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.