Flickr/dullhunk The Federal Food and Drug Administration seems to be getting in the way of medical advances, at least when it comes to genetic testing company 23andMe.

23andMe's goal is to give you access to your genetic information, and empower you with a roadmap of your health. It also gives the masses the opportunity to participate in scientific research regarding things like Parkinson's Disease and skin sarcomas.

In fact, the advancement of medicine hinges on collecting and sharing all of this information, Peter Huber, author of "The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine," said in a recent interview with Fox Business. Collecting all of this information, he says, is critical to curing disease and to keeping people healthy.

But now, thanks to the FDA, 23andMe's most comprehensive health product — the one that until recently provided raw data and potential medical implications in layman's terms — is currently no longer available for new customers.

Late last month, the FDA demanded 23andMe in a warning letter to stop marketing its DNA testing device. 23andMe has also since been slapped with a $5 million class action lawsuit.

There are two technical issues: 23andMe is selling a medical device without approval from the FDA; and it has failed to prove that it has clinically validated its personal genome service. The latter oversight sounds serious but it's more a matter of 23andMe not giving the FDA the correct paperwork in a timely manner than a fundamental flaw in the technology 23andMe is developing.

23andMe says it adheres to the highest scientific standards and the same laboratory processing standards currently applied to physician-ordered tests.

"Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 — known as CLIA," 23andMe CEO Anne Wojcicki said recently in a statement. "These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data."

23andMe has previously marketed its product as a way to learn about your ancestry, and receive a glimpse into genetic health risks. But if you look closely at its terms of service, 23andMe says that "many of the genetic discoveries that we report have not been clinically validated." That statement is a reference to the fact that the product is as-yet unapproved by the FDA.



It's clearly problematic. 23andMe should have followed the FDA's rules before continuing to market its product. This seems like a basic error that would never have occurred at a grown-up medical device company.



But the third issue is a matter of principle: the FDA has a history of preventing ordinary members of the public from getting their hands on self-diagnostic devices that would improve their health or let them make informed choices about their bodies.

Genetic tests don't actually tell people they have a disease. The results need to be interpreted by a doctor, so the fear is that people will start — wrongly — self-diagnosing themselves is somewhat misplaced.

On top of that, the FDA historically has a pretty rigid, slow, and outdated approval process. For 25 years, the FDA banned at-home HIV tests on a somewhat similar theory that people would get scared, make rash decisions, or even commit suicide, Huber says. "But at the time, the only defense was against spreading disease was to know you had it so you would stop spreading it," he said.

Until 23andMe sorts everything out with the FDA, it will only continue to provide new customers with ancestry information. Pre-existing customers will still be able to access their health data.

But new customers won't be able to take advantage of it. They'll never learn whether they need to see a doctor or not — perhaps until it is too late.



Check out some more discussion of 23andMe below.