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

SUMMARY

Introduction

Diagnostics can be used to identify subgroups of patients who may or may not benefi t from a companion drug, who may have adverse reactions to that drug, or who may require different doses of that drug because of their particular metabolic activity. The concept of companion diagnostics as an integral component of personalized medicine-RxDx-is an emerging and critical paradigm for drug development and use. What is driving that paradigm?

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• More than a dozen companion diagnostic tests are approved for use in the United States and guide the prescription of products in oncology, cardiovascular disease, and infectious diseases. What are the most successful RxDx products, and will their success encourage further development? Why are companies reluctant to abandon the blockbuster model in favor of personalized medicine?
• Personalized medicine continues to be heavily debated within the industry, and future growth depends on more attention from all stakeholders. What is each stakeholder's role in RxDx collaborations, and how can these collaborations drive development? What does each player have to offer the others to encourage development and reconcile debate? Why are parallel development programs critical?
• Reimbursement issues are an important factor that will determine whether the pharmaceutical industry is willing to invest in RxDx, but current reimbursement policies can be discouraging. What evidence must companies provide to third-party payers to demonstrate value and ensure reimbursement? What are the policies and issues surrounding reimbursement? With few RxDx products on the market and even fewer reimbursed, how can R&D costs ever be recovered?

Scope

• Key players: Abbott Diagnostics, Clinical Data, Dako, Genzyme Genetics.
• Challenges in RxDx development: technological challenges, regulation, drug labeling, reimbursement.
• Emerging companion diagnostics by therapeutic area: oncology, infectious diseases, cardiology, central nervous system (CNS) indications, diabetes, respiratory therapeutics; profi les of select companies working in RxDx.
• Outlook: future of companion diagnostics development, company buy-in, the affect of personalized medicine on prescription sales, the role of regulatory agencies.

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