Abstract
Introduction
Companion diagnostics will play an increasing role in cancer care.
Pharmaceutical companies developing targeted therapies for cancer must
consider the potential benefits 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 profiling 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: profi les 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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