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A multiplex test that can analyze tumors for over 200 genes is
now available from Foundation Medicine Inc., the Wall Street
Journal reported today. The test will be used by Novartis,
Sanofi SA, Johnson & Johnson and Celgene to analyze patients in
early-stage clinical trials of new cancer drugs to identify
patients most likely to benefit from the drug and to accelerate the
drug approval process. An example of an expedited approval using
genetic testing is the approval of the drug Xalkori developed by
Prizer, Inc. to treat patients with a rare form of lung cancer. The
cancer has been linked to a gene called ALK. Pfizer used the
correlation and a genetic test for the marker to quickly select
patients most likely to benefit from the treatment. The drug was
approved in just four years based on studies involving a total of
255 patients. This is a significant advancement. Historically, it
is reported that the cost to develop a new drug takes up to a
decade, thousands of patients and $1 billion in research and
development.
There are several tests on the market that analyze a single
gene, one at time or maybe a handful of genes. However, just
testing one gene isn't enough in complex diseases like cancer
which are now known to involve the interaction of many genes. Dr.
William Pao, director of personalized cancer medicine at Vanderbilt
University Medical Center, Nashville, Tennesee noted that testing
patients for each gene related to a cancer or therapy would be
"very onerous, expensive and time-consuming. The nice thing
about platforms like the one Foundation has is that it detects all
of them at the same time."
The Journal reported that a commercial version of the test was
made available last week with a list price of $5,800.
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