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Foundation Medicine gets nod from FDA and Medicare for cancer test
CHICAGO (Reuters) - A test from Foundation Medicine Inc that can detect cancer-causing mutations in 324 genes has won simultaneous approval from the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services, the agencies said in a statement on Thursday.
The test, known as FoundationOne CDx, is only the second diagnostic test to receive coordinated regulatory approval from the two agencies under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries.
The tests are designed to help doctors tailor cancer treatments to the genetic mutations driving a patient’s tumor.
Reporting by Julie Steenhuysen, Editing by Rosalba O'Brien
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