Trends in the Commercialization of Biomarkers: Tests and Companies

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• The Increasing Importance of Biomarkers
• A Wide Variety of Biomarker Technologies and Test Formats
• Oncology Biomarkers: Companion Diagnostics for Targeted Cancer Therapies
  • Overview
  • Commercial Success: Biomarker Tests for HER2/NEU/ERB2 Used with Herceptin in Breast Cancer
  • New Biomarker Tests: Possible Solutions for Prognosis and Therapy Selection in Breast Cancer
  • Biomarker Tests for Chronic Myelogenous Leukemia Incorporated Throughout Gleevec Development
• Biomarkers Used for Drug Dosing
  • Overview
  • Camptosar
  • Coumadin
• Profi les of Select Companies
  • Dako (Glostrup, Denmark)
  • Roche Diagnostics (Basel, Switzerland)
  • Genomic Health (Redwood City, California)
  • Agendia (Amsterdam, the Netherlands)
  • Third Wave Technologies (Madison, WI)
  • Genzyme Genetics (Framingham, MA)
  • Veridex (Raritan, NJ)
• Lessons Learned
  • Opportunities
  • Challenges
• Outlook
  • Biomarkers and Target Diseases
  • Advantages of a Platform Technology
  • Reimbursement Issues
  • Validation and Clinical Trials
  • Coordination of Product Development and Business Strategies

Tables

• 1. Major Technologies Currently Used for Biomarker Assays
• 2. Select Biomarkers Included in Drug Labeling
• 3. Select Commercialized Biomarkers, Analyte-Specifi c Reagents, and Products in Advanced Stages of Development

Figures

• 1. Applications of Biomarkers in Cancer Management
• 2. EGFR Family
• 3. Approximate Percentages of Drug Labels in the United States That Include Pharmacogenomic Information or Information Regarding Recommended or Required Tests

Sidebars

• FDA Biomarker Defi nitions
• Targeting EGFR-In Search of Biomarkers
• FDA Guidance on In Vitro Diagnostic Multivariate Index Assays