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

Published by: Decision Resources

Published: Jun. 5, 2008 - 35 Pages


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 Definitions 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 (Gefitinib)

3. Impact of Biomarkers on Therapeutic Development and Prescription

4. Benefit of Companion Diagnostics in the Characterization and Validation of Targeted Therapeutics

Abstract

Diagnostics can be used to identify subgroups of patients who may or may not benefit 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?

Get the Answers You Need to Shape Your Strategy
  • 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; profiles 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.


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