Reuters – A test from Foundation Medicine Inc that can detect cancer-causing mutations in 324 genes has won approval from the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services, the agencies said.
The test, known as FoundationOne CDx (F1CDx), is only the second diagnostic test to receive co-ordinated regulatory approval from the two agencies under the Parallel Review Program, the agencies said in a statement on Thursday.
That program is designed to help beneficiaries of the federal Medicare program for the elderly get earlier access to innovative medical technologies.
Tests like FoundationOne can help doctors tailor cancer treatments to the genetic mutations driving a patient’s tumor.
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