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Molecular Diagnostics in Cancer Testing

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Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

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
 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
 
 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
 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
 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
 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
 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
 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
 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
 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
 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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Reports Details

Published Date : Jun 2016
No. of Pages :201
Country :Global
Category :Healthcare
Publisher :TriMark Publications, LLC
Report Delivery By :Email
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