Molecular Diagnostics: A Dynamic and Rapidly Broadening Market

Molecular Diagnostics: A Dynamic and Rapidly Broadening Market published by Insight Pharma Reports in January, 2009. This report consists of 284 pages and the price starts from US $ 2995.

Introduction

Abstract

Molecular diagnostic applications in the areas of oncology, personalized medicine, inherited disorders, prediction of genetic disease risk, and many others are rapidly increasing in number as this burgeoning field expands beyond infectious disease testing. This report focuses on these newer applications of molecular diagnostics, analyzing:

• Established and up-and-coming technologies
• The activities of more than 35 companies
• More than 300 current and emerging molecular diagnostic tests for disease applications and genetic testing
• Business considerations associated with product development, commercialization, and marketing
• Regulatory issues
• Challenges facing companies developing molecular diagnostics and/or companion diagnostics and targeted therapies
• Major trends in the molecular diagnostics market, such as the increasing number of tests that are commercially available

The molecular diagnostics market is exploding. New genes and biomarkers are continually being identified and clinically validated, increasing the number of different tests available. The requisite technology and instruments are advancing in tandem. While many companies offer tests that detect only one or a few genetic changes, some companies have now developed tests capable of detecting large numbers of these changes. Many companies are taking their tests through the traditional diagnostics market strategy of gaining FDA clearance, while others have chosen a different strategy and are offering tests through their own CLIA-certified laboratories. These and other dynamics are effecting rapid change in this evolving field. Molecular Diagnostics: A Dynamic and Rapidly Broadening Market analyzes the emerging applications and technologies, marketplace trends, and business considerations for companies in this space.

The molecular diagnostics market is already quite large. It is estimated that the worldwide market for in vitro diagnostic kits and reagents sold by diagnostic companies to clinical laboratories may be approximately $3 billion or greater in 2008. It is more difficult to estimate the market size for proprietary clinical tests offered by companies through either their own CLIA-certified laboratories or other clinical laboratories. However, this can be a promising opportunity. For example, Myriad Genetics and Genomic Health saw a jump in molecular diagnostic revenues of 53% and 132%, respectively, over the past two years.

Molecular Diagnostics: A Dynamic and Rapidly Broadening Market considers major trends, including movement toward near-patient testing, growth in the number of new biomarkers, increased effort on clinical validation of tests, increased competition, consolidation in the field, regulatory issues and their impact on laboratories and companies, and the increasing role played by personalized medicine, among others. Technologies discussed include non-amplified probe-based assays, cytogenetics and fluorescent in situ hybridization, amplification technologies, microarrays, and DNA methylation assays.

Current and emerging applications of molecular diagnostics are reviewed and grouped into the following categories: oncology (diagnostic, prognostic, and personalized medicine tests); personalized medicine, pharmacogenomics and companion diagnostics outside of oncology; genetic testing for inherited disorders and prenatal diagnosis; and predicting genetic risk of disease. The activities of more than 35 companies are discussed. We also consider some of the challenges facing molecular diagnostic and pharmaceutical companies developing pharmacogenomic therapies, such as issues regarding reimbursement, patient and physician education, and the validation of new biomarkers and diagnostic tests. We conclude with 10 exclusive industry expert interviews.

Table of Contents

• BACKGROUND AND SCOPE
• 1.1. Background
• 1.2. Focus of This Report

• CURRENT AND EMERGING TECHNOLOGIES
• 2.1. Nonamplified Probe-Based Assays
• 2.2. Cytogenetics and Fluorescent In Situ Hybridization (FISH)
• 2.3. Polymerase Chain Reaction (PCR) and Other Amplification Technologies
• 2.4. Microarrays and Other Multiplex Technologies
• 2.5. DNA Methylation Assays
  • Epigenomics
  • OncoMethylome Sciences
  • Orion Genomics
  • Rubicon Genomics
• 2.6. Other Current and Emerging Technologies

• CURRENT AND EMERGING APPLICATIONS OF MOLECULAR DIAGNOSTICS: MOVING BEYOND INFECTIOUS DISEASE TESTING
• 3.1. Oncology: Diagnostic, Prognostic, and Personalized Medicine Tests
  • Testing for HER2/neu Overexpression in Breast Cancer
  • Testing for Epidermal Growth Factor Receptor
  • Analysis of the Expression of Multiple Genes for Breast Cancer
  • Prognosis and Treatment Decisions: Current and Emerging Tests
    • Agendia
    • bioTheranostics
    • Genomic Health
    • Ipsogen
    • Tests in Development for Prediction of Breast Cancer Metastases
  • Analysis of the Expression of Multiple Genes for Other Cancer Applications: Current and Emerging Tests
    • Agendia
    • bioTheranostics
    • Genomic Health
    • Pathwork Diagnostics
  • Analysis of Lymph Nodes to Detect Metastasis of Breast Cancer
  • Other Molecular Tests for Breast Cancer
    • Abbott Molecular
    • AdnaGen
    • Celera
    • ExonHit Therapeutics and bioMerieux
  • Screening for Colorectal Cancer: Stool-Based DNA Screening
    • Exact Sciences
    • OncoMethylome Sciences
    • NorDiag
  • Colorectal Cancer and K-RAS Mutations
    • DxS
    • Qiagen
  • Other Molecular Tests for Colorectal Cancer
    • AdnaGen
    • DiagnoCure
    • Epigenomics
    • ExonHit Therapeutics and bioMerieux
    • OncoMethylome Sciences
  • Molecular Tests for Prostate Cancer
    • AdnaGen
    • CombiMatrix
    • Epigenomics
    • ExonHit Therapeutics and bioMerieux
    • Gen-Probe
  • Leukemias and Lymphomas
    • Abbott Molecular
    • Asuragen
    • Cepheid
    • CombiMatrix
    • InVivoScribe Technologies
    • Roche Molecular Diagnostics
    • Selected Other Companies with Molecular Tests for Leukemia and Lymphoma
    • Outside the United States
  • UGT1A1 Genetic Variants
    • Third Wave Technologies
    • AutoGenomics
  • DNA Methylation Tests and Cancer
    • Epigenomics
    • OncoMethylome Sciences
    • Orion Genomics
    • Rubicon Genomics
  • Human Papillomavirus and Cervical Cancer Screening
  • Other Current and Emerging Molecular Tests for Oncology
    • Abbott Molecular
    • Asuragen
    • Dako
    • DxS
    • Myriad Genetics
    • Roche Molecular Diagnostics

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