Almost two years after the FDA first told 23andMe to halt sales on its mail-order direct-to-consumer genetic testing service for disease risks, the company has relaunched a version of its new Personal Genome Service (PGS), which now meets FDA standards.
“We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," 23andMe CEO Anne Wojcicki...
Google-backed 23andMe is finally relaunching its mail-order personal genome service -- just not in the United States. Instead, the company is launching in England, which has a different regulatory framework than the United States.
"These products are considered to be in the lowest risk category and so there is no requirement for any premarket assessment," a spokesperson for the Medications and...
23andMe's app.
In a public letter dated November 22, the Food and Drug Administration has instructed personal genome startup 23andMe to immediately stop selling its testing service until the offering receives de novo 510(k) clearance. Regulatory Focus first spotted the letter.
"[M]onths after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not...
