NEW YORK, May 22, 2013 /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#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

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 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 18 2.1 Opening-up of Opportunities in Molecular Diagnostics 18 2.2 Impact of the Human Genome Project on Molecular Diagnostics 20 2.3 Considerations for Molecular and Clinical Diagnostics 20 2.4 Molecular Diagnostics in the Post-Genomic Era 23 2.5 Advances in Molecular Diagnostics Technologies 24 2.6 Oligonucleotide Array Platforms 26 2.7 Emerging Cancer Personalized Medicine Market 26 2.7.1 Predictive Cancer Molecular Diagnostics 28 2.8 Companion Tests for Drug Development 29 2.9 Opportunities for IVDMIA Companies 31

3. Cancer Diagnostics Molecular Testing Market 32 3.1 Market Description 36 3.1.1 Market Overview 36 3.1.2 Molecular Diagnostic Markers 37 3.1.3 Competitive Landscape 38 3.1.4 Sales and Marketing Strategies for Cancer Tests 40 3.1.4.1 North American Market 42 3.1.4.2 International Markets 43 3.1.4.3 Europe 43 3.1.4.4 Asia-Pacific 44

4. Molecular Diagnostic Tests for Cancer 45 4.1 Cancer Diagnostic Tests 45 4.1.1 Use of Genomics to Understand Cancer 46 4.1.2 Molecular Diagnostic Tools Solutions 48 4.1.3 Technology of Gene Expression Analysis 50 4.1.3.1 Amplify and Detect Diminished Amounts of RNA Consistently 50 4.1.3.2 Analyze Hundreds of Genes 51 4.1.3.3 Employ Advanced Information Technology 51 4.2 Breast Cancer 53 4.2.1 Cancer Prognostic Assays 55 4.2.1.1 Myriad Genetics (BRACA1 and BRACA2) 56 4.2.1.2 Genomic Health (Oncotype DX) 56 4.2.1.2.1 Single Gene Reporting (ER, PR, HER2) 59 4.2.1.2.2 Node Positive (N+) 59 4.2.1.2.3 Aromatase Inhibitors 60 4.2.1.2.4 Product Development 60 4.2.1.2.5 Product Development Opportunities in Breast Cancer 61 4.2.1.3 InterGenetics, Inc. 61 4.2.1.4 LabCorp (HER-2) 62 4.2.1.5 Clarient, Inc. (GE Healthcare) 64 4.2.1.6 BioTheronostics (AviaraDx) 65 4.2.1.7 Agendia B.V. (MammaPrint) 65 4.2.1.8 Oncogene Science (Wilex) 67 4.2.1.9 Ventana Medical Systems 69 4.2.2 Competition and Comparison of Methods 69 4.2.3 Competitive Structure and Market Share Analysis 70 4.2.3.1 Breast Cancer Molecular Diagnostic Testing Market Size 71 4.2.3.1.1 Global Market 71 4.2.3.1.2 U.S. Market 71 4.2.3.1.3 European Market 72 4.2.3.2 Market Forecasts 73 4.2.3.2.1 Revenue Forecasts 73 4.2.3.3 Market Drivers and Restraints 73 4.2.3.3.1 Market Drivers 73 4.2.3.3.2 Market Restraints 74 4.2.3.4 Breast Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 74 4.2.3.4.1 Breast Cancer Molecular Diagnostic Testing Assay Market Trends 74 4.2.3.4.2 Breast Cancer Molecular Diagnostic Testing Assay Technology Trends 74 4.2.3.4.3 Breast Cancer Testing Assay Strategic Recommendations 74 4.3 Colorectal Cancer Molecular Diagnostics Market 75 4.3.1 Colon Cancer Testing Platforms 77 4.3.1.1 Genomic Testing 77 4.3.1.1.1 IVD Multiplex Index Analysis (MIA) 77 4.3.1.1.2 The BRAF Test 77 4.3.1.1.3 KRAS 78 4.3.1.1.3.1 Background on KRAS Mutation 78 4.3.1.1.4 mSEPT9 82 4.3.1.2 Screening Test 82 4.3.2 Players in the Colorectal Cancer Space 83 4.3.3 Competitive Structure and Market Share Analysis 89 4.3.3.1 Colon Cancer Molecular Diagnostic Testing Market Size 89 4.3.3.1.1 Global Colon Cancer Testing Market 89 4.3.3.1.2 U.S. Colon Cancer Testing Market 90 4.3.3.1.3 European Colon Cancer testing Market 91 4.3.3.2 Market Forecasts 91 4.3.3.2.1 Revenue Forecasts 91 4.3.3.3 Market Drivers and Restraints 92 4.3.3.3.1 Market Drivers 92 4.3.3.3.2 Market Restraints 92 4.3.3.4 Colon Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 92 4.3.3.4.1 Colon Cancer Molecular Diagnostic Testing Assay Market Trends 92 4.3.3.4.2 Colon Cancer Molecular Diagnostic Testing Assay Technology Trends 93 4.3.3.4.3 Colon Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 93 4.4 Prostate Cancer Molecular Diagnostics Market 95 4.4.1 Screening for Prostate Cancer 96 4.4.1.1 PSA Screening Test for Prostate Cancer 96 4.4.1.2 PCA3 Screening Test for Prostate Cancer 97 4.4.1.3 Gen-Probe 99 4.4.1.4 Beckman Coulter (Danaher) Prostate Health Index 101 4.4.1.5 Opko Health 4KScore 101 4.4.1.6 Metabolon Prostarix DRE Urine Test 102 4.4.2 Tests after Positive Biopsy 102 4.2.2.1 Myriad Genetics (Prolaris) 102 4.2.2.2 Genomic Health (Genomic Prostate Score) 102 4.2.2.3 Bostwick Laboratories (ProstaVysion) 103 4.2.2.4 Metamark Genetics (Biopsy Test) 103 4.4.3 Tests After Negative Biopsy 103 4.4.3.1 Mitomics (Prostate Core Test) 103 4.4.3.2 MDxHealth (Confirm MDx) 104 4.4.4 Tests After Surgery 105 4.4.4.1 GenomeDx Sciences (Decipher) 105 4.4.4.2 Iris International (Nadia ProsVue) 105 4.4.5 Competition and Comparison of Methods 105 4.4.6 Competitive Structure and Market Share Analysis 106 4.4.7 Market Drivers and Restraints 107 4.4.7.1 Market Drivers 107 4.4.7.2 Market Restraints 107 4.4.8 Prostate Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 107 4.4.8.1 Prostate Cancer Molecular Diagnostic Testing Assay Market Trends 107 4.4.8.2 Prostate Cancer Molecular Diagnostic Testing Assay Technology Trends 108 4.4.8.3 Prostate Cancer Testing Assay Strategic Recommendations 108 4.5 Other Cancer Molecular Diagnostic Markets 111 4.5.1 Bladder Cancer 111 4.5.2 Ovarian Cancer 111 4.5.2.1 Incidence of Ovarian Cancer 111 4.5.2.2 Key Players in Ovarian Testing market 116 4.5.2.3 Ovarian Cancer Market Size 119 4.5.2.4 Ovarian Cancer Molecular Diagnostic Testing Market Size 119 4.5.2.4.1 Global Ovarian Cancer Testing Market 119 4.5.2.4.2 U.S. Ovarian Cancer Testing Market 120 4.5.2.4.3 European Ovarian Cancer testing Market 121 4.5.2.5 Market Forecasts 121 4.5.2.5.1 Revenue Forecasts 121 4.5.2.6 Market Drivers and Restraints 122 4.5.2.6.1 Market Drivers 122 4.5.2.6.2 Market Restraints 122 4.5.2.7 Ovarian Cancer Molecular Diagnostic Testing Assay Market and Technology Trends 122 4.5.2.7.1 Ovarian Cancer Molecular Diagnostic Testing Assay Market Trends 122 4.5.2.7.2 Ovarian Cancer Molecular Diagnostic Testing Assay Technology Trends 123 4.5.2.7.3 Ovarian Cancer Molecular Diagnostic Testing Assay Strategic Recommendations 123 4.5.3 Lung Cancer 123 4.5.4 Melanoma 130 4.6 Molecular Diagnostic Screening Test for Cancer 131 4.6.1 Extreme Drug Resistance assay (Oncotech EDR Assay) 132 4.6.2 Multidrug Resistance Protein (MRP) 132 4.7 Companion Diagnostic Tests for Cancer Therapeutics 133

5. Business 137 5.1 Technology and Market Trends 137 5.1.1 Technology Trends 138 5.1.2 Market Trends 139 5.2 M&A Activity 141 5.3 Partnerships 144 5.4 Competitive Analysis 147 5.4.1 Primary Competitors 153 5.4.1.1 Summary of Market Strengths, Weaknesses, Opportunities and Threats 154 5.4.2 Industry Challenges and Strategic Recommendations 155 5.4.3 Commercialization of Molecular Diagnostic Products 155 5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing 157 5.6 Intellectual Property Rights 173 5.6.1 BRCA1 and BRCA2 Gene Patents 174 5.6.2 Current Patent Disputes 174

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Molecular Diagnostics in Cancer Testing

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