The FDA has approved the FoundationOne CDx (or F1CDx), a breakthrough cancer diagnostic test developed by Cambridge-based biotech Foundation Medicine. F1CDx detects gene mutations that may be found in any solid tumor. This information can be used by physicians to manage cancer patients. 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, which extends beyond the previous “one test for one drug” model.
“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, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH).
Based on previous testing conducted by Foundation Medicine, it is estimated that approximately 1 in 3 patients across five common advanced cancers are expected to match with an FDA approved therapy. The number of matched on-label therapies indicated on FoundationOne CDx is expected to increase over time as Foundation Medicine and its biopharma partners pursue FDA approval for additional companion diagnostics on the platform. Today, approximately 50 percent of new cancer drugs in development are projected to have a companion biomarker.
Concurrent with FDA approval, Centers for Medicare and Medicaid Services (CMS) issued a proposed national coverage determination of the F1CDx and other similar diagnostic tests for Medicare beneficiaries with advanced cancer (i.e., recurrent, metastatic or advanced stage IV cancer) who have not been previously tested using the same technology and continue to seek further cancer therapy.
The proposed national coverage determination provides coverage of these 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.
This determination was made under the FDA-CMS Parallel Review Program, where the agencies concurrently review medical devices to help reduce the time between the FDA’s approval of a device and Medicare coverage. This voluntary program is open to certain premarket approval applications for devices with new technologies and to medical devices that fall within the scope of a Part A or Part B Medicare-benefit category and have not been subject to a national coverage determination.
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. (Source: Centers for Medicare and Medicaid Services Website, 30 November, 2017)