How Overcoming the Challenge of Biomarker Validation Can Pay Off for Drug and Diagnostic Developers

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Biomarker Opportunity: Driven by Personalized Medicine
• Biomarker Defi nitions: Moving Toward "Known Validity"
• The Importance of Biomarker Validation
• Biomarker Validation Process
• FDA Support for Biomarker Validation
  • "Home Brew" Tests
  • De Novo Tests
  • In Vitro Diagnostic Multivariate Assays
• Case Studies: Two Successful Genetic Profi ling Biomarker Tests
  • Genomic Health' s Oncotype DX
  • Agendia' s MammaPrint
• Current Environment for Biomarker-Based Tests Seeking FDA Approval
  • Notable Recent FDA-Approved Biomarker Diagnostics
    • Agendia' s MammaPrint
    • Nanosphere' s Two Nucleic Acid Biomarker Tests
    • Veridex' s GeneSearch Breast Lymph Node Assay
    • Fujirebio Diagnostics' Mesomark
    • Siemens Medical Solutions' Immulite
  • Reimbursement Challenges
    • Health Insurers' Policy Decisions
    • FDA Recommendations
  • Consortia to Standardize Biomarker Validation
    • Oncology Biomarker Qualifi cation Initiative
    • The Cancer Biomarkers Collaborative
    • The Severe Adverse Event Consortium
• Key Players in the Current and Emerging Biomarker Market
  • Affymetrix
  • Dako
  • Exagen Diagnostics
  • Genzyme Genetics
  • Myriad Genetics
  • Nanosphere
  • Panacea Pharmaceuticals
  • Roche Diagnostics
  • Third Wave Technologies
  • Ventana Medical Systems
  • Veridex
• Upside for the Future of Biomarkers

Sidebar:

• Oncotype DX and MammaPrint: How Different Are The Two Gene Expression Tests?

Tables:

• 1. Biomarker Type and Select FDA-Approved Examples
• 2. Select FDA-Approved Tests for Known Valid Biomarkers
• 3. Select Clinical Trials Testing for Biomarker Validation, as of January 2008
• 4. Comparison of Genomic Health' s Oncotype DX and Agendia' s MammaPrint
• 5. Select FDA Approvals of Biomarker Diagnostics, 2007
• 6. Cost of Select High-Value Molecular Diagnostic Biomarker Tests
• 7. Organizations That Facilitate Biomarker Research and Validation

Figures:

• 1. FDA Classifi cation of Biomarker Diagnostics for Approval
• 2. Regulations by the FDA and CMS Relating to Diagnostics and Overlapping Oversight
• 3. Key Molecular Diagnostic Company Revenues