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
For more information, please visit : http://www.aarkstore.com/reports/Molecular-Diagnostics-in-Cancer-Testing-36109.h
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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.
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
For more information, please visit : http://www.aarkstore.com/reports/Molecular-Diagnostics-in-Cancer-Testing-36109.h
Contact :Sanaa
Aarkstore Enterprise
Tel : +912227453309
Mobile No: +919272852585
Email : contact@aarkstore.com