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Molecular Diagnostics: A Dynamic and Rapidly Broadening Market

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Molecular Diagnostics: A Dynamic and Rapidly Broadening Market

Publication date: January 2009

Keywords : clinical laboratory

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 ...

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Chapter 1
BACKGROUND AND SCOPE: 1.1. Background; 1.2. Focus of This Report; Chapter 2
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
Chapter 3
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 bioMérieux; 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 bioMérieux; OncoMethylome Sciences; Molecular Tests for Prostate Cancer; AdnaGen; CombiMatrix; Epigenomics; ExonHit Therapeutics and bioMérieux; 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; 3.2. Personalized Medicine; Pharmacogenomics and Companion Diagnostics:Moving Beyond Oncology; Cytochrome P450 and Drug Metabolism; Pharmacogenomic Test for Warfarin Response; Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs; Pharmacogenetics and Response to Antiretroviral Therapy (Anti-HIV Therapy); Other Molecular Diagnostics Personalized Medicine Tests; AutoGenomics; PGx Health (Part of Clinical Data); XDx; 3.3. Genetic Testing: For Inherited Disorders and Prenatal Diagnostics; Cystic Fibrosis; Prenatal Diagnosis; Abbott Molecular; CombiMatrix; Sequenom; Signature Genomic Laboratories; Tepnel; Ashkenazi Jewish Genetic Panel; Comparative Genomic Hybridization Microarrays; Other Current and Emerging Molecular Tests for Inherited Disorders; 3.4. Genetic Testing: Predicting Risk of Disease; Risk of Venous Thromboembolism; Predicting Risk of Developing Cancer; Myriad Genetics; deCODE Genetics; Risk of Developing Alzheimer’s Disease; Athena Diagnostics; Innogenetics; Celera; Risk of Cardiovascular Diseases; Celera; deCODE Genetics; Other Emerging Molecular Tests for Predicting Risk of Disease; Celera; CombiMatrix; deCODE Genetics; 3.5. Tables
Chapter 4
BUSINESS CONSIDERATIONS IN MOLECULAR DIAGNOSTICS: 4.1. Molecular Diagnostics Market Overview; 4.2. Major Trends in the Molecular Diagnostics Market; Automation, Ease of Use; Moving Selected Molecular Diagnostic Tests Nearer to the Patient; Growth in Number of New Biomarkers; Increasing Efforts on Clinical Validation of Tests; Increasing Number of Tests Commercially Available; Launching New Tests Through CLIA-Certified Laboratories; Impact of FDA Regulations; Growing Number of FDA-Cleared and Approved Tests; Consolidation (Acquisitions); Competition; Increasing Role of Personalized Medicine; 4.3. Personalized Medicine and Molecular Diagnostics; Treatment of Infectious Diseases; Companion Diagnostics and Targeted Therapies; Other Personalized Medicine Tests; 4.4. Major Challenges Facing Molecular Diagnostic Companies; Challenges Associated with Personalized Medicine Market Segment; Regulatory Issues and Considerations; Regulatory Issues and Considerations for Molecular Diagnostics Clinical Laboratories; Regulatory Issues and Considerations for Molecular Diagnostic Companies; Regulatory Issues and Consideration for Pharmaceutical Companies Developing Pharmacogenomic Therapies; Reimbursement of Molecular Diagnostics; Patient and Physician Education; Identification of New Biomarkers; Validation of Biomarkers and Diagnostic Tests
Chapter 5
EXPERT INTERVIEWS: Jeremy Bridge-Cook, PhD, Vice President, Luminex Molecular Diagnostics, Luminex Corporation, Austin, TX; David Craford, Vice President, Commercial Operations, Pathwork Diagnostics, Sunnyvale, CA; Amit Kumar, PhD, CEO and President, CombiMatrix Corporation, Mukilteo, WA; Fareed Kureshy, Founder, Chairman, President, and CEO, AutoGenomics, Carlsbad, CA; Jeffrey E. Miller, PhD, CSO, CEO, and Chairman, InVivoScribe Board of Directors,; InVivoScribe Technologies, San Diego, CA; Mansoor Mohammed, PhD, President and CEO, CombiMatrix Molecular Diagnostics (CMDX) (subsidiary of CombiMatrix Corporation), Irvine, CA; Oliver Schacht, PhD, CFO and CEO, Epigenomics Inc., Epigenomics AG, Berlin, Germany; John C. Schafer, President and CEO, DiagnoCure, Quebec, Canada; James White, CEO, Osmetech plc, Pasadena, CA; Matt Winkler, PhD, CEO and CSO, Asuragen, Austin, TX
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