FDA shortens NGS regulatory path

FDA announced new rules to streamline approval of next-generation sequencing (NGS)-based tumor profiling diagnostics. The agency said accredited third-party agencies, including the newly accredited New York State Department of Health (NYSDOH), may recommend in vitro diagnostics for 510(k) clearance without developers submitting a separate application.

FDA also said it approved the IMPACT diagnostic test from Memorial Sloan Kettering Cancer Center (New York, N.Y.) through the de novo premarket review pathway for low- to moderate-risk devices for which there are no predicate devices. The NGS-based test identifies mutations on 468 genes and other molecular changes in a tumor's genomic makeup. ...