Enabling Oncology Diagnostics: Predictive Biomarkers Based on Genes, Proteins, and Pathways

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Predictive Biomarkers for Targeted Therapies in Breast Cancer
  • Key Predictive Biomarkers for Trastuzumab Therapy
    • HER2
    • PTEN/Akt/PI3K Pathway
  • Endocrine Therapy
    • Hormone Receptors
    • HER2
• Predictive Biomarkers for Anti-EGFR Antibody Therapies in Colorectal Cancer
  • EGFR Expression
  • EGFR Mutations
  • EGFR Amplifi cation
  • KRAS Mutations
  • PTEN/PI3K/Akt Pathway
  • VEGF Pathway
• Predictive Biomarkers for EGFR TKI Therapies in Lung Cancer
  • EGFR Mutations
  • Secondary EGFR Mutations
  • EGFR Amplifi cation
  • KRAS Mutations
  • Matrix Metalloproteinases-9
• Biomarker-Based Diagnostics in Oncology
  • ER/PR Status
  • Overexpression of HER2
  • KRAS Mutations
• Consortia for Advancing Cancer Biomarker Research
  • Oncology Biomarker Qualifi cation Initiative
  • The Biomarkers Consortium
  • International Cancer Biomarker Consortium
• Key Players in the Cancer Biomarker-Based Diagnostics Market
  • Abbott
  • Agendia
  • bioTheranostics
  • Dako
  • DxS
  • Genomic Health
  • Monogram Biosciences
  • Rosetta Genomics
  • Ventana Medical Systems/Roche
• Recommendations for Streamlining Cancer Biomarker Development
  • Providing Tools and Resources for Cancer Biomarker Discovery and Development
  • Providing Guidelines and Incentives for Cancer Biomarker Validation
  • Developing a Fair Pricing Structure for Commercialization and Adoption
• Outlook
• Spectrum Expert Commentary:
  • Current Trends in Predictive Biomarkers for Targeted Therapies in NSCLC
    • A Diagnostic Test for Tarceva - A Long Time Coming
    • Impact on Current and Emerging Therapies for NSCLC
    • Future Applications of Companion Diagnostics for Predictive Biomarkers in Oncology
  • Current Trends in Predictive Biomarkers for Targeted Therapies in NSCLC, by Andrew Merron, Ph.D., analyst, Decision Resources

Tables

• 1. Select FDA-Approved Targeted Therapies
• 2. Select Cancer Biomarker-Based Diagnostic Tests for Diagnosis
• 3. Select Cancer Biomarker-Based Diagnostic Tests for Monitoring Disease Progression
• 4. Select Cancer Biomarker-Based Diagnostic Tests for Selecting Cancer Therapies
• 5. Select Cancer Biomarker-Based Diagnostic Tests for Prognosis
• 6. Recent Oncology Collaborations Between Pharmaceutical and Diagnostics Companies
• 7. Members of the Biomarkers Consortium

Figures

• 1. Representative Examples of Cancer Molecular Targets
• 2. Applications of Biomarkers in Cancer Management