To Comply With FDA, 23andMe Won’t Give New Customers Genetic Analysis
The personal genetics startup 23andMe announced this evening that it will stop giving new customers access to health reports tied to their genes, after being warned by the FDA over compliance issues.
It is not discontinuing sales, however, as we initially thought based on the company’s wording. 23andMe said it would “comply immediately with the U.S. Food and Drug Administration’s directive to discontinue consumer access to its health-related genetic tests during the ongoing regulatory review process.”
However, that doesn’t mean that it’s stopping sales of new kits. Rather, new customers will only receive “raw genetic data without interpretation.”
It’s a departure from the company’s response of two weeks ago, which was to continue selling the kits but stop advertising them.
Mountain View, Calif.-based 23andMe had publicly apologized for being slow to respond, after the FDA complained of delays, The agency threatened seizure, injunction and civil financial penalties.
23andMe said tonight that it will continue offering access to its more than 250 health reports for customers who bought kits before Nov. 22, when it received the warning letter.
The FDA wants 23andMe to wait for clearance as a medical device before it can offer diagnostics to customers. It is concerned about people acting on information they receive about their genetics, or getting false complacency if the company’s testing mistakenly clears someone from risk.
However, the agency doesn’t yet offer classifications for many things 23andMe promises to do, so it will likely be a long road ahead to actually comply.
Here’s the notice now posted on 23andMe’s site, and a press release:
Welcome to 23andMe.
At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.
We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.
If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.
We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.
Upon entering the site, please confirm you understand the new changes in our services.
I understand that 23andMe only sells ancestry reports and raw genetic data at this time. I understand 23andMe will not provide health-related reports. However, 23andMe may provide health-related results in the future, dependent upon FDA marketing authorization.
Current 23andMe customers who received health-related results prior to November 22, 2013 will continue to have access to that information.
Customers who purchased kits before November 22, 2013 will still receive health-related results.
Customers who purchase or have purchased 23andMe’s Personal Genome Service (PGS) on or after November 22, 2013, the date of the Warning Letter from the FDA, will receive ancestry information, as well as their raw genetic data without interpretation. These new customers may receive additional health-related results in the future, dependent upon FDA marketing authorization. Customers who purchased kits on or after November 22, 2013 will be eligible for a refund. 23andMe will be sending an email with refund instructions to all eligible customers.