FDA finalizes guidances for NGS-based tests

On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests. Unlike most IVDs that typically detect a limited number of predefined analytes for diagnosing pre-specified conditions, NGS-based tests can be used to detect millions of DNA changes in a single patient sample in one test session. This information can, in turn, be used in a variety of ways, including as a companion diagnostic for a drug therapy. FDA has recognized the importance of developing appropriate regulatory frameworks for NGS-based tests to stimulate the advancement of the field of precision medicine. This effort by FDA also comes close on the heels of the recent CMS and FDA parallel review and subsequent National Coverage Determination for NGS tumor profiling tests.