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Foundation Medicine gets FDA, Medicare approval for cancer test

The U.S. Food and Drug Administration approved Foundation Medicine Inc.'s in vitro diagnostic test to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.

The Center for Medicare and Medicaid Services also proposed coverage of the test, known as FoundationOne CDx, at the same time.

FoundationOne CDx is the second in vitro diagnostic test to be approved and covered after overlapping review by the FDA and CMS under the parallel review program, which enables earlier access to innovative medical technologies for Medicare beneficiaries.

The test provides information on many different genetic mutations that may help in the clinical management of cancer patients. In addition, it can identify which patients with any of five tumor types may benefit from 15 different FDA-approved targeted treatment options.

"Our belief is that profiling will increasingly become routine in clinical practice, so we have worked closely with Foundation Medicine to develop an extensive clinically and analytically validated platform that can support both existing and future companion diagnostic needs," Sandra Horning, Roche Holding AG's chief medical officer and head of global product development, said in a statement.

Roche entered a strategic collaboration with Foundation Medicine in 2015 to advance the progress of personalized treatments for cancer patients.