Reportlinker Adds Molecular Diagnostics in Cancer Testing

NEW YORK, Jan. 12 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Molecular Diagnostics in Cancer Testing

http://www.reportlinker.com/p0171427/Molecular-Diagnostics-in-Cancer-Testing.html

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 CONTENTS

1. Overview 6

1.1 Statement of Report 6

1.2 About This Report 6

1.3 Scope of the Report 7

1.4 Objectives 7

1.5 Methodology 8

1.6 Executive Summary 9

2. Introduction to Molecular Diagnostics 13

2.1 Opening Up of Opportunities in Molecular Diagnostics 13

2.2 Impact of the Human Genome Project on Molecular Diagnostics 15

2.3 Considerations for Molecular and Clinical Diagnostics 16

2.4 Molecular Diagnostics in the Post-Genomic Era 19

2.5 Advances in Molecular Diagnostics Technologies 20

2.6 Oligonucleotide Array Platforms 21

2.7 Emerging Cancer Personalized Medicine Market 22

2.8 Companion Tests for Drug Development 24

3. Cancer Diagnostics Molecular Testing Market 27

3.1 Market Description 30

3.1.1 Market Overview 30

3.1.2 Tumor Markers 31

3.1.3 Molecular Diagnostic Markers 39

3.1.4 Competitive Landscape 40

3.1.5 Sales and Marketing Strategies for Cancer Tests 42

3.1.5.1 North American Market 44

3.1.5.2 International Markets 45

3.1.5.3 Europe 45

3.1.5.4 Asia/Pacific 46

4. Molecular Diagnostic Tests for Cancer 47

4.1 Cancer Diagnostic Tests 47

4.1.1 Use of Genomics to Understand Cancer 48

4.1.2 Molecular Diagnostic Tools Solutions 50

4.1.3 Technology of Gene Expression Analysis 51

4.1.3.1 Amplify and Detect Diminished Amounts of RNA Consistently 51

4.1.3.2 Analyze Hundreds of Genes 52

4.1.3.3 Employ Advanced Information Technology 52

4.2 Breast Cancer 53

4.2.1 Cancer Prognostic Assays 54

4.2.1.1 Oncotype DX 56

4.2.2 Single Gene Reporting (ER, PR, HER2) 57

4.2.2.1 Node Positive (N+) 57

4.2.2.2 Aromatase Inhibitors 57

4.2.3 Product Development 58

4.2.3.1 Product Development Opportunities in Breast Cancer 58

4.2.4 InterGenetics, Incorporated 58

4.2.5 HER-2 59

4.2.6 BioTheronostics (AviaraDx) 62

4.2.7 Agendia B.V. 63

4.2.8 Exagen 65

4.2.9 Applied Genomics 65

4.3 Colorectal Cancer Molecular Diagnostics Market 66

4.3.1 Players in the Colorectal Cancer Space 68

4.3.1.1 Background on KRAS Mutation 74

4.3.1.2 BRAF Mutation Analysis 77

4.4 Prostate Cancer Molecular Diagnostics Market 78

4.5 Other Cancer Molecular Diagnostic Markets 83

4.5.1 Bladder Cancer 83

4.5.2 Ovarian Cancer 84

4.5.3 Lung Cancer 84

4.5.4 Melanoma 88

4.6 Molecular Diagnostic Screening Test for Cancer 89

4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay) 90

4.6.2 Multidrug Resistance Protein (MRP) 90

4.7 Companion Diagnostic Tests for Cancer Therapeutics 91

5. Business 93

5.1 Technology and Market Trends 93

5.1.1 Technology Trends 93

5.1.2 Market Trends 93

5.2 M&A Activity 95

5.3 Partnerships 97

5.4 Competitive Analysis 98

5.4.1 Primary Competitors 98

5.4.2 Industry Challenges and Strategic Recommendations 100

5.4.3 Commercialization of Molecular Diagnostic Products 100

5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 102

5.6 Intellectual Property Rights 118

6. Reimbursement and Billing 119

6.1 Overview 119

6.2 Trends in Reimbursement Practice 119

6.2.1 Medicare Reimbursement 119

6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Cancer Using Medicare

Reimbursement Rules 123

6.2.3 Reimbursement for Insight Dx, MammaPrint and Oncotype Dx 123

6.3 Breast Cancer Tests 124

6.4 Colon Cancer Tests 125

6.5 Trends in Patient Care and Reimbursement 127

6.6 Revenue Threats 128

6.6.1 Medicare Exceptions 130

6.6.2 Three Areas for Denial of Claims by Biomarkers 130

6.7 Billing 131

6.7.1 Medicare Billing Procedures 131

6.7.2 Medicare CPT Coding Rules for Cancer Biomarkers 132

7. Government Regulation 133

7.1 U.S. Food and Drug Administration 133

7.2 CLIA Regulations 134

7.3 Clinical Laboratory Improvement Act (CLIA) 135

7.4 State Licensing for Service Laboratories 137

7.5 IVDMIAs 137

7.6 510(k) Clearance 138

7.7 Pre-Market Approval (PMA) 138

7.8 ASRs 138

7.9 What Regulatory Guidance Is Needed for Companion Biomarkers? 138

7.10 U.S. Patent and Trademark Office (USPTO) 139

7.11 IRB Approval in Clinical Trials 140

7.12 Oncology Biomarkers Qualification Initiative Project 140

7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX 140

7.14 FDA Packaging Requirements for Erbitux 141

8. Business Decisions Using Molecular Diagnostic Tests in Drug Development 142

8.1 Advantages of a Pharmacogenomic Assessment of Genetic Biomarkers to

Determine Clinical Dose 142

8.2 What are Key Opportunities in Biomarker Discovery, Development and

Commercialization 142

8.3 What Are the Current Obstacles in Biomarker Implementation? 142

8.4 How Do Business Strategies, Such as Those Relating to Acquisition, Drive

Biomarker Strategies? 143

8.5 What is the Right Balance between Using External Partnerships and Developing

Internal Infrastructure? 143

8.6 How Might Novel Biomarker Development Lead to Acquisition Strategies? 143

8.7 Which Types of Genetic Biomarkers Should Be Developed by Diagnostic

Companies? 143

8.8 What Strategies Help Translate Genetic biomarkers From Preclinical to

Clinical Development? 143

8.9 In What Class of Drugs Is the Value of Using Genetic biomarkers in Decision

Making the Highest? 144

8.10 How Can Regulatory Oversight Drive Approval and Adoption of New

Technologies? 145

8.11 How Can Big Pharma Co-develop Genetic biomarkers in a Cost-sharing Model

for Regulatory Acceptance? 145

8.12 How Are Genetic Biomarkers Being Used to Reduce the Attrition Rate in Drug

Development? 145

8.13 How Is ROI Measured Using Genetic Biomarkers in Drug Development? 145

8.14 How Might Organizational Structures Limit the Use of Genetic Biomarkers in

Drug Development and How Should R&D Organizations Address This Problem? 145

8.15 How to Maximize Business Development through Biomarker Strategies 146

8.16 What Is the Best Type of Business Model for Developing Genetic Biomarkers?

146

8.17 What Are Organizational Impediments in Genetic Biomarkers in Drug

Development? 146

8.18 What Are Internal Capabilities for Novel Biomarker Development and

Application? 146

8.19 How Can Key Biomarker Technical Expertise Be Applied Across a Complex and

Highly-Stratified R&D Value Chain? 147

8.20 At What Stage of Drug Development Have Genetic Biomarkers Provided the Most

Benefit 147

8.21 What Companies Are the Most Innovative in Development of Genetic

Biomarkers? 147

8.22 Best Values for Genetic biomarkers in Drug Development and in Diagnostics

147

8.23 Molecular Diagnostic Tests Can Increase Value in an Associated Drug 147

9. Company Profiles 149

9.1 Agendia 149

9.2 ArcticDx Inc. 149

9.3 Arcxis Biotechnologies 149

9.4 Aureon Laboratories 150

9.5 bioTheranostics (AviaraDx) 150

9.6 Clarient, Inc. 151

9.7 CombiMatrix Corporation 151

9.8 DiagnoCure 152

9.9 DxS 152

9.10 Exagen Diagnostics, Inc. 152

9.11 Exiqon 152

9.12 Ferrer in Code 153

9.13 Genomic Health Inc. 153

9.14 Genoptix, Inc. 154

9.15 Gen-Probe 154

9.16 InterGenetics, Incorporated 155

9.17 LabCorp 155

9.18 Myriad Genetics 156

9.19 Nuerva Biosciences 156

9.20 Orion Genomics 157

9.21 QIAGEN 157

9.22 Rosetta Genomics 158

9.23 Sequenom 158

9.24 SABiosciences Corporation 158

9.25 Source MDx 158

9.26 Targeted Molecular Diagnostics 159

9.27 Xenomics, Inc. 159

Appendix 1: Definition of Terms for Molecular Diagnostics 161

Appendix 2: Standard Cancer Therapeutic Panels 163

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

Cancer 166

Appendix 4: Technical Assessment of the KRAS Mutation Test by Several

Methodologies and Specialty Oncology Laboratories 168

Appendix 5: Overview of Microarrays 170

INDEX OF FIGURES

Figure 2.1: Finding Genes with Microassays 14

Figure 2.2: Use of Microassays for Studying Gene Expression 15

Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells 16

Figure 2.4: Microarrays for Prediction of Survival in Cancer 18

Figure 2.5: Finding New Drugs with Microarrays 23

Figure 2.6: Using Gene Expression Patterns to Chose Treatment 24

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 Biomarkers 43

Figure 4.1: Using DNA Microassays to Measure Gene Expression 49

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

Patients 49

Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy 59

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

FISH 61

Figure 4.6: Action of Herceptin in Breast Cancer Patients 61

Figure 4.7: Analysis of Cancer Tissue by Microarray 64

Figure 4.8: Incidence of CRC by Age Group 67

Figure 4.9: HNPCC Mutation Increases Risk of Cancer 72

Figure 4.10: APC Mutation Increases the Risk of Cancer 73

Figure 4.11: KRAS Mutation Assay from Exiqon Diagnostics 73

Figure 4.12: KRAS Assays by Analytical Type 75

Figure 4.13: DxS KRAS Mutation Test Summary 77

Figure 4.14: Prostate Specific Membrane Antigen 79

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, 2006-2009 124

Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies 140

Figure 8.1: Discovery, Validation and Use of Genetic Biomarkers 144

INDEX OF TABLES

Table 2.1: Genes and Cancer Risk 18

Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care 22

Table 2.3: Targeted Drug Therapies for Cancers 23

Table 2.4: Use of Cancer Biomarkers in Drug Development 26

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

Table 2.6: Time Line for Development of Companion Diagnostics 26

Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2008-2012 27

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 Market

28

Table 3.5: Business Factors Influencing Advanced Oncology Testing Services 29

Table 3.6: Specific Diagnostic Products Categories Comprising the Cancer

Diagnostic Market 31

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

Table 3.8: Tumor Markers Currently in Common Use 34

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

35

Table 3.10: Worldwide Market Size in Dollar Volume for Tumor Marker Assays

Product Market, 2001-2010 35

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, 2001-2010

37

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

2001-2010 37

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 Market 38

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

Table 3.19: Leading Segments of the Molecular Diagnostic Testing Market 39

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 Plan 44

Table 4.1: Estimates for the Leading Sites of New Cancer Cases and Deaths in the

U.S. by Gender 47

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

for Cancer 52

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

Segment 52

Table 4.4: Breast Cancer Overview 53

Table 4.5: Overview of ER/PR Testing and Response to Therapy 54

Table 4.6: Players in the Breast Cancer Molecular Diagnostic Space 55

Table 4.7: Clinical Utility and Health Economic Benefits of Oncotype DX 57

Table 4.8: Overview of HER2/neu and Herceptin 60

Table 4.9: MammaPrint: Key Features 64

Table 4.10: Siemens Oncogene Science Biomarker Group Reagents 65

Table 4.11: Colorectal Cancer Overview 66

Table 4.12: TNM Staging System for Colorectal Cancer 68

Table 4.13: Players in the Colorectal Cancer Molecular Diagnostic Space 68

Table 4.14: ArcticDx Genetic Test, Colo Risk 72

Table 4.15: Product Development Opportunities in Cancer Tumor Types 78

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 Rates 85

Table 4.19: Lung Cancer Facts 86

Table 4.20: Potential of Cancer Biomarkers in Drug Delivery and Development 92

Table 4.21: Barriers to Adoption of Biomarkers in Clinical Use 92

Table 5.1: Technology Trends in Cancer Testing 93

Table 5.2: Trends in Theranostics 93

Table 5.3: Market Trends in Cancer Testing 94

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

of Impact 94

Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in

Order of Impact 95

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

Cancer 99

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 Markers 122

Table 6.2: Genomic Health Oncotype DX Sales 124

Table 6.3: Drivers in KRAS Testing 127

Table 6.4: Factors Determining Third Party Payment for Advanced Cancer Tests 129

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

Conduct Business 133

Table 7.2: Focus Areas for the FDA Critical Path Initiative 139

Table A1: Tumor Markers Currently in Common Use 165

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