Foundation’s Medicine Receives FDA, CMS Approval for NGS Cancer Profiling Test
The USFDA has now green signalled Foundation Medicine’s in vitro diagnostic test for solid tumor cancers. This diagnostic tool is designed to help physicians identify which patients would benefit from more than a dozen FDA-approved targeted treatment options and determine candidacy for clinical trials. The Centers for Medicare and Medicaid Services (CMS) concurrently submitted a preliminary National Coverage Determination for the device, proposing coverage for Medicare patients.
“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, M.D. “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.”
FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is also indicated as a companion diagnostic for patients with
certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications.Foundation Medicine parcels up the information into reports designed to help physicians match each patient to an approved targeted therapy, immunotherapy or clinical trial. These reports show which FDA-approved drugs use the test as a companion diagnostic—there are currently 15—and have led Foundation Medicine to frame F1CDx as an “easy button” for physicians.
Assuming the CMS decision is finalized after the 90-day public comment administrative period, the test will become available through Medicare and the Medicare Advantage plans provided by commercial payers.
The parallel processing of regulatory and reimbursement decisions will cut the time it takes for patients to access the test.
“Today we know that many people with cancer do not receive biomarker testing, let alone the comprehensive genomic testing they need to be efficiently matched to the best therapeutic option,” said Andrea Ferris, President and CEO of LUNGevity Foundation. “This FDA approval means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumor profile that can identify the therapies and clinical trials they could most benefit from. Along with the preliminary national coverage determination, this has the potential to democratize next-generation sequencing, lowering the barriers for patients treated in the community to access these biomarker-driven treatments.”
“Comprehensive genomic profiling is the gateway to precision medicine. This decision from the FDA and CMS, which may lead to coverage for Medicare patients, represents an important step forward in improving patient and clinician access to precision medicine – both in setting a new quality standard for this type of testing and offering potentially improved healthcare coverage,” said Ankur R. Parikh, DO, Medical Director of Precision Medicine, Cancer Treatment Centers of America. “Access to important genomic information is a critical step in being able to offer innovative and targeted treatment options.”
“Today’s historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care,” said Troy Cox, chief executive officer at Foundation Medicine. “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. 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. On behalf of the Foundation Medicine team, I’d like to thank FDA and CMS for their leadership and collaboration as we continue to work through the parallel review process with a shared mission of transforming cancer care.”
