Molecular Diagnostics in Cancer Testing --- Aarkstore Enterprise

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

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

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

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

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

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

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

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

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

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