Table of Contents
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 bioMerieux
- Screening for Colorectal Cancer: Stool-Based DNA Screening
- Exact Sciences
- OncoMethylome Sciences
- NorDiag
- Colorectal Cancer and K-RAS Mutations
- 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
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 Alzheimerfs Disease
- Athena Diagnostics
- Innogenetics
- Celera
- Risk of Cardiovascular Diseases
- 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
References
Company Index with Web Addresses
TABLES
- Table 2.1. Selected Nucleic Acid Amplification Technologies and Selected
Companies that Use These Technologies
- Table 2.2. Selected Examples of Companies with Proprietary Microarray or
Other Multiplex Technology: Moving Beyond Multiplex PCR Assays
- Table 3.1. Selected Companies Developing and/or Marketing Molecular
Diagnostic Tests for Oncology (Both Solid Tumors and Hematological Cancers):
Risk, Diagnostic, Prognostic, and Personalized Medicine Tests
- Table 3.2. Selected Companies Developing and/or Marketing Molecular
Personalized Medicine Tests; Pharmacogenomics and Companion Diagnostics:
Moving Beyond Oncology
- Table 3.3. Selected Companies Developing and/or Marketing Molecular
Diagnostic Tests for Inherited Disease or Prenatal Diagnosis
- Table 3.4. Selected Companies Developing and/or Marketing Molecular Tests
for Prediction of Disease Risk
- Table 3.5. Other Selected Companies Developing and/or Marketing Molecular
Diagnostic Tests
- Table 4.1. Selected Recent Corporate Acquisitions in Molecular Diagnostics
- Table 4.2. Valid Genomic Biomarkers in the Context of Approved Drug Labels
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