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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 report describes the specific segment of the in vitro diagnostics market known as molecular diagnostics, with a specialization in the molecular diagnostic tests for cancer.

In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer.

This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

Table of Contents

• 1. Overview 6
  • 1.1Statement of Report6
  • 1.2 About This Report 6
  • 1.3 Scope of the Report 7
  • 1.4Objectives7
  • 1.5 Methodology8
  • 1.6 Executive Summary9
  
  
• 2. Introduction to Molecular Diagnostics13
  • 2.1Opening Up of Opportunities in Molecular Diagnostics13
  • 2.2 Impact of the Human Genome Project on Molecular Diagnostics15
  • 2.3 Considerations for Molecular and Clinical Diagnostics16
  • 2.4 Molecular Diagnostics in the Post-Genomic Era19
  • 2.5 Advances in Molecular Diagnostics Technologies 20
  • 2.6Oligonucleotide Array Platforms21
  • 2.7Emerging Cancer Personalized Medicine Market 22
  • 2.8Companion Tests for Drug Development24
  
  
• 3.Cancer Diagnostics Molecular Testing Market27
  • 3.1Market Description 30
    • 3.1.1Market Overview 30
    • 3.1.2Tumor Markers31
    • 3.1.3Molecular Diagnostic Markers39
    • 3.1.4Competitive Landscape40
    • 3.1.5Sales and Marketing Strategies for Cancer Tests42
      • 3.1.5.1North American Market44
      • 3.1.5.2International Markets45
      • 3.1.5.3Europe45
      • 3.1.5.4Asia/Pacific46
      
      
• 4.Molecular Diagnostic Tests for Cancer 47
  • 4.1Cancer Diagnostic Tests47
    • 4.1.1Use of Genomics to Understand Cancer 48
    • 4.1.2Molecular Diagnostic Tools Solutions50
    • 4.1.3Technology of Gene Expression Analysis51
      • 4.1.3.1Amplify and Detect Diminished Amounts of RNA Consistently51
      • 4.1.3.2Analyze Hundreds of Genes 52
      • 4.1.3.3Employ Advanced Information Technology52
  • 4.2Breast Cancer53
    • 4.2.1Cancer Prognostic Assays54
      • 4.2.1.1Oncotype DX56
    • 4.2.2Single Gene Reporting (ER, PR, HER2)57
      • 4.2.2.1Node Positive (N+) 57
      • 4.2.2.2Aromatase Inhibitors57
    • 4.2.3Product Development58
      • 4.2.3.1Product Development Opportunities in Breast Cancer 58
    • 4.2.4InterGenetics, Incorporated 58
    • 4.2.5HER-259
    • 4.2.6BioTheronostics (AviaraDx)62
    • 4.2.7Agendia B.V.63
    • 4.2.8Exagen 65
    • 4.2.9Applied Genomics65
  • 4.3Colorectal Cancer Molecular Diagnostics Market 66
    • 4.3.1Players in the Colorectal Cancer Space 68
      • 4.3.1.1Background on KRAS Mutation74
      • 4.3.1.2BRAF Mutation Analysis 77
  • 4.4Prostate Cancer Molecular Diagnostics Market78
  • 4.5Other Cancer Molecular Diagnostic Markets 83
    • 4.5.1Bladder Cancer 83
    • 4.5.2Ovarian Cancer 84
    • 4.5.3Lung Cancer 84
    • 4.5.4Melanoma88
  • 4.6Molecular Diagnostic Screening Test for Cancer89
    • 4.6.1Extreme Drug Resistance assay (Oncotech EDR Assay)90
    • 4.6.2Multidrug Resistance Protein (MRP)90
  • 4.7Companion Diagnostic Tests for Cancer Therapeutics 91
  
  
• 5.Business 93
  • 5.1Technology and Market Trends93
    • 5.1.1Technology Trends93
    • 5.1.2Market Trends93
  • 5.2M&A Activity95
  • 5.3Partnerships97
  • 5.4Competitive Analysis98
    • 5.4.1Primary Competitors98
    • 5.4.2Industry Challenges and Strategic Recommendations 100
    • 5.4.3Commercialization of Molecular Diagnostic Products 100
  • 5.5SWOT Comparison of Business Models for Cancer Diagnostic Testing 102
  • 5.6Intellectual Property Rights118
  
  
• 6.Reimbursement and Billing119
  • 6.1Overview 119
  • 6.2Trends in Reimbursement Practice119
    • 6.2.1Medicare Reimbursement 119
    • 6.2.2Analysis of ROI for Molecular Diagnostic Tests for Cancer Using Medicare Reimbursement Rules 123
    • 6.2.3Reimbursement for Insight Dx, MammaPrint and Oncotype Dx123
  • 6.3Breast Cancer Tests 124
  • 6.4Colon Cancer Tests 125
  • 6.5Trends in Patient Care and Reimbursement127
  • 6.6Revenue Threats 128
    • 6.6.1Medicare Exceptions130
    • 6.6.2Three Areas for Denial of Claims by Biomarkers130
  • 6.7Billing 131
    • 6.7.1Medicare Billing Procedures 131
    • 6.7.2Medicare CPT Coding Rules for Cancer Biomarkers132
    
    
• 7.Government Regulation133
  • 7.1U.S. Food and Drug Administration 133
  • 7.2CLIA Regulations134
  • 7.3Clinical Laboratory Improvement Act (CLIA)135
  • 7.4State Licensing for Service Laboratories137
  • 7.5IVDMIAs137
  • 7.6510(k) Clearance 138
  • 7.7Pre-Market Approval (PMA) 138
  • 7.8ASRs138
  • 7.9What Regulatory Guidance Is Needed for Companion Biomarkers?138
  • 7.10U.S. Patent and Trademark Office (USPTO) 139
  • 7.11IRB Approval in Clinical Trials140
  • 7.12Oncology Biomarkers Qualification Initiative Project140
  • 7.13FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX 140
  • 7.14FDA Packaging Requirements for Erbitux141
  
  
• 8.Business Decisions Using Molecular Diagnostic Tests in Drug Development142
  • 8.1Advantages of a Pharmacogenomic Assessment of Genetic Biomarkers to Determine Clinical Dose 142
  • 8.2What are Key Opportunities in Biomarker Discovery, Development and Commercialization142
  • 8.3What Are the Current Obstacles in Biomarker Implementation?142
  • 8.4How Do Business Strategies, Such as Those Relating to Acquisition, Drive Biomarker Strategies?143
  • 8.5What is the Right Balance between Using External Partnerships and Developing Internal Infrastructure?143
  • 8.6How Might Novel Biomarker Development Lead to Acquisition Strategies?143
  • 8.7Which Types of Genetic Biomarkers Should Be Developed by Diagnostic Companies?143
  • 8.8What Strategies Help Translate Genetic biomarkers From Preclinical to Clinical Development?143
  • 8.9In What Class of Drugs Is the Value of Using Genetic biomarkers in Decision Making the Highest? 144
  • 8.10How Can Regulatory Oversight Drive Approval and Adoption of New Technologies?145
  • 8.11How Can Big Pharma Co-develop Genetic biomarkers in a Cost-sharing Model for Regulatory Acceptance?145
  • 8.12How Are Genetic Biomarkers Being Used to Reduce the Attrition Rate in Drug Development?145
  • 8.13How Is ROI Measured Using Genetic Biomarkers in Drug Development?145
  • 8.14How Might Organizational Structures Limit the Use of Genetic Biomarkers in Drug Development and How Should R&D Organizations Address This Problem?145
  • 8.15How to Maximize Business Development through Biomarker Strategies146
  • 8.16What Is the Best Type of Business Model for Developing Genetic Biomarkers? 146
  • 8.17What Are Organizational Impediments in Genetic Biomarkers in Drug Development?146
  • 8.18What Are Internal Capabilities for Novel Biomarker Development and Application?146
  • 8.19How Can Key Biomarker Technical Expertise Be Applied Across a Complex and Highly-Stratified R&D Value Chain?147
  • 8.20At What Stage of Drug Development Have Genetic Biomarkers Provided the Most Benefit147
  • 8.21What Companies Are the Most Innovative in Development of Genetic Biomarkers?147
  • 8.22Best Values for Genetic biomarkers in Drug Development and in Diagnostics147
  • 8.23Molecular Diagnostic Tests Can Increase Value in an Associated Drug147
  
  
• 9.Company Profiles149
  • 9.1Agendia 149
  • 9.2ArcticDx Inc.149
  • 9.3Arcxis Biotechnologies149
  • 9.4Aureon Laboratories150
  • 9.5bioTheranostics (AviaraDx)150
  • 9.6Clarient, Inc.151
  • 9.7CombiMatrix Corporation151
  • 9.8DiagnoCure152
  • 9.9DxS152
  • 9.10Exagen Diagnostics, Inc.152
  • 9.11Exiqon 152
  • 9.12Ferrer in Code153
  • 9.13Genomic Health Inc.153
  • 9.14Genoptix, Inc.154
  • 9.15Gen-Probe154
  • 9.16InterGenetics, Incorporated155
  • 9.17LabCorp 155
  • 9.18Myriad Genetics 156
  • 9.19Nuerva Biosciences 156
  • 9.20Orion Genomics 157
  • 9.21QIAGEN157
  • 9.22Rosetta Genomics158
  • 9.23Sequenom158
  • 9.24SABiosciences Corporation158
  • 9.25Source MDx158
  • 9.26Targeted Molecular Diagnostics159
  • 9.27Xenomics, Inc.159
  
  

Appendix 1:Definition of Terms for Molecular Diagnostics161

Appendix 2:Standard Cancer Therapeutic Panels163

Appendix 3:Menu of Specialized Technologies Used To Assess and Characterize Cancer166

Appendix 4:Technical Assessment of the KRAS Mutation Test by Several Methodologies and Specialty Oncology Laboratories168

Appendix 5:Overview of Microarrays170

INDEX OF FIGURES

Figure 2.1:Finding Genes with Microassays14

Figure 2.2:Use of Microassays for Studying Gene Expression15

Figure 2.3:Using DNA Microarrays to Compare Cancer and Normal Cells16

Figure 2.4:Microarrays for Prediction of Survival in Cancer 18

Figure 2.5:Finding New Drugs with Microarrays23

Figure 2.6:Using Gene Expression Patterns to Chose Treatment24

Figure 2.7:Segmentation of the Biomarker Development Market 25

Figure 3.1:Applications of Key Players and Market Share in Molecular Diagnostics Testing Markets 29

Figure 3.2:Market Growth and Evolution of MD Cancer Biomarkers43

Figure 4.1:Using DNA Microassays to Measure Gene Expression49

Figure 4.2:Schematic of Molecular Diagnostics for Studying Gene Expression in Patients49

Figure 4.3:HER-2/NEU Protein as a Target in Cancer Therapy59

Figure 4.4:ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 60

Figure 4.5:ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH61

Figure 4.6:Action of Herceptin in Breast Cancer Patients61

Figure 4.7:Analysis of Cancer Tissue by Microarray64

Figure 4.8:Incidence of CRC by Age Group67

Figure 4.9:HNPCC Mutation Increases Risk of Cancer72

Figure 4.10:APC Mutation Increases the Risk of Cancer73

Figure 4.11:KRAS Mutation Assay from Exiqon Diagnostics 73

Figure 4.12:KRAS Assays by Analytical Type75

Figure 4.13:DxS KRAS Mutation Test Summary77

Figure 4.14:Prostate Specific Membrane Antigen79

Figure 4.15:Estimates for PCA3 Test Volume in U.S., 2005-2008 81

Figure 5.1:FDA Co-Developed Products as a Model for Collaboration 98

Figure 5.2:Segmentation of the Biomarker Development Market 116

Figure 6.1:Number of Oncotype DX Tests Performed, 2006-2009124

Figure 7.1:OBQI and the Relationship of Governmental Regulatory Agencies140

Figure 8.1:Discovery, Validation and Use of Genetic Biomarkers144

INDEX OF TABLES

Table 2.1:Genes and Cancer Risk18

Table 2.2:Use of Cancer Biomarkers to Enhance Patient Care22

Table 2.3:Targeted Drug Therapies for Cancers23

Table 2.4:Use of Cancer Biomarkers in Drug Development26

Table 2.5:Utility of Biomarkers as Companion Diagnostics to Drug Development 26

Table 2.6:Time Line for Development of Companion Diagnostics26

Table 3.1:Global Market for Molecular Diagnostics Cancer Testing, 2008-201227

Table 3.2:Global Market for Molecular Diagnostics Testing, 2008-2012 27

Table 3.3:U.S. Market for Molecular Diagnostics Testing, 2004-2012 28

Table 3.4:Key Players and Market Share in Molecular Diagnostics Testing Market28

Table 3.5:Business Factors Influencing Advanced Oncology Testing Services29

Table 3.6:Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market31

Table 3.7:In Vitro Cancer Marker Market Segments Worldwide, 2001 and 2007 31

Table 3.8:Tumor Markers Currently in Common Use34

Table 3.9:Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates35

Table 3.10:Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-201035

Table 3.11:U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010 36

Table 3.12:Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 36

Table 3.13:U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201037

Table 3.14:Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201037

Table 3.15:European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010 37

Table 3.16:Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing 38

Table 3.17:Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market38

Table 3.18:Major Presence in Cancer Tumor Marker Diagnostics Markets 38

Table 3.19:Leading Segments of the Molecular Diagnostic Testing Market39

Table 3.20:Highlights of the Cancer Diagnostic Testing Segment 39

Table 3.21:Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services 39

Table 3.22:Strategies for Marketing Cancer Diagnostic Products 44

Table 3.23:Key Elements of MD Diagnostic Companies Marketing Plan44

Table 4.1:Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Gender47

Table 4.2:Key Elements for Business Competition in Gene Expression Profiling for Cancer52

Table 4.3:Key Elements for Future Success in the Gene Profiling for Cancer Segment52

Table 4.4:Breast Cancer Overview53

Table 4.5:Overview of ER/PR Testing and Response to Therapy54

Table 4.6:Players in the Breast Cancer Molecular Diagnostic Space55

Table 4.7:Clinical Utility and Health Economic Benefits of Oncotype DX57

Table 4.8:Overview of HER2/neu and Herceptin 60

Table 4.9:MammaPrint: Key Features64

Table 4.10:Siemens Oncogene Science Biomarker Group Reagents65

Table 4.11:Colorectal Cancer Overview66

Table 4.12:TNM Staging System for Colorectal Cancer68

Table 4.13:Players in the Colorectal Cancer Molecular Diagnostic Space68

Table 4.14:ArcticDx Genetic Test, Colo Risk72

Table 4.15:Product Development Opportunities in Cancer Tumor Types78

Table 4.16:Players in the Prostate Cancer Molecular Diagnostic Space 79

Table 4.17:Players in the Bladder Cancer Molecular Diagnostic Space 83

Table 4.18:Lung Cancer Survival Rates85

Table 4.19:Lung Cancer Facts 86

Table 4.20:Potential of Cancer Biomarkers in Drug Delivery and Development92

Table 4.21:Barriers to Adoption of Biomarkers in Clinical Use92

Table 5.1:Technology Trends in Cancer Testing93

Table 5.2:Trends in Theranostics93

Table 5.3:Market Trends in Cancer Testing94

Table 5.4:Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact94

Table 5.5:Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact95

Table 5.6:Companies That Offer Products to Profile Gene Expression in Breast Cancer99

Table 5.7:Principal Competitive Factors in the Cancer Screening Market 99

Table 5.8:Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions 100

Table 5.9:Total Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges (U.S.)100

Table 5.10:Utility of Biomarkers as Companion Diagnostics to Drug Development 117

Table 6.1:CPT Codes for Tumor Markers122

Table 6.2:Genomic Health Oncotype DX Sales124

Table 6.3:Drivers in KRAS Testing127

Table 6.4:Factors Determining Third Party Payment for Advanced Cancer Tests129

Table 7.1:Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business133

Table 7.2:Focus Areas for the FDA Critical Path Initiative139

Table A1:Tumor Markers Currently in Common Use165

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