The FoundationOne CDx (F1CDx) is an NGS-based test designed to detect alterations in 324 genes relevant to non-small cell lung cancer, breast cancer, colorectal cancer, ovarian cancer and melanoma. F1CDx also provides information on microsatellite instability and tumor mutational burden.
Additionally, the CMS approved for coverage the F1CDx companion for in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient’s cancer and results are provided to the treating physician for management of the patient using a report template to specify treatment options.
“The final NCD will significantly improve access and coverage for Medicare beneficiaries to comprehensive genomic profiling and biomarker-driven treatments,” Troy Cox, Foundation Medicine’s chief executive, said in a statement. “We look forward to commercializing FoundationOne CDx by the end of March, providing the oncology community with the only FDA-approved broad assay for all solid tumors.”
Foundation Medicine picked up the FDA approval in early December on the same day the CMS proposed coverage of the test. The test will be available through Medicare and the Medicare Advantage plans provided by commercial payers. The company was the second after Exact Sciences to go through the parallel review process of regulatory and reimbursement decisions that was designed to reduce the time it takes for patients to access innovative and possibly life-saving healthcare advances.
The test parcels up the information it collects 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.
In moving away from the one test, one drug model that has defined companion diagnostics so far, the expectation is the the test will help reduce the burden on patients and accelerate the identification of the most appropriate treatment.