June 18, 2008

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

Research and Markets (http://www.researchandmarkets.com/research/441498/the_landscape_of_c) has announced the addition of Decision Resources, Inc.'s new report "The Landscape of Companion Diagnostics: Challenges, Opportunities, and Future Trends" to their offering.

This report offers a comprehensive analysis of the companion diagnostics market:

- the drivers for continued growth

- impact on personalized medicine

- the importance of overcoming hurdles of drug-diagnostic codevelopment in achieving market success for companion diagnostics


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?

Key Topics Covered:

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


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


Drug Labeling

Reimbursement Issues and Challenges

Personalized Medicines


Reimbursement Policies

Coding Issues Determining Prospects and Potential for Reimbursement

Emerging Companion Diagnostics by Therapeutic Area





GE Healthcare

And more....




Companies Mentioned:

- 454 Life Sciences

- Abbott

- Abbott Diagnostics

- Adlyfe

- Agendia

- Agilent

- Arca Discovery

- Arup Laboratories

- AstraZeneca

- Asuragen

- Biodesix

- BioGenex

- bioMerieux

- Biosite

- Bristol-Myers Squibb

- Celera

- Chugai

- Clinical Data

- Cogenics

- C-Path

- Curidium

- Dako

- Delphic Diagnostics

- Eli Lilly

- ExonHit Therapeutics

- GE Healthcare

- Genaissance Pharmaceuticals

- Genentech

- Genomic Health

- Genzyme Genetics

- GlaxoSmithKline

- ImClone

- Ipsen

- Isis

- Kimball Genetics

- LabCorp

- Lipomics

- Meradex

- Merck

- Merck KGaA

- Monogram Biosciences

- Nanosphere

- Novartis

- OSI Pharmaceuticals

- Oxford Genome Sciences

- Perlegen

- Pfizer

- PGxHealth

- PGXL Laboratories

- Prometheus Laboratories

- Roche

- Source MDx

- Tethys Bioscience

- Third Wave Technologies

- Vanda Pharmaceuticals

- Ventana Medical Systems

- Visible Genetics

- Vysis

- Wafergen Biosystems

For more information visit http://www.researchandmarkets.com/research/441498/the_landscape_of_c.