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.
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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 11
1.6 Executive Summary 12

2. Introduction to Molecular Diagnostics 16
2.1 Opening-up 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 Tumor Markers 35
3.1.3 Molecular Diagnostic Markers 41
3.1.4 Competitive Landscape 42
3.1.5 Sales and Marketing Strategies for Cancer Tests 45
3.1.5.1 North American Market 46
3.1.5.2 International Markets 47
3.1.5.3 Europe 47
3.1.5.4 Asia-Pacific 48

4. Molecular Diagnostic Tests for Cancer 49
4.1 Cancer Diagnostic Tests 49
4.1.1 Use of Genomics to Understand Cancer 50
4.1.2 Molecular Diagnostic Tools Solutions 52
4.1.3 Technology of Gene Expression Analysis 54
4.1.3.1 Amplify and Detect Diminished Amounts of RNA Consistently 54
4.1.3.2 Analyze Hundreds of Genes 55
4.1.3.3 Employ Advanced Information Technology 55
4.2 Breast Cancer 56
4.2.1 Cancer Prognostic Assays 58
4.2.1.1 Myriad Genetics (BRACA1 and BRACA2) 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 (N+) 61
4.2.1.2.3 Aromatase Inhibitors 61
4.2.1.2.4 Product Development 61
4.2.1.2.5 Product Development Opportunities in Breast Cancer 62
4.2.1.3 InterGenetics, Inc. 62
4.2.1.4 LabCorp (HER-2) 63
4.2.1.5 Clarient, Inc. 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
4.2.2 Competition and Comparison of Methods 70
4.2.3 Competitive Structure and Market Share Analysis 70
4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 71
4.2.3.1.1 Global Market 71
4.2.3.1.2 U.S. Market 72
4.2.3.1.3 European Market 72
4.2.3.2 Market Forecasts 73
4.2.3.2.1 Revenue Forecasts 73
4.2.3.3 Market Drivers and Restraints 74
4.2.3.3.1 Market Drivers 74
4.2.3.3.2 Market Restraints 74
4.2.3.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 74
4.2.3.4.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 74
4.2.3.4.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 75
4.2.3.4.3 Breast Cancer Testing Assay Strategic Recommendations 75
4.3 Colorectal Cancer Molecular Diagnostics Market 76
4.3.1 Colon Cancer Testing Platforms 77
4.3.1.1 Genomic Testing 77
4.3.1.1.1 IVD Multiplex Index Analysis (MIA) 77
4.3.1.1.2 The BRAF Test 78
4.3.1.1.3 KRAS 78
4.3.1.1.3.1 Background on KRAS Mutation 78
4.3.1.1.4 mSEPT9 82
4.3.1.2 Screening Test 82
4.3.2 Players in the Colorectal Cancer Space 83
4.3.3 Competitive Structure and Market Share Analysis 89
4.3.3.1 Colon Cancer Molecular Diagnostic Testing Market Size 90
4.3.3.1.1 Global Colon Cancer testing Market 90
4.3.3.1.2 U.S. Colon Cancer testing Market 90
4.3.3.1.3 European Colon Cancer testing Market 91
4.3.3.2 Market Forecasts 91
4.3.3.2.1 Revenue Forecasts 91
4.3.3.3 Market Drivers and Restraints 92
4.3.3.3.1 Market Drivers 92
4.3.3.3.2 Market Restraints 92
4.3.3.4 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 92
4.3.3.4.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 92
4.3.3.4.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 93
4.3.3.4.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 93
4.4 Prostate Cancer Molecular Diagnostics Market 95
4.5 Other Cancer Molecular Diagnostic Markets 102
4.5.1 Bladder Cancer 102
4.5.2 Ovarian Cancer 103
4.5.2.1 Incidence of Ovarian Cancer 103
4.5.2.2 Key Players in Ovarian Testing market 104
4.5.2.3 Ovarian Cancer Market Size 105
4.5.2.4 Ovarian Cancer Molecular Diagnostic Testing Market Size 106
4.5.2.4.1 Global Ovarian Cancer testing Market 106
4.5.2.4.2 U.S. Ovarian Cancer testing Market 106
4.5.2.4.3 European Ovarian Cancer testing Market 107
4.5.2.5 Market Forecasts 107
4.5.2.5.1 Revenue Forecasts 108
4.5.2.6 Market Drivers and Restraints 108
4.5.2.6.1 Market Drivers 108
4.5.2.6.2 Market Restraints 109
4.5.2.7 Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 109
4.5.2.7.1 Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends 109
4.5.2.7.2 Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends 109
4.5.2.7.3 Ovarian Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 109
4.5.3 Lung Cancer 110
4.5.4 Melanoma 116
4.6 Molecular Diagnostic Screening Test for Cancer 117
4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay) 118
4.6.2 Multidrug Resistance Protein (MRP) 118
4.7 Companion Diagnostic Tests for Cancer Therapeutics 119

5. Business 123
5.1 Technology and Market Trends 123
5.1.1 Technology Trends 124
5.1.2 Market Trends 125
5.2 M&A Activity 127
5.3 Partnerships 130
5.4 Competitive Analysis 133
5.4.1 Primary Competitors 133
5.4.1.1 Summary of Market Strengths, Weaknesses, Opportunities and Threats 134
5.4.2 Industry Challenges and Strategic Recommendations 135
5.4.3 Commercialization of Molecular Diagnostic Products 135
5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 137
5.6 Intellectual Property Rights 153
5.6.1 BRCA1 and BRCA2 Gene Patents 154
5.6.2 Current Patent Disputes 155

6. Reimbursement and Billing 156
6.1 Overview 156
6.2 Trends in Reimbursement Practice 156
6.2.1 Medicare Reimbursement 157
6.2.2 Analysis of ROI for MD Tests for Cancer Using Medicare Reimbursement Rules 160
6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 161
6.2.4 Reimbursement for JAK2 Mutation Testing for Myeloproliferative Neoplasms 161
6.3 Breast Cancer Tests 161
6.4 Colon Cancer Tests 163
6.5 Trends in Patient Care and Reimbursement 165
6.6 Revenue Threats 167
6.6.1 Medicare Exceptions 168
6.6.2 Three Areas for Denial of Claims by Biomarkers 168
6.7 Billing 169
6.7.1 Medicare Billing Procedures 169
6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers 170

7. Government Regulation 171
7.1 U.S. Food and Drug Administration 171
7.2 CLIA Regulations 172
7.3 Clinical Laboratory Improvement Act (CLIA) 173
7.4 State Licensing for Service Laboratories 174
7.5 FDA Treatment of Multivariate Index Assays (IVDMIAs) 175
7.6 510(k) Clearance 176
7.7 Pre-Market Approval (PMA) 176
7.8 ASRs 177
7.9 What Regulatory Guidance is Needed for Companion Biomarkers? 177
7.10 U.S. Patent and Trademark Office (USPTO) 178
7.11 IRB Approval in Clinical Trials 178
7.12 Oncology Biomarkers Qualification Initiative Project 178
7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX 179
7.14 FDA Packaging Requirements for Erbitux 179
7.15 Micoarray Quality Control (MAQC) 179
7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing 180
7.17 ER and PR Proficiency Testing 181

8. Business Decisions Using Molecular Diagnostic Tests in Drug Development 182
8.1 Advantages of a Pharmacogenomic Assessment of Genetic Biomarkers to Determine
Clinical Dose 182
8.2 What are Key Opportunities in Biomarker Discovery, Development and Commercialization? 182
8.3 What are the Current Obstacles in Biomarker Implementation? 182
8.4 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies? 183
8.5 What is the Right Balance between External Partnerships and Internal Infrastructure? 183
8.6 How might Novel Biomarker Development Lead to Acquisition Strategies? 183
8.7 Which Types of Genetic Biomarkers should be Developed by Diagnostic Companies? 183
8.8 What Strategies Help Translate Genetic biomarkers from Preclinical to Clinical Development? 183
8.9 In what Class of Drugs is the Value of Using Genetic biomarkers in Decision making the Highest? 184
8.10 How can Regulatory Oversight Drive Approval and Adoption of New Technologies? 185
8.11 How can Big Pharma Co-develop Genetic Biomarkers for Regulatory Acceptance? 185
8.12 How are Genetic Biomarkers being Used to reduce the Attrition Rate in Drug Development? 185
8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development? 185
8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and how should R&D Organizations Address this Problem? 185
8.15 How to Maximize Business Development through Biomarker Strategies? 186
8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers? 186
8.17 What are Organizational Impediments in Genetic Biomarkers in Drug Development? 186
8.18 What are Internal Capabilities for Novel Biomarker Development and Application? 186
8.19 How can Key Biomarker Technical Expertise be Applied across a Complex and Highly-Stratified R&D Value Chain? 187
8.20 At what Stage of Drug Development has Genetic Biomarkers Provided the Most Benefit? 187
8.21 What Companies are the most Innovative in Development of Genetic Biomarkers? 187
8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics 187
8.23 Molecular Diagnostic Tests can Increase Value in an Associated Drug 188

9. Company Profiles 189
9.1 Agendia 189
9.2 ArcticDx, Inc. 189
9.3 Arcxis Biotechnologies 189
9.4 Aureon Laboratories 190
9.5 Biodesix 190
9.6 bioTheranostics (AviaraDx) 191
9.7 Clarient, Inc. 191
9.8 CombiMatrix Corporation 191
9.9 Epigenomics 192
9.10 Exact Sciences Corporation 192
9.11 Exagen Diagnostics, Inc. 192
9.12 Exiqon 193
9.13 Ferrer inCode 193
9.14 Genomic Health, Inc. 193
9.15 Genoptix, Inc. 194
9.16 Gen-Probe 194
9.17 InterGenetics, Inc. 195
9.18 LabCorp 196
9.19 Myriad Genetics, Inc. 196
9.20 Nuvera Biosciences 197
9.21 Orion Genomics 197
9.22 QIAGEN NV 197
9.23 Rosetta Genomics Ltd. 198
9.24 Seegene 199
9.25 Sequenom, Inc. 199
9.26 SABiosciences Corporation 199
9.27 Source MDx 199
9.28 Targeted Molecular Diagnostics 200
9.29 Xenomics, Inc. 200

Appendix 1: Definition of Terms for Molecular Diagnostics 201
Appendix 2: Standard Cancer Therapeutic Panels 203
Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize Cancer 206
Appendix 4: Technical Assessment of the KRAS Mutation Test by Several Methodologies and Specialty Oncology Laboratories 208
Appendix 5: Overview of Microarrays 210
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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, 2010 31
Figure 3.2: Molecular Diagnostic Markets for Cancer Testing U.S., 2010 31
Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Cancer Testing Markets 32
Figure 3.4: Market Growth and Evolution of MD Cancer Biomarkers 45
Figure 4.1: Using DNA Microassays to Measure Gene Expression 51
Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients 51
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 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, 2010 72
Figure 4.9: Incidence of CRC by Age Group 77
Figure 4.10: HNPCC Mutation Increases Risk of Cancer 87
Figure 4.11: APC Mutation Increases the Risk of Cancer 88
Figure 4.12: U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2010 90
Figure 4.13: Prostate-Specific Membrane Antigen 96
Figure 4.14: PCA3 Score Nomogram 98
Figure 4.15: Estimates for PCA3 Test Volume in U.S., 2005-2008 99
Figure 4.16: U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market, 2010 107
Figure 5.1: FDA Co-developed Products as a Model for Collaboration 131
Figure 5.2: Segmentation of the Biomarker Development Market 151
Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2011 161
Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 179
Figure 8.1: Discovery, Validation and Use of Genetic Biomarkers 184

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, 2008-2016 30
Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2016 30
Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2010 31
Table 3.4: Key Players and Market Share in Global Molecular Diagnostics Cancer Testing Market 32
Table 3.5: Business Factors Influencing Advanced Oncology Testing Services 33
Table 3.6: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market 34
Table 3.7: In Vitro Cancer BioMarker Market Segments Worldwide, 2007 and 2010 35
Table 3.8: Tumor Markers Currently in Common Use 37
Table 3.9: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates 38
Table 3.10: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 38
Table 3.11: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 39
Table 3.12: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 39
Table 3.13: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 40
Table 3.14: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 40
Table 3.15: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 40
Table 3.16: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing 41
Table 3.17: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market 41
Table 3.18: Major Presence in Cancer Tumor Marker Diagnostics Markets 41
Table 3.19: Highlights of the Cancer Diagnostic Testing Segment 42
Table 3.20: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services 42
Table 3.21: Strategies for Marketing Cancer Diagnostic Products 46
Table 3.22: Key Elements of MD Diagnostic Companies Marketing Plan 46
Table 4.1: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Gender 49
Table 4.2: Emerging Molecular Diagnostic Technologies 53
Table 4.3: Key Elements for Business Competition in Gene Expression Profiling for Cancer 55
Table 4.4: Key Elements for Future Success in the Gene Profiling for Cancer Segment 55
Table 4.5: Companies Marketing Products in the Cancer Molecular Diagnostics Sector 56
Table 4.6: Breast Cancer Overview 57
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 Products for Breast Cancer Assay 59
Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX 61
Table 4.11: Overview of HER2/neu and Herceptin 63
Table 4.12: MammaPrint: Key Features 68
Table 4.13: Oncogene Science Biomarker Group Reagents 69
Table 4.14: Major Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2010 71
Table 4.15: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2010 71
Table 4.16: U.S. Market for Breast Cancer Molecular Diagnostic Testing, 2005-2010 72
Table 4.17: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2011-2016 73
Table 4.18: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2011-2016 73
Table 4.19: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 74
Table 4.20: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 74
Table 4.21: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market 75
Table 4.22: Colorectal Cancer Overview 77
Table 4.23: KRAS Mutation Assay 78
Table 4.24: KRAS Assays by Analytical Type 79
Table 4.25: KRAS Mutation Analysis Summary 80
Table 4.26: DxS KRAS Mutation Test Summary 80
Table 4.27: KRAS and BRAF in Clinical Use 82
Table 4.28: Product Development Opportunities in Cancer Tumor Types, 2008 82
Table 4.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space 83
Table 4.30: ArcticDx Genetic Test, Colo Risk 86
Table 4.31: NexCourse CRC Test Offering and Treatment Direction 88
Table 4.32: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2010 90
Table 4.33: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2010 90
Table 4.34: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2011-2016 91
Table 4.35: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2016 91
Table 4.36: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact 92
Table 4.37: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact 92
Table 4.38: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market 94
Table 4.39: Players in the Prostate Cancer Molecular Diagnostic Space 96
Table 4.40: Gen-Probe Genetic Testing Product Line 100
Table 4.41: Players in the Bladder Cancer Molecular Diagnostic Space 102
Table 4.42: Commercially Available Molecular Diagnostic Products for Ovarian Caner Assay 105
Table 4.43: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2010 106
Table 4.44: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2010 106
Table 4.45: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2011-2016 108
Table 4.46: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2010-2016 108
Table 4.47: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact 108
Table 4.48: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact 109
Table 4.49: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market 110
Table 4.50: Lung Cancer Survival Rates 110
Table 4.51: Lung Cancer Facts 111
Table 4.52: Potential of Cancer Biomarkers in Drug Delivery and Development 120
Table 4.53: Barriers to Adoption of Biomarkers in Clinical Use 120
Table 5.1: Technology Trends in Cancer Testing 124
Table 5.2: Trends in Theranostics 125
Table 5.3: Market Trends in Cancer Testing 126
Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact 126
Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact 127
Table 5.6: Companies That Offer Products to Profile Gene Expression in Breast Cancer 133
Table 5.7: Principal Competitive Factors in the Cancer Screening Market 133
Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 134
Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 135
Table 5.10: Total Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges (U.S.) 135
Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development 152
Table 6.1: CPT Codes for Tumor Markers 159
Table 6.2: Genomic Health Oncotype DX Sales, 2006-2010 162
Table 6.3: Drivers in KRAS Testing 164
Table 6.4: Factors Determining Third-Party Payment for Advanced Cancer Tests 167
Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business 171
Table 7.2: Focus Areas for the FDA Critical Path Initiative 178
Table A1: Tumor Markers Currently in Common Use 205
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