Last night, the company posted a statement on its website, saying it has suspended its 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.”
The FDA said that 23andMe’s marketing of the kits for the purpose of diagnosing genetic disorders and disease made the product a regulated medical device under the Federal Food, Drug and Cosmetic Act (FDCA). Claiming the company had failed to meet deadlines for turning over documentation related to the required review process, it ordered 23andMe to stop marketing this aspect of the kits as of Nov. 22.
“We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation,” reads the statement from the company. “If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.”
Existing 23andMe customers who go the site are being asked to acknowledge the following statement before clicking through to the main part of the site:
“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.”
On the “Health” page of the site, 23andMe goes into more detail about what current customers can expect.
Those who received health-related results prior to Nov. 22, 2013 will continue to have access to that information, explains the company. “However, no new health-related updates will be provided to your account.”
And those who purchased their kits before the Nov. 22 date but had not yet received results will still receive the results of the health-related tests.
Anyone who purchased the kit on or after Nov. 22, will be limited to receiving ancestry information and raw genetic data.
“These new customers may receive additional health-related results in the future, dependent upon FDA marketing authorization,” reads the site. “Customers who purchased kits on or after November 22, 2013 will be eligible for a refund.”
The company says it will be contacting eligible customers via e-mail.
This is certainly not the end of the road for the company, as it has made clear in the wake of the FDA cease-and-desist that it intends to continue working with the regulator to prove the accuracy of its product.