NEW YORK (GenomeWeb) – Foundation Medicine has decided to submit its next-generation sequencing cancer profiling test FoundationOne for parallel review by the US Food and Drug Administration and the Centers for Medicare and Medicaid Services.
FoundationOne is a test that analyzes patients' solid tumors for alterations in more than 300 genes and identifies treatments they will likely benefit from. The FDA has also decided to review FoundationOne through its Expedited Access Pathway for breakthrough devices, since there is a "large unmet need for comprehensive genomic profiling of tumors," the company said in a statement.
Foundation is seeking FDA approval for the test as a tool to identify which patients will benefit from FDA-approved treatments, and also as a tool that can direct patients to clinical trials according to the molecular features of their tumors. "If approved, FoundationOne could be the first FDA-approved comprehensive genomic profiling assay to incorporate multiple companion diagnostics to support precision medicine in oncology, including an indication for use as a companion diagnostic across a diverse range of solid tumors," Foundation added.
In anticipation of having to evaluate an NGS test for companion diagnostic use, the FDA held a public workshop earlier this year with test developers to discuss how it should evaluate the preanalytical, analytical, and clinical validity aspects of such tests, and to consider how they should be labeled.
The Parallel Review pathway, meanwhile, enables test developers to simultaneously obtain premarket approval and clearance through the FDA and a national coverage determination through CMS — a six to nine-month process by which CMS determines if it will pay for a product or service that it deems "reasonable and necessary" for the Medicare population.
Although the agencies have touted that parallel review can expedite the time it takes to commercially launch a product and garner reimbursement, few test developers have utilized the strategy. Exact Sciences is the only firm to successfully navigate parallel review for its colorectal cancer DNA screening test Cologuard by conducting a 10,000-patient study.
Following discussions with FDA and CMS, Foundation estimated the agencies could complete their parallel review of FoundationOne in the second half of 2017. While the test is being reviewed, CEO Michael Pellini said that the company will continue to work with Medicare contractors and Palmetto's MolDx program to expand local coverage determinations for genomic profiling tests like FoundationOne. To date, a number of Medicare contractors have issued LCDs outlining coverage criteria for genomic sequencing panels in advanced non-small cell lung cancer.
"Pursuing avenues at both the local and national levels maximizes the opportunity for Medicare beneficiaries with cancer to have access to FoundationOne," Pellini said in a statement.
The company also believes that FDA approval of FoundationOne as a platform that comprises multiple companion diagnostics will also bolster its pharmaceutical partnerships. "We believe this approach, which is designed to expedite approval of additional biomarkers on FoundationOne, both accelerates and de-risks companion diagnostic approval for our biopharma partners seeking a coordinated regulatory strategy for therapeutic drug approval," Pellini added.