FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers

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On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare & Medicaid Services (CMS) at the same time proposed coverage of the F1CDx. The test is the second in vitro diagnostic to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries.

“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,” said FDA Commissioner Scott Gottlieb, MD

More About the F1CDx

The F1CDx test provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer. Additionally, based on individual test results, the new diagnostic can identify which patients with any of 5 tumor types may benefit from 15 different FDA-approved targeted treatment options. Its results provide patients and health-care professionals access to all of this information in one test report.

“With the run of one test, patients and health-care professionals can now evaluate several appropriate disease management options,” said Jeffrey Shuren, MD, Director of the FDA’s Center for Devices and Radiological Health (CDRH). 

How the F1CDx Test Works

The F1CDx detects gene mutations that may be found in any solid tumor. Moreover, it can be used as a companion diagnostic to identify patients with specific mutations who may benefit from certain FDA-approved treatments for non–small cell lung cancer, melanoma, breast cancer, colorectal cancer, or ovarian cancer. Importantly, the F1CDx can detect genetic mutations that are indicated for multiple FDA-approved treatments.

The device works by sequencing DNA from a patient’s tumor sample to determine the presence of gene mutations and alterations. It also detects certain molecular changes (microsatellite instability and tumor mutation burden). Clinical performance of the test was established through a least burdensome means by comparing the F1CDx to previously FDA-approved companion diagnostic tests that are currently used to determine patient eligibility for certain treatments. Results indicated that the test’s ability to detect select mutation types (substitutions and short insertions and deletions) representative of the entire 324-gene panel is accurate approximately 94.6% of the time.

The F1CDx had not been previously submitted for the FDA’s review because it is a laboratory-developed test, for which the agency has generally not enforced premarket review and other applicable requirements. However, at the test developer’s request, the FDA worked closely with them to help enter it into the agency’s newly established Breakthrough Device Program. Because of the test’s potential to consolidate multiple companion diagnostic claims for patients and health-care providers in a single test, the F1CDx was granted Breakthrough Device designation. Under the Breakthrough Device Program, the FDA provides intensive interaction and guidance to the company on efficient device development, which expedites evidence generation and the agency’s review of devices that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases for which no approved or cleared treatment exists or that offer significant advantages over the existing standard of care.

The FDA also reviewed the -F1CDx application using a coordinated, cross-agency approach; the clinical review was conducted by FDA’s CDRH with support from FDA’s Oncology Center of Excellence, while all other aspects of review and the final product approval determination were conducted by the FDA’s CDRH.

CMS Coverage Proposal

CMS also issued a proposed national coverage determination of the F1CDx and other similar next-generation sequencing in vitro diagnostics for Medicare beneficiaries with advanced cancer (ie, recurrent, metastatic, or advanced stage IV cancer), who have not been previously tested using the same next-generation sequencing technology and continue to seek further cancer therapy. The proposed national coverage determination provides coverage of next-generation sequencing tests to assist patients and their treating physicians in making informed cancer treatment decisions that improve health outcomes. Use of a test as a diagnostic also includes the ability to help patients and their treating physicians determine candidacy for cancer clinical trials. ■

The FDA granted approval for the F1CDx test toFoundation Medicine, Inc. For more information visit