FDA Approves Cancer Biomarker Test, CMS Suggests Insurance Coverage Options


Centers for Medicare & Medicaid Services proposed national coverage determination of the FoundationOne CDx test.

Last week, the FDA approved the FoundationOne CDx (F1CDx), a next-generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can discover mutations in 324 genes and 2 genomic signatures in solid tumors, according to a press release.

In support of the groundbreaking approval, the Centers for Medicare & Medicaid Services (CMS) issued a national coverage suggestion for the F1CDx.

The F1CDx is the second IVD to be approved and reviewed by the FDA and CMS under the Parallel Review Program, according to the release. This program increases Medicare access to novel technologies.

Under the FDA-CMS program, the agencies both review medical devices to speed the time to FDA approval and Medicare’s coverage of the device. The program is open to new technologies and devices that fall within the scope of Part A or Part B, according to the release.

“By leveraging 2 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,” said FDA Commissioner Scott Gottlieb, MD. “The FDA’s Breakthrough Device Program and Parallel Review with CMS allowed the sponsor to win approval for this novel diagnostic and secure an immediate proposed Medicare coverage determination within 6 months of the FDA receiving the product application.”

The CMS said that the F1CDx provides more information about various genetic mutations that can help improve the management of patients with cancer compared with other approved tests.

F1CDx sequences a patient’s tumor sample to detect mutations, alterations, and molecular changes, according to the release. Clinical testing suggests the test may be accurate nearly 95% of the time.

Based on the results, the novel test may be able to match patients with approved targeted therapies for patients with non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, or ovarian cancer, according to the CMS.

Additionally, since the test searches through hundreds of mutations, duplicative biopsies can be avoided, according to the release.

“The F1CDx can help cancer patients and their health care professionals make more informed care decisions without the often invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial,” said Jeffrey Shuren, MD, director of the FDA Center for Devices and Radiological Health. “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options.”

The CMS also proposed national coverage of the test for Medicare patients with advanced cancer who have not previously received NGS testing. The proposed plan provides coverage for NGS IVD tests to help patients and physicians make informed treatment decisions and can also increase enrollment in clinical trials, according to the release.

“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,” said Seema Verma, administrator of CMS. “Our proposal establishes clear expectations, while at the same time delivering better outcomes for the people we serve.”

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