The Landscape of Companion Diagnostics: Challenges, Opportunities, and Future Trends

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Why Companion Diagnostics?
• RxDx Market Status
  • Companion Diagnostic Tests on the Market
  • Key Current Players in Companion Diagnostics
    • Abbott Diagnostics
    • Clinical Data
    • Dako
    • Genzyme Genetics
• Determinants of Codeveloping Companion Diagnostics
  • Why Should Companies Codevelop Targeted Therapies and Companion Diagnostics?
  • Why Do Pharmaceutical Companies Need to Establish Parallel Programs?
• Economics of Producing Companion Diagnostics
• Challenges in Developing Companion Diagnostics
  • Technological Challenges
  • Regulation of Diagnostic Tests
    • United States
    • Europe
  • Drug Labeling
  • Reimbursement Issues and Challenges
    • Personalized Medicines
    • Payers
    • Reimbursement Policies
  • Coding Issues
  • Determining Prospects and Potential for Reimbursement
• Emerging Companion Diagnostics by Therapeutic Area
  • Oncology
    • Biodesix
    • bioMérieux
    • Celera
    • GE Healthcare
    • Monogram Biosciences
    • Roche
    • Source MDx
  • Infectious Diseases
    • Abbott
    • Monogram Biosciences
    • Roche
    • Visible Genetics
  • Cardiology
    • PGxHealth
    • LabCorp
    • Nanosphere
  • Central Nervous System Indications
    • Adlyfe
    • Curidium
    • Clinical Data
    • ExonHit Therapeutics
    • Vanda Pharmaceuticals
  • Diabetes
    • Perlegen
    • Tethys Bioscience
  • Respiratory Therapeutics
• Market Opportunities for Companion Diagnostics
  • Getting the "Buy-In" from Companies
  • Expanding Therapeutic Area Coverage
• Outlook
  • Will We See More Companion Diagnostics on the Market?
  • Will RxDx Negatively Affect Rx Sales?
  • Will More Companies Join the Personalized Medicine Bandwagon?
  • Will There Be More Codevelopment of Therapeutics and Diagnostics?

Sidebars

• Common Defi nitions of Terms Associated with Companion Diagnostics
• Regulation of Diagnostic Tests in the United States
• Third-Party Payers Infl uencing Reimbursement for Diagnostic Tests
• Case Study: An RxDx Partnership Informing HIV Treatment

Tables

• 1. Select FDA-Approved Companion Diagnostic Tests and Associated Therapeutics
• 2. Collaborations of Leading Companion Diagnostics Developers, 2007-2008
• 3. Select Companion Diagnostic Tests for Warfarin Dosing
• 4. Recent Key Collaborations for Companion Diagnostic Development
• 5. Advantages and Disadvantages of Establishing a Drug and Diagnostic Codevelopment Program
• 6. Comparison of the Pharma and Diagnostics Industries Business Models

Figures

• 1. RxDx Codevelopment Process
• 2. Potential Biomarkers to Guide Treatment with AstraZeneca' s Iressa (Gefi tinib)
• 3. Impact of Biomarkers on Therapeutic Development and Prescription
• 4. Benefi t of Companion Diagnostics in the Characterization and Validation of Targeted Therapeutics