FDA Authorizes 23andMe to Market Genetic Testing For Bloom Syndrome

The FDA has classified the Bloom Syndrome carrier screening tests as class II, meaning the kits have special controls in place for direct-to-consumer marketing. The kits are also intended for exemption from FDA pre-market reviews, according to the FDA. “The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health said.

That last quote is really interesting.