FDA Clearance of DTC Genetic Test Gets Mixed Reviews
February 23, 2015
(Medscape) – On February 19, the US Food and Drug Administration (FDA) authorized 23andMe to market a direct-to-consumer (DTC) carrier test for Bloom syndrome. The agency’s decision to classify such carrier screening tests as class II medical devices, and exempting them from premarket review, may pave the way for a return of DTC genetic testing. The decision and the open door, however, have garnered mixed reviews from genetic counsellors and clinicians.