資料來源：https://www.reuters.com/article/us-foundation-approval/foundations-cancer-gene-test-gets-u-s-fda-and-medicare-nod-idUSKBN1DU32T

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.

The FoundationOne CDx test also probes tumor samples for biomarkers linked with response to immunotherapy drugs. That includes Merck & Co Inc’s Keytruda, which in May won FDA approval for use in patients whose tumors carry a specific genetic glitch, regardless of where in the body the tumor is located.

The FoundationOne test is the first ever FDA-approved comprehensive companion diagnostic for multiple types of cancer. Previously, the FDA has approved such tests as companion diagnostics for drugs targeting a single genetic glitch.

Cancer experts are in disagreement as to whether testing tumors for mutations driving the cancer and picking drugs that target these mutations ultimately benefits patients.

FDA officials said the approval can help patients avoid the need for multiple biopsies for successive, single-gene tests.

“With the run of one test, patients and healthcare professionals can now evaluate several appropriate disease management options,” Dr Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

The Medicare approval is subject to public comment. The decision covers the FoundationOne test and similar tests from other companies for use by Medicare patients with advanced cancers who continue to seek treatment, the CMS agency said.

So far, insurance coverage of such tests has been spotty, largely because private insurers have viewed the tests as lacking adequate evidence of benefit.

The approval could “set an important precedent for coverage determinations by private insurers,” said Rebecca Eisenberg of the University of Michigan Law School and Harold Varmus of Weill-Cornell Medicine, in an article published on Thursday in the journal Science.