The Food and Drug Administration (FDA) just approved a
Developed by Foundation Medicine, the test is designed for patients with advanced or widely spread cancers and will make gene profiling of tumors available to far more cancer patients than ever before. According to the announcement, the Centers for Medicare and Medicaid Services (CMS) has already proposed covering the test for patients in state-run insurance programs across the country.
Currently, patients can get tested for individual cancer genes if a drug is available to target those mutations. However, cancer experts say it’s a hit-and-miss approach that often leads to unnecessary biopsies and wasted time. The FoundationOne CDx, on the other hand, is capable of surveying 324 genes at once and can help predict success with treatments for a wide range of cancers, including those of the prostate, breast,
FDA regulators also noted that the new test would be able to help more patients find and enroll in clinical studies of new, experimental therapies for their cancers if no treatment is currently available for their condition.
Moving forward, CMS says public comments on the coverage proposal for this new cancer test will be taken for 30 days. A final decision is expected early next year, which, if approved, would be followed by setting a price for reimbursement.
Coverage is currently proposed for patients with recurrent, widespread or