Abstract
The FDA has approved F1CDx, a comprehensive companion diagnostic test that can detect genetic alterations and two genomic signatures in any type of solid tumor. Patients with five common types of advanced cancer can be matched to one of 17 targeted therapies with this single test.
The FDA has approved F1CDx (FoundationOne; Foundation Medicine), the first comprehensive companion diagnostic test that can detect genetic mutations in any solid tumor.
F1CDx uses next-generation sequencing to assess genetic alterations in 324 genes involved in cancer growth. The diagnostic can be used to match a patient to one of 17 targeted therapies used to treat advanced cancers, including melanoma and breast, ovarian, lung, and colorectal cancers; 12 of these therapies are considered first-line treatment options. Results may also help physicians identify appropriate clinical trials for patients. F1CDx also reports two genomic signatures: microsatellite instability and tumor mutational burden.
Foundation Medicine estimates that about 30% of patients who have a relatively common type of cancer could be matched with an FDA-approved therapy using F1CDx. Previously approved companion diagnostics match one test to one drug, meaning patients might need to have multiple tests to fully determine their treatment options.
“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,” says Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health. “With the run of one test, patients and health care professionals can now evaluate several appropriate disease management options.”
David Fabrizio, cancer immunotherapy leader at Foundation Medicine, says the F1CDx will be adapted as new biomarkers and treatments are developed, and that working with the FDA to attain premarket approval will streamline the process to update the F1CDx's labeling in the future. “We're quite excited by the growth potential,” he says.
The Centers for Medicare & Medicaid Services issued a proposed national coverage determination for F1CDx the same day the test gained FDA approval. The approval is subject to a 30-day comment period and is expected to be finalized in the first quarter of 2018. Pricing for the test will be determined under the Protecting Access to Medicare Act, which is effective this month. This is the second in vitro diagnostic test to utilize the Parallel Review Program offered by the two agencies, which aims to facilitate earlier access to innovative medical technologies for Medicare beneficiaries.
Fabrizio credits the parallel review process for expanding opportunities in companion diagnostics, saying it provides “a clear link to reimbursement that wasn't available previously.” –Jordan-Calmes Miller