By Anne Wojcicki
Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers in the US.
This is also the first-time the FDA has granted authorization to market a direct-to-consumer genetic test, and it gives 23andMe a regulatory framework for future submissions. 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.
The FDA has been incredibly responsive throughout our review and the agency has demonstrated its support for direct to consumer genetic testing. We will continue to work with the FDA to ensure that all future health submissions meet the agency’s standards.
It’s been a challenging and exciting time for consumer genetics. Our customers support and the stories they shared along the way make my job worthwhile. I will continue to provide our customers with updates on our blog and by email. We’ve also posted more information about the authorization here.