By Diagnostics World Staff
December 21, 2017 | The US Food and Drug Administration (FDA) recently approved the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test, Foundation Medicine’s FoundationOne CDx (F1CDx). The test can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type with about 94.6% accuracy.
Along with the FDA’s approval, the Centers for Medicare & Medicaid Services (CMS) has proposed coverage of the F1CDx, making this test the second IVD to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program.
CMS’s proposed national coverage determination of the F1CDx and other similar NGS IVDs is for Medicare beneficiaries with advanced cancer, who have not been previously tested using the same NGS technology and continue to seek further cancer therapy. The proposed national coverage determination provides coverage of NGS IVD 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.
“NGS unlocks new opportunities in genomic-based medicine helping oncologists match patients to available therapies,” Joydeep Goswami, president of clinical next-generation sequencing and oncology for Thermo Fisher Scientific, said in a press release commemorating the announcement. “While the clinical research community has embraced the technology for some time now, it's encouraging to see CMS recognize the value of NGS testing both from a patient and drug development perspective.”
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. 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.
F1CDx results are delivered in an integrated report that identifies alterations matched to FDA approved therapies, identifies additional alterations in genes known to drive cancer growth, furnishes information about genomic biomarkers, including microsatellite instability (MSI) and transient monocular blindness (TMB), provides relevant clinical trial information, and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.
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 news of F1CDx’s approval is not without some controversy. In November, Caris Life Sciences filed a patent infringement suit against Foundation Medicine in the United States District Court for the District of Massachusetts Boston Division, siting Foundation's willful infringement of Caris' patent rights by its FoundationOne, FoundationACT and FoundationOne Heme products.