For more than five years, 23andMe has sent out personalized DNA test kits, offering consumers hundreds of clinical reports on their genetic risk for everything from diabetes to prostate cancer. It’s mission to educate customers about their health and ancestry appears to have been dealt a blow, however, after the US Food and Drug Administration (FDA) said the company needs its approval. It’s told 23andMe to stop advertising its DNA-testing product until it gets the medical device classification it needs, which involves conducting studies of the kits to gain documented proof of their accuracy.
The agency is also worried that customers might take action, or not, based on test results that may or may not be correct. 23andMe has attempted to gain clearance in the past, but hasn’t done everything they need to get the green light. Make no mistake, a run-in with the FDA is not to be taken lightly: satisfying the agency’s requirements is going to be a long and expensive process. 23andMe now has to tell the agency exactly how it intends to gain marketing authorization for the device, or it could face regulatory action (which includes injunctions, seizures and hefty fines).