In response to a request from the Food and Drug Administration (FDA), 23andMe will no longer provide consumers with health-related information based on their genome.
In a news release posted on its website on Thursday, the company said it’s temporarily suspending these services while it continues discussions with the FDA. The agency questioned whether the Google-backed company’s direct-to-consumer genetic testing service received the proper approval from the FDA for ensuring the safety of the public’s health. The company has said that its reports are educational and informational, not diagnostic, but the FDA raised concerns that consumers could make medical decisions based on their results.
Consumers who purchased test kits prior to the FDA’s warning letter, which was issued on Nov. 22, will still have access to their health-related genetic results on the company’s website, and can still see their genetic lineage or ancestry reports. But for the time being, their health information will no longer be updated with new interpretations based on the latest studies, as the company had been doing.
Those who purchased kits on or after Nov. 22 will be eligible for a refund, or, if they prefer, they can still receive ancestry-related information and their raw genetic data, without analysis of what that data means. If they choose the latter option, customers may eventually receive interpretations of their data, if the FDA decides that such analysis meets its requirements for providing consumers with reliable information that won’t result in undue harm.