23andMe's Personal Genome Service
23andMe has launched a revamped Personal Genome Service with a redesigned site and more than 60 genetic testing reports on carrier status, ancestry, wellness, and personal traits. The service costs $199.
The new release comes after 23andMe received 510(k) clearance from the US Food and Drug Administration in February for a Bloom syndrome test. As part of the authorization, the FDA said it is classifying carrier screening tests as class II, and intends to exempt similar devices from FDA premarket review.
"We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," 23andMe co-founder and CEO Anne Wojcicki said in a statement. "We are a better company with a better product as a result of our work with the FDA."