The Food and Drug Administration is ordering 23andMe to stop selling its saliva collection kits for its personal genome service.
23andMe is a health and ancestry DNA start-up, founded by Anne Wojcicki in 2006. For $99, you receive a spit kit, provide 23andMe with a saliva sample, and send in your results. Within a few weeks, you receive a bunch of information about what your DNA says about you.
But now the FDA is accusing 23andMe of violating the Federal Food, Drug, and Cosmetic Act, it recently stated in a warning letter addressed to 23andMe CEO Anne Wojcicki. In the letter, the FDA claims that 23andMe marketed its saliva collection kit and personal genome service without clearance or approval.
Here's a summary of the FDA's claims:
- The kit is mis-branded: it sets out to diagnose an individual's carrier status, health risks, and drug response to about 254 diseases. The problem, according to the FDA, is that there is too much potential for false positives or false negatives when it comes to diseases like breast or ovarian cancer.
- So the FDA wants 23andMe to analytically or clinically validate all the claims it says its kit provides.
A spokesperson for 23andMe has provided Business Insider with the following statement:
"We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
23andMe must officially respond to the FDA by December 13, 2013.
Click over to Business Insider to read the full letter from the FDA.
This article originally appeared in Business Insider.