Credit: Shutterstock photoFoundation Medicine ( FMI ) launched to a record high Friday after U.S. regulators approved its genomic test to match some cancer patients to Food and Drug Administration-approved therapies.
[ibd-display-video id=2996905 width=50 float=left autostart=true] By the closing bell on the stock market today , Foundation rocketed 17.7% to close at 62.60. The stock led IBD's 461-company Biotech industry group, which lifted a collective fraction.
The test, dubbed FoundationOne CDx, is a diagnostic tool for patients with solid tumors. It could help as many as one in three patients afflicted with any one of five common advanced cancers find approved therapies and help physicians identify opportunities for others to participate in trials.
FoundationOne CDx does this by assessing all classes of genomic alterations in 324 genes known to drive cancer growth. It is also approved as a companion diagnostic for patients with some types of lung, skin, colon, ovarian and breast cancer.
The test also reports genomic biomarkers, which can help determine whether a patient could benefit from some immunotherapies. An estimated half of all cancer drugs in development today are expected to have a companion biomarker, Foundation said in a news release.
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Today, many cancer patients don't receive biomarker testing, LUNGevity Foundation Chief Executive Andrea Ferris said in a prepared statement. Some cancer therapies work better in specific populations of patients.
"This FDA approval means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumor profile that can identify the therapies and clinical trials they could most benefit from," she said.
Further, the Centers for Medicare and Medicaid Services decided it would cover the test. The draft policy would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage for other solid tumors in the future. A final policy is set to come out in the first quarter of 2018.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
