WIKIMEDIA, APERS0N23andMe, a California company at the forefront of personalized genetic testing and no stranger to controversy, is in hot water with the U.S. Food and Drug Administration (FDA). The agency put an end to the company’s marketing of its $99 Personal Genome Service (PGS) because the tests were not given regulatory clearance. “Hope you weren’t planning to give your relatives the gift of genetic insight through 23andMe this holiday season,” writes Kashmir Hill at Forbes.
The kits offer genetic information for consumers on 254 different diseases and conditions. In a warning letter to 23andMe CEO Anne Wojcicki, the FDA explains that the company submitted applications for some of these indications, but that “23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it.” The letter goes on to say that the agency has worked with the company since 2009 to help it comply with regulations, but “we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses.”
The company has had little by way of response, although the ...
