbursement 152
6.2.2 Analysis of ROI for MD Tests for Cancer Using Medicare Reimbursement Rules 155
6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 156
6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms 156
6.3 Breast Cancer Tests 156
6.4 Colon Cancer Tests 157
6.5 Trends in Patient Care and Reimbursement 159
6.6 Revenue Threats 161
6.6.1 Medicare Exceptions 162
6.6.2 Three Areas for Denial of Claims by Biomarkers 162
6.7 Billing 163
6.7.1 Medicare Billing Procedures 163
6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers 164
7.1 U.S. Food and Drug Administration 166
7.2 CLIA Regulations 167
7.3 Clinical Laboratory Improvement Act (CLIA) 168
7.4 State Licensing for Service Laboratories 169
7.5 FDA Treatment of Multivariate Index Assays (IVDMIAs) 170
7.6 510(k) Clearance 171
7.7 Pre-Market Approval (PMA) 171
7.8 ASRs 172
7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 172
7.10 U.S. Patent and Trademark Office (USPTO) 173
7.11 IRB Approval in Clinical Trials 173
7.12 Oncology Biomarkers Qualification Initiative Project 173
7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX 174
7.14 FDA Packaging Requirements for Erbitux 174
7.15 Micoarray Quality Control (MAQC) 174
7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing 175
7.17 ER and PR Proficiency Testing 176
8. Business Decisions Using Molecular Diagnostic Tests in Drug Development 177
8.1 Advantages of a Pharmacogenomic Assessment of Genetic Biomarkers to Determine
Clinical Dose 177
8.2 What are Key Opportunities in Biomarker Discovery, Development and Commercialization? 177
8.3 What are the Current Obstacles in Biomarker Implementation? 177
8.4 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies? 178
8.5 What is the Right Balance between External Partnerships and Internal Infrastructure? 178
8.6 How might Novel Biomarker Development Lead to Acquisition Strategies? 178
8.7 Which Types of Genetic Biomarkers should be Developed by Diagnostic Companies? 178
8.8 What Strategies Help Translate Genetic biomarkers from Preclinical to Clinical Development? 178
8.9 In what Class of Drugs is the Value of Using Genetic biomarkers in Decision making the Highest? 179
8.10 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 180
8.11 How can Big Pharma Co-develop Genetic Biomarkers for Regulatory Acceptance? 180
8.12 How are Genetic Biomarkers being Used to reduce the Attrition Rate in Drug Development? 180
8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development? 180
8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and How Should R&D Organizations Address This Problem? 180
8.15 How to Maximize Business Development through Biomarker Strategies? 181
8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers? 181
8.17 What are Organizational Impediments in Genetic Biomarkers in Drug Development? 181
8.18 What are Internal Capabilities for Novel Biomarker Development and Application? 181
8.19 How can Key Biomarker Technical Expertise be Applied across a Complex and Highly-Stratified R&D Value Chain? 182
8.20 At what Stage of Drug Development have Genetic Biomarkers Provided the Most Benefit? 182
8.21 What Companies are the most Innovative in Development of Genetic Biomarkers? 182
8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics 182
8.23 Molecular Diagnostic Tests can Increase Value in an Associated Drug 183
9. Company Profiles 184
9.1 Agendia 184
9.2 ArcticDx, Inc. 184
9.3 Arcxis Biotechnologies 184
9.4 Aureon Laboratories 185
9.5 bioTheranostics (AviaraDx) 185
9.6 Clarient, Inc. 186
9.7 CombiMatrix Corporation 186
9.8 DiagnoCure 187
9.9 Epigenomics 187
9.10 Exact Sciences Corporation 187
9.11 Exagen Diagnostics, Inc. 187
9.12 Exiqon 187
9.13 Ferrer inCode 188
9.14 Genomic Health, Inc. 188
9.15 Genoptix, Inc. 189
9.16 Gen-Probe 189
9.17 InterGenetics, Inc. 190
9.18 LabCorp 190
9.19 Myriad Genetics, Inc. 191
9.20 Nuvera Biosciences 191
9.21 Orion Genomics 192
9.22 QIAGEN NV 192
9.23 Rosetta Genomics Ltd. 193
9.24 Seegene 193
9.25 Sequenom, Inc. 193
9.26 SABiosciences Corporation 194
9.27 Source MDx 194
9.28 Targeted Molecular Diagnostics 194
9.29 Xenomics, Inc. 194
Appendix 2: Standard Cancer Therapeutic Panels 198
Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize Cancer 201
Appendix 4: Technical Assessment of the KRAS Mutation Test by Several Methodologies and Specialty Oncology Laboratories 203
Appendix 5: Overview of Microarrays 205
Figure 2.2: Use of Microassays for Studying Gene Expression 16
Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 17
Figure 2.4: Microarrays for Prediction of Survival in Cancer 19
Figure 2.5: Finding New Drugs with Microarrays 24
Figure 2.6: Using Gene Expression Patterns to Chose Treatment 25
Figure 2.7: Segmentation of the Biomarker Development Market 26
Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2010 30
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing U.S., 2010 30
Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Cancer Testing Markets 31
Figure 3.4: Market Growth and Evolution of MD Cancer Biomarkers 44
Figure 4.1: Using DNA Microassays to Measure Gene Expression 50
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 62
Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 63
Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 63
Figure 4.6: Action of Herceptin in Breast Cancer Patients 64
Figure 4.7: Analysis of Cancer Tissue by Microarray 66
Figure 4.8 Global Market Size and Share of Breast Cancer Molecular Diagnostic Market, 2010 71
Figure 4.9 Incidence of CRC by Age Group 76
Figure 4.10 HNPCC Mutation Increases Risk of Cancer 86
Figure 4.11 APC Mutation Increases the Risk of Cancer 87
Figure 4.12 U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2010 89
Figure 4.13 Prostate-Specific Membrane Antigen 95
Figure 4.14 Estimates for PCA3 Test Volume in U.S., 2005-2008 97
Figure 4.15 U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2010 104
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 126
Figure 5.2: Segmentation of the Biomarker Development Market 146
Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2006 156
Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 174
Figure 8.1: Discovery, Validation and Use of Genetic Biomarkers 179
Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 24
Table 2.3: Targeted Drug Therapies for Cancers 24
Table 2.4: Use of Cancer Biomarkers in Drug Development 27
Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development 27
Table 2.6: Time Line for Development of Companion Diagnostics 28
Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2008-2016 29
Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2016 29
Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2010 30
Table 3.4: Key Players and Market Share in Global Molecular Diagnostics Cancer Testing Market 31
Table 3.5: Business Factors Influencing Advanced Oncology Testing Services 32
Table 3.6: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 33
Table 3.7: In Vitro Cancer BioMarker Market Segments Worldwide, 2007 and 2010 34
Table 3.8: Tumor Markers Currently in Common Use 36
Table 3.9: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates 37
Table 3.10: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market,
2001-2010 37
Table 3.11: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 38
Table 3.12: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 38
Table 3.13: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 39
Table 3.14: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 39
Table 3.15: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 39
Table 3.16: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing 40
Table 3.17: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market 40
Table 3.18: Major Presence in Cancer Tumor Marker Diagnostics Markets 40
Table 3.19: Highlights of the Cancer Diagnostic Testing Segment 41
Table 3.20: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services 41
Table 3.21: Strategies for Marketing Cancer Diagnostic Products 45
Table 3.22: Key Elements of MD Diagnostic Companies Marketing Plan 45
Table 4.1: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Gender 48
Table 4.2: Emerging Molecular Diagnostic Technologies 52
Table 4.3: Key Elements for Business Competition in Gene Expression Profiling for Cancer 54
Table 4.4: Key Elements for Future Success in the Gene Profiling for Cancer Segment 54
Table 4.5: Companies Marketing Products in the Cancer Molecular Diagnostics Sector 55
Table 4.6: Breast Cancer Overview 56
Table 4.7: Overview of ER/PR Testing and Response to Therapy 56
Table 4.8: Key Players in the Breast Cancer Molecular Diagnostic Space 57
Table 4.9: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay 58
Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX 60
Table 4.11: Overview of HER2/neu and Herceptin 62
Table 4.12: MammaPrint: Key Features 67
Table 4.13: Oncogene Science Biomarker Group Reagents 68
Table 4.14: Major Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2010 70
Table 4.15: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2010 70
Table 4.16: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2010 71
Table 4.17: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2011-2016 72
Table 4.18: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2011-2016 72
Table 4.19: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in
Order of Impact 73
Table 4.20: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in
Order of Impact 73
Table 4.21: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market 74
Table 4.22: Colorectal Cancer Overview 76
Table 4.23: KRAS Mutation Assay 77
Table 4.24: KRAS Assays by Analytical Type 78
Table 4.25: KRAS Mutation Analysis Summary 79
Table 4.26: DxS KRAS Mutation Test Summary 79
Table 4.27: KRAS and BRAF in Clinical Use 81
Table 4.28: Product Development Opportunities in Cancer Tumor Types, 2008 81
Table 4.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space 82
Table 4.30: ArcticDx Genetic Test, Colo Risk 85
Table 4.31: NexCourse CRC Test Offering and Treatment Direction 87
Table 4.32: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2010 89
Table 4.33: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2010 89
Table 4.34: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2011-2016 90
Table 4.35: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2016 90
Table 4.36: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in
Order of Impact 91
Table 4.37: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in
Order of Impact 91
Table 4.38: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 93
Table 4.39: Players in the Prostate Cancer Molecular Diagnostic Space 95
Table 4.40: Players in the Bladder Cancer Molecular Diagnostic Space 100
Table 4.41: Commercially Available Molecular Diagnostic Products for Ovarian Caner Assay 103
Table 4.42: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2010 104
Table 4.43: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2010 104
Table 4.44: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2011-2016 105
Table 4.45: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2010-2016 105
Table 4.46: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 106
Table 4.47: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 106
Table 4.48: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market 107
Table 4.49: Lung Cancer Survival Rates 107
Table 4.50: Lung Cancer Facts 108
Table 4.51: Potential of Cancer Biomarkers in Drug Delivery and Development 117
Table 4.52: Barriers to Adoption of Biomarkers in Clinical Use 117
Table 5.1: Technology Trends in Cancer Testing 120
Table 5.2: Trends in Theranostics 121
Table 5.3: Market Trends in Cancer Testing 122
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 122
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 122
Table 5.6: Companies That Offer Products to Profile Gene Expression in Breast Cancer 128
Table 5.7: Principal Competitive Factors in the Cancer Screening Market 128
Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of
Care Market 129
Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 130
Table 5.10: Total Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges (U.S.) 130
Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development 147
Table 6.1: CPT Codes for Tumor Markers 154
Table 6.2: Genomic Health Oncotype DX Sales, 2006-2010 157
Table 6.3: Drivers in KRAS Testing 159
Table 6.4: Factors Determining Third-Party Payment for Advanced Cancer Tests 161
Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business 166
Table 7.2: Focus Areas for the FDA Critical Path Initiative 173
Table A1: Tumor Markers Currently in Common Use 200
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