The U.S. Food and Drug Administration ruled in November that the kit sold by the most prominent of these companies, 23andMe, was a “medical device” that hasn’t received regulatory marketing approval.
Wait, spitting in a tube requires the same scrutiny as a pacemaker or glucose monitor for diabetics? Well, the FDA says so because 23andMe linked your DNA information to health-related data: scientific associations for risks of diseases or how fast you metabolize drugs. The accuracy of the results – and the strengths of the scientific conclusions about your SNPs and health information – have not been proven to FDA’s satisfaction.
Health freedom advocates are crying, “Foul!” Your DNA is yours, right? Correct. But when a third-party gives you medical information about your DNA, the process must meet strict regulations.
Read the full, original story: Let’s get personal about your genome
