FDA approves first test to detect cancer-causing mutations in hundreds of genes

Read Advisory Board's take on this story.

FDA on Thursday approved the first test to detect cancer-causing mutations in more than 300 genes, and CMS proposed covering the test under Medicare.

CMS and FDA said the test is the second to receive coordinated regulatory approval from two federal agencies under the Parallel Review Program, which was created to help Medicare beneficiaries get quicker access to new medical treatments, Reuters reports.

FDA approves F1CDx for sale in US

FDA approved Foundation Medicine's test—known as FoundationOne CDx, or F1CDx—for sale in the United States under the agency's Breakthrough Device Program. The test evaluates tumor samples for biomarkers that are linked with being responsive to immunotherapy drugs. According to Reuters, the test can help health care providers tailor cancer treatments to the genetic mutations that cause cancerous tumors, and reduce the number of tests patients must undergo to test for gene mutations.

F1CDx can test for genetic mutations in 324 genes, as well as two genomic signatures in all types of solid tumors, MedPage Today reports. FDA said the test is about 94.6% accurate when detecting certain mutation types from the 324-gene panel.

F1CDx is the first test approved by FDA as a comprehensive companion diagnostic for various types of cancer. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, in a statement said, "With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options."

FDA Commissioner Scott Gottlieb said, "By leveraging two policy efforts aimed at expediting access to promising new technologies, we've been able to bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs."

CMS proposes Medicare coverage of F1CDx

In addition, CMS on Thursday proposed covering F1CDx and similar tests for Medicare beneficiaries with advanced cancers that are still seeking treatment. According to Reuters, CMS' decision to authorize Medicare coverage for the test is open for public comment.

Rebecca Eisenberg of the University of Michigan Law School and Harold Varmus of Weill-Cornell Medicine in an article published Thursday in Science wrote that CMS' decision could "set an important precedent for coverage determinations by private insurers."

CMS Administrator Seema Verma said, "Through parallel review and collaboration, we speed access to innovative diagnostics, so that doctors are better able to deliver the best quality care to their patients and patients have access to these state-of-the-art tests." She added, "Our proposal establishes clear expectations, while at the same time delivering better outcomes for the people we serve" (Steenhuysen, Reuters, 11/30; Fiore, MedPage Today, 11/30; Morse, Healthcare Finance News, 12/1; FDA release, 11/30).

Advisory Board's take

Deirdre Saulet

Deirdre Saulet, Oncology Roundtable

There are two major reasons for cancer programs to be excited by the concurrent FDA approval and CMS recommendation for reimbursement of FoundationOne CDx.

First, as the field of precision medicine has advanced, there has been an explosion in the number of companies and tests providing genomic profiling. However, because these are categorized as laboratory-developed tests, they do not have to be reviewed by FDA. It can also be extremely difficult for providers, patients, and payers to understand the validity, utility, and value of these tests. Foundation Medicine's request to work closely with FDA for Breakthrough Device designation may provide a roadmap for future tests and certainly will help providers make informed treatment decisions.

Second, CMS' recommendation that Medicare pay for the test is an essential step to improving access to precision medicine. Currently, reimbursement for these tests and the corresponding treatments can be a major barrier for organizations, requiring hefty time, personnel, and administrative investments. If Medicare sets coverage for this test, it would be instrumental to laying the groundwork and setting the bar for additional coverage for other indications and tests.

To learn more about precision medicine innovations and how your organization can realize its benefits, check out our new briefing, "Innovations in Medical Oncology."

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