Services & Software

23andMe defies FDA order to halt DNA testing

23andMe continues to sell its genetic sequencing tests despite a government order to stop.


Google-backed genetic sequencing company 23andMe responded Monday to a Food and Drug Administration order to halt the sales of its popular at-home testing kits, but the FDA isn't going to like it.

The public order, issued on November 22, demanded that 23andMe cease sales of the kits "immediately," saying that they were being sold in violation of the Food, Drug and Cosmetic Act. The FDA order explained that it had requested compliance with the FDCA since July 2009, and that 23andMe has "clinically validated" its tests.

On Monday, 23andMe issued a brief statement saying that the company's relationship with the FDA is "extremely important" and that the company is aware that it hasn't responded to the FDA's requests in a timely manner.

23andMe did not respond to a request for comment on how the continued sales of the testing kits comply with the FDA request. CNET will update the story when we hear back.