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. Its 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 it needs 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).

Update: 23andMe has issued a statement on the matter, and sent a letter to its customers:

We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.

Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. 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 has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe

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FDA orders 23andMe to stop selling DNA-testing kits pending approval