If you were planning to purchase a $99 DNA test kit for the holiday season, you may have to put those plans on hold. The U.S. Food and Drug Administration ordered 23andMe, a Google-backed DNA analysis company, to stop sales of its genetic testing kit since they're being sold without marketing clearance or approval.
"FDA is concerned about the public health consequences of inaccurate results from the PGS device," the agency said in a statement. "The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work."
23andMe sells a $99 Saliva Collection Kit and Personal Genome Service, which tells users if they're genetically predisposed to some 260 diseases and conditions, as well as makes specific health recommendations. Once you receive your kit, you're supposed to register your specific bar code and then send in a sample of your saliva following the provided instructions and using the provided pre-paid packaging.
"We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission," Catherine Afarian, a spokeswoman for 23andMe, said in an email to Bloomberg. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
In all likelihood, 23andMe will eventually clear the legal hurdles it needs to in order to continue selling its DNA testing kit, though no timeline has yet been established.