The FDA’s recent move to give 23andMe permission to market this country’s first direct-to-consumer genetic test, for Bloom syndrome, goes beyond the one in 107 Jews of Ashkenazi descent who are carriers of the rare disorder. At the same time as the agency gave the Mountain View, Calif.-based personal genetics company the go-ahead on its Bloom syndrome carrier test, the FDA also moved to classify autosomal recessive carrier status tests as class II medical devices and exempt them from premarket review.
“We’re excited that they have created a regulatory path forward for direct-to-consumer genetic testing,” 23andMe chief medical officer Jill M. Hagenkord, MD, tells CAP TODAY. “Historically, this kind of model hasn’t existed. We’ve had other over-the-counter, home-use tests like the HIV test. This is the first time we’re doing it for genetic testing.”
My latest in CAP TODAY’s “Put it On the Board” section. Read the whole shebang.