FDA Clears 23andMe For Its Direct-To-Consumer Genetic Carrier Test

The Food and Drug Administration (FDA) cleared 23andMe to market its direct-to-consumer (DTC) genetic carrier test for Bloom syndrome. The Mountain View, California-based company got a regulatory green light for its spit test kit and chip array platform for Bloom syndrome, a rare disease that primarily affects individuals of Ashkenazi Jewish descent. 23andMe picked up the clearance through the agency's de novo regulatory pathway, which is reserved for low- to moderate-risk devices with no market precedent. The FDA is also classifying autosomal recessive carrier screening tests as class II, allowing the products to forgo premarket . . .