Molecular Diagnostics: A Rapidly Shifting Commercial and Technology Landscape

Table of Contents

Chapter 1 BACKGROUND AND SCOPE

Chapter 2 CURRENT AND EMERGING TECHNOLOGIES

• 2.1. Nonamplified Probe-Based Assays
• 2.2. Cytogenetics and FISH
• 2.3. PCR and Other Amplification Technologies
• 2.4. Microarrays
• 2.5. DNA Methylation Assays
  • Companies Focusing on Methylation and Cancer Diagnostics
    • Epigenomics
    • OncoMethylome Sciences
    • Orion Genomics
    • Rubicon Genomics
• 2.6. Other Current and Emerging Technologies

Chapter 3 CURRENT AND EMERGING APPLICATIONS OF MOLECULAR DIAGNOSTICS

• 3.1. Infectious Disease Diagnostics
  • Human Immunodeficiency Virus
  • Hepatitis C Virus
  • Hepatitis B Virus
  • Molecular Tests for Blood Screening
  • Chlamydia and Gonorrhea
  • Human Papillomavirus and Cervical Cancer
  • Methicillin-Resistant Staphylococcus aureus
  • Other Current and Emerging Infectious Disease Diagnostics Tests
• 3.2. Molecular Oncology Tests
  • Analysis of the Expression of Multiple Genes and Cancer Prognosis
  • Analysis of Lymph Nodes to Detect Metastasis of Breast Cancer
  • Screening for Colorectal Cancer: Stool-Based DNA Screening
  • Leukemias and Lymphomas
  • DNA Methylation Tests and Cancer
  • Other Emerging Molecular Diagnostics Tests for Oncology
    • Abbott Molecular
    • DiagnoCure
    • ExonHit Therapeutics
    • Gen-Probe
    • Roche Diagnostics
• 3.3. Genetic Testing: Tests for Inherited Disorders and Prenatal Diagnostics
  • Cystic Fibrosis
  • Prenatal Diagnosis
  • Ashkenazi Jewish Genetic Panel
  • Other Current and Emerging Molecular Tests - Inherited Disorders
• 3.4. Genetic Testing: Predicting Risk of Disease
  • Risk of Venous Thromboembolism
  • Predicting Risk of Developing Cancer
  • Other Emerging Molecular Tests for Predicting Risk of Disease
• 3.5. Personalized Medicine: Pharmacogenomics and Companion Diagnostics
  • Cytochrome P450 and Drug Metabolism
  • Targeted Cancer Therapies and Companion Diagnostics Tests
  • Testing for HER2/neu Overexpression in Breast Cancer
  • Testing for Epidermal Growth Factor Receptor (EGFR)
  • UGT1A1 Genetic Variants
  • Pharmacogenetics and Response to Antiretroviral Therapy
  • Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs
  • Other Molecular Diagnostics Personalized Medicine Tests
    • AutoGenomics
    • DxS
    • Myriad Genetics
    • OncoMethylome Sciences
    • PGxHealth (part of Clinical Data)

Chapter 4 BUSINESS CONSIDERATIONS IN MOLECULAR DIAGNOSTICS

• 4.1. Molecular Diagnostics Market
• 4.2. Major Trends in the Molecular Diagnostics Market
  • Rapidly Growing Market; Growth Rates Vary by Segment
  • Automation, Ease of Use
  • Moving Molecular Diagnostics Tests Nearer to the Patient
  • Growth in Number of New Biomarkers; Efforts to Demonstrate Clinical Utility
  • Increasing Number of Tests Commercially Available
  • Growing Number of FDA-Cleared and FDA-Approved Tests
  • Consolidation in IVD
• 4.3. Personalized Medicine and Molecular Diagnostics: Impact on the Pharmaceutical Industry
  • Treatment of Infectious Diseases
  • Companion Diagnostics and Targeted Therapies
  • Prevention of Adverse Drug Reactions
• 4.4. Major Challenges Facing Molecular Diagnostics Companies
  • Regulatory Issues and Considerations
    • Regulatory Issues and Considerations for Molecular Diagnostics Clinical
    • Laboratories
    • Regulatory Issues and Considerations for Molecular Diagnostics
    • Companies
    • Regulatory Issues and Considerations for Pharmaceutical Companies
    • Developing Pharmacogenomic Therapies
  • Reimbursement of Molecular Diagnostics
  • Patient and Physician Education
  • Identification of New Biomarkers; Validation of Biomarkers and Diagnostics Tests

Chapter 5 EXPERT INTERVIEWS

• Fareed Kureshy, MBA
  • Chairman, President and CEO
  • AutoGenomics, Carlsbad, CA
• David H. Persing, MD, PhD
  • Executive Vice President, Chief Medical and Technical Officer
  • Cepheid, Sunnyvale, CA
• Geert Walther Nygaard
  • CEO
  • Epigenomics AG, Berlin, Germany and Oliver Schacht
  • CFO and CEO
  • Epigenomics, Seattle, WA
• Shuqi Chen, PhD
  • President, CEO, and Chairman
  • IQuum, Marlborough, MA
• Jorge Leon, PhD
  • President, Leomics Associates
  • Former Acting Chief Scientific Officer
  • Orion Genomics, St. Louis, MO
• James White
  • Chief Executive Officer
  • Osmetech, Pasadena, CA

Chapter 6 SELECTED COMPANY PROFILES

• Abbott Molecular (aka Vysis)
• Agendia
• AutoGenomics
• BD and BD GeneOhm
• Cepheid
• Digene
• Genomic Health
• Gen-Probe
• Luminex
• Nanogen
• Osmetech and Osmetech Molecular Diagnostics
• Prodesse
• Qiagen
• Roche Molecular Systems
• Third Wave Technologies

Appendix

• CHI INSIGHT PHARMA REPORTS - MOLECULAR DIAGNOSTICS SURVEY ANALYSIS