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Foundation Medicine Gains FDA Approval, CMS Coverage Proposal for NGS Cancer Profiling Test

This article has been updated with additional information from Foundation Medicine.

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Foundation Medicine's NGS-based genomic profiling test, FoundationOne CDx (F1CDx), the agency said today. Concurrently, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary national coverage determination for the test and others like it.

The decisions come after the FDA and CMS considered the test under the Parallel Review Program. F1CDx is the second IVD to be approved and covered as part of that program, which is voluntary and aims to reduce the time between FDA approval of a device and its coverage by Medicare.

"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 healthcare costs," said FDA Commissioner Scott Gottlieb in a statement.

"Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation," said Foundation Medicine CEO Troy Cox in a statement. "Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care."

F1CDx detects genetic variants in 324 genes known to drive cancer and looks for two genomic signatures — microsatellite instability (MSI) and tumor mutational burden (TMB) — in solid tumors of any type, which may help doctors with the clinical management of cancer patients according to professional guidelines. For example, the test results can help inform the use of immunotherapies, and other targeted treatments, and identify clinical trial opportunities for a patient.

In addition, for five tumor types — non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer — the test can be used as a companion diagnostic to identify patients with specific mutations who may benefit from 15 FDA-approved targeted treatments. According to Foundation Medicine, the test can inform treatment with 17 on-label targeted therapies, including 12 that are currently approved as first-line therapy for their respective indications. Of note, F1CDx can detect genetic mutations that are indicated for multiple FDA-approved treatments, whereas most previous tests only covered mutations relating to a single drug.

Foundation Medicine said that about a third of all patients with advanced cancers of one of the five types are expected to match with an FDA-approved therapy. The company expects the number of matched on-label therapies covered by FoundationOne CDx to increase over time as the firm and its biopharmaceutical partners pursue FDA approval for additional companion diagnostics on the platform.

"The F1CDx can help cancer patients and their healthcare 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, director of the FDA's Center for Devices and Radiological Health (CDRH), in a statement. "With the run of one test, patients and healthcare professionals can now evaluate several appropriate disease management options."

This summer, the FDA already approved another NGS test as a companion diagnostic for multiple treatments, Thermo Fisher Scientific's NGS-based Oncomine Dx Target Test. That test, which detects alterations in 23 genes, was cleared as a CDx for three drugs for non-small cell lung cancer. Thermo Fisher said at the time that it will seek an expansion of those indications.

The FDA evaluated the clinical performance of Foundation's F1CDx by comparing it to previously approved companion diagnostic tests that are currently used. The results showed that the test could accurately detect select mutation types — substitutions and short insertions and deletions — 94.6 percent of the time. Those mutations were representative of the 324 genes it covers.

The agency said that at Foundation Medicine's request, it worked closely with the company to enter it into its newly established Breakthrough Device Program. Under that program, the FDA provides guidance on efficient device development, which its said expedites the generation of evidence 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 clinical review of F1CDx was conducted by FDA's CDRH, which was supported by the agency's Oncology Center of Excellence. All other aspects of the review and the final approval determination were conducted by CDRH.

CMS, for its part, issued a proposed national coverage determination for F1CDx and similar NGS IVDs for Medicare beneficiaries with advanced cancer — meaning recurrent, metastatic, or advanced stage IV cancer — who have not been previously tested using the same NGS technology and who seek further cancer therapy.

Foundation Medicine said that the draft NCD proposes coverage for FDA-approved companion diagnostic claims and provides a pathway for additional coverage as evidence is developed on other solid tumor types. The company expects the final policy to issue during the first quarter of 2018, following public comment on the preliminary version and an administrative period.

The firm plans to make FoundationOne CDx commercially available after the NCD is finalized.