The U.S. Food and Drug Administration has given 23andMe clearance to begin selling kits for the genetic testing of Bloom Syndrome.
This is a rare recessive gene disorder that is characterized by shorter height and a predisposition to develop cancer. Parents of children with Bloom Syndrome don’t exhibit any symptoms of the disorder.
23andMe’s direct-to-consumer genetic test allows someone to see if they have a specific gene variant for Bloom Syndrome and helps parents know if they could potentially pass on the gene that would cause their children to have the disorder.
This is a significant ruling from the FDA. 23andMe had been ordered to stop selling the health reports associated with the at-home testing kits after not meeting the necessary FDA approval to do so back in 2013. The kits tested for 254 different kinds of disease markers. The FDA had classified these kits as medical devices for that reason and determined that it required regulatory approval before genetic information regarding health could be given to the public. This is the first time the FDA has approved this sort of test without a doctor’s approval.
It gives 23andMe a regulatory framework for future submissions. Anne Wojcicki
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,” says 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.
The approval is only for one type of screening kit but could open the door for approval of other types of genetic testing for the company. “It gives 23andMe a regulatory framework for future submissions,” CEO of 23andMe Anne Wojcicki wrote on a blog post.
“While this authorization is for a single carrier status test only, we are committed to providing US customers with health information once more tests have been through this process and we have a more comprehensive product offering,” she said.