Do Genetic Tests Need Doctors? FDA Defends Its Challenge to 23andMe

Alberto Gutierrez doesn’t want to look like the bad guy who’s getting between you and your DNA. That’s not why he sent a warning letter to 23andMe, telling the company to immediately stop marketing its $99 genetic test to the masses. “We don’t have an issue with people getting their own DNA data,” says Gutierrez, who heads the Center for Devices and Radiological Health at the U.S. Food and Drug Administration. “We just have concerns with how it’s being interpreted.”

Those concerns have been mounting for four years, he says, and have taken on a new urgency as Google-backed 23andMe accelerates its mass-market push with national ads and a media campaign. To Gutierrez, mainstream marketing increases the risk that less sophisticated consumers might cut off their breasts or stop taking a life-saving drug after reading an analysis of their spit.