Foundation Medicine’s Cancer Gene Test Approved by the FDA

NEC member Foundation Medicine recently received approval from the U.S. Food and Drug Administration (FDA) for a new cancer gene test. The Cambridge-based company’s revolutionary, personalized diagnostic test, FoundationOne CDx, is able to detect all four classes of alterations in 324 cancer-related genes that cause solid tumors.  It can identify tumors found in the lungs, colon, breasts, ovaries, and skin to help determine possible uses of immunotherapies as well as which specific FDA-approved cancer therapies could be effective.

The FDA and Centers for Medicare and Medicaid Services (CMS) approved FoundationOne CDx as the first solid tumor comprehensive genomic profiling test in their Parallel Review program.  CMS issued a draft National Coverage Determination (NCD) for FoundationOne CDx which would provide coverage for diagnostic claims if approved.

“Today’s historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care,” said Troy Cox, chief executive officer at Foundation Medicine. “Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation. Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care. On behalf of the Foundation Medicineteam, I’d like to thank FDA and CMS for their leadership and collaboration as we continue to work through the parallel review process with a shared mission of transforming cancer care.”

The New England Council congratulates Foundation Medicine on this impressive accomplishment and wishes them luck as they continue to develop treatments for cancer.  Read more in the Boston Globe and Foundation Medicine’s press release.

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