- Precision medicine may be about to take a big leap forward as CMS considers covering the costs of a new, FDA-approved next-generation sequencing (NGS) test that can identify key biomarkers for certain cancers.
The FoundationOne CDx (F1CDx) in vitro diagnostic test can detect genetic mutations in 324 genes and two genomic signatures in solid tumors, offering oncologists and patients a new, more personalized approach to choosing cancer therapeutics.
“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’s Center for Devices and Radiological Health (CDRH).
“With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options.”
The test is the second of its kind to be approved under the parallel review process between the FDA and CMS, said FDA Commissioner Scott Gottlieb, MD.
The collaboration allows CMS to start considering medical devices and similar innovations for coverage determinations at the same time the devices or tests are undergoing FDA review. The project aims to speed up the lengthy process of bringing new ideas to market while maintaining stringent oversight of potential offerings.
“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,” Gottlieb said.
“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 six months of the FDA receiving the product application.”
The test is unique due to its ability to test more genetic variations at one time than other companion diagnostics. This means fewer biopsies are necessary to determine treatment options, which could be a significant benefit for patients.
F1CDx can also pinpoint which of 15 existing FDA-approved cancer treatments would be most applicable to patients with one of five tumor types, the FDA added. Patients with non-small cell lung cancer, melanoma, breast cancer, colorectal cancer or ovarian cancer may be able to target their treatments more precisely with the help of the test.
At the same time, CMS has announced a proposal to cover the costs of future NGS in vitro diagnostic tests for Medicare beneficiaries with advanced cancer who are already in treatment, but haven’t engaged in precision medicine testing.
The proposed national coverage determination would widen the availability of such strategies, and might also identify more patients eligible for clinical trials.
“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.”