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Companion Diagnostics: Enabling Personalized Medicines in Cancer
Decision Resources, Inc., Oct 2006, Pages: 30
Companion diagnostics will play an increasing role in cancer care. Pharmaceutical companies developing targeted therapies for cancer must consider the potential benefi ts of developing a companion diagnostic. As they join the rush to identify critical biomarkers, however, they also need to consider technology options, potential diagnostics partners, and regulatory hurdles.
Get the Answers You Need to Shape Your Strategy
Companion diagnostics are becoming an integral part of the design and development of targeted cancer therapies. How can pharmaceutical companies identify which agents need to be developed in concert with a companion diagnostic and which do not? Is the inevitable stratifi cation of disease markets a reason to shy away from targeted therapies and companion diagnostics?
Developing targeted therapies and companion diagnostics is all about discovering and validating clinical biomarkers. Which diagnostics companies are developing biomarkers that might be potential targets for licensing or acquisition?
PCR, microarrays, and expression profi ling are being used to improve the sensitivity and selectivity of companion diagnostics. Which companies are developing key technologies?
What are the latest developments in this field?
Many companies forego FDA approval and instead develop companion diagnostics for use in CLIA-certifi ed laboratories. What are the advantages of going the CLIA route? Are all companion diagnostics likely to need FDA approval in the near term?
Scope
- Regulatory issues: CLIA regulations, FDA guidance on pharmacogenetic tests, and the Health and Human Services Secretary’s Advisory Committee on Genetics, Health, and Society.
- Companion diagnostics available for current products: Herceptin, Gleevec, EGFR, metabolizing enzymes.
- Companion diagnostics for CLIA labs: leading companies and products.
- Emerging technologies and products: review of technologies used for design of companion diagnostics, epigenetics, blood-based technologies, oncology biomarkers.
- Leading companies: profiles of select companies developing companion diagnostics.
- Outlook: a look ahead to the role companion diagnostics may play in drug development.
- Spectrum Expert Commentary: the view from an executive at an industry-leading company.
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