FDA Reclassifies Next-Generation Sequencing Tests

The U.S. Food and Drug Administration (FDA) will change its regulatory approach to next-generation sequencing (NGS) tests, re-classifying them as moderate-risk medical devices. The tests will require the same level of scrutiny as direct-to-consumer genetic tests.

The FDA issued a guidance document indicating that this change will only apply to tests that help clinicians diagnose disease and not to pre-implantation embryo, fetal, or tumor tests. According to FDA Commissioner Scott Gottlieb, MD, the agency hopes that “the analytical validation recommendations laid out in this guidance spur the creation of consensus standards for NGS-based tests that will be developed by the community and potentially recognized by the FDA.”

Source: STAT News, April 12, 2018.