FDA to Review 23andMe 510(k) for Rare Syndrome

The Food and Drug Administration (FDA) has agreed to review a submission by 23andMe for a health report focused on Bloom syndrome, a rare condition. Google Inc.-backed 23andMe Inc. recently submitted to the FDA a revised 510(k) application for its direct-to-consumer genetic testing service focusing on Bloom syndrome, the Silicon Valley-based company said. In a June 20 blog post, 23andMe Chief Legal and Regulatory Officer Kathy Hibbs called the submission “an important step in our work with the FDA in the coming months.” “Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions. More importantly, for our customers, it marks a baseline on the accuracy and validity of the information we report back to them,” Hibbs said. In November 2013, the FDA told 23andMe to immediately stop marketing its Saliva Collection Kit and Personal Genome Service to consumers until the company received federal marketing approval for the product. At the time, the FDA said “serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.” For a fee, 23andMe, which is based in Mountain View, Calif., provided more than 200 personalized health and trait reports as well as genetic ancestry information. The FDA said it rejected 23andMe’s 2012 510(k) clearance applications after the company failed to provide requested information. “We are pleased to be moving forward with the FDA and committed to our company mission of empowering individuals with their genetic information,” Hibbs said. Takeaway: 23andMe is slowly taking steps to get FDA approval to use its genetic testing service to identify a rare health disorder.