WIKIMEDIA, SAM HOWZITLisa Casey, a San Diego resident and subscriber to 23andMe’s Personal Genome Service, complains in a lawsuit filed last week (November 27) that the company misled her about its product. Casey's beef with 23andMe is similar to that of the US Food and Drug Administration's. Earlier in November the agency told 23andMe to stop marketing its Personal Genome Service (PGS) because its determinations about health risks and disease carrier status are not clinically validated.
According to the lawsuit, Casey purchased the $99 genetic test in September 2013 and received an e-mail with her results on November 19. She bought the test after seeing advertisements from 23andMe that consumers could learn about their health risks and ancestry. “In fact,” the case states, “the PGS does none of those things and the results it provides are not supported by any scientific evidence.” The suit goes on to claim that Casey has suffered injury, in addition to losing money, as a result of 23andMe’s “false and misleading representations.”
It’s not clear what the injuries were that Casey suffered. The FDA has voiced its concerns that consumers might take drastic steps—such as prophylactic breast removal—based on erroneous results of the PGS. Although people can still buy 23andMe’s kits, the company has stopped marketing the product after the FDA’s crackdown. In a post on 23andMe’s website last week, CEO Anne Wojcicki wrote that “we stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well.” 23andMe might have to convince a judge and jury now, too.