Bowing to the Food and Drug Administration, genetic testing service 23andMe said last week that it would stop providing consumers with health information while its test undergoes regulatory review.
The decision was in response to a warning letter sent by the agency two weeks ago saying that the genetic test was a medical device that requires approval.
“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,” Anne Wojcicki, the chief executive of 23andMe, said in a statement.
The company will continue to take orders for new tests but will provide only ancestry information and raw data, without interpretations of the health implications. It said it might resume providing health data if it receives regulatory approval.
23andMe sought approval of certain of its tests in 2012 but did not provide information the FDA required. After the company began advertising on television, the agency ordered it to stop marketing its test.
The company then halted advertising, apparently hoping that it could stop “marketing” but continue selling. But it appears that regulators did not buy that distinction.
It is not clear how long it will take for the company to get regulatory approval. It appears it was having trouble satisfying the FDA, so it will most likely be months or longer.
The service, which costs $99, analyzes DNA from a saliva sample to tell people if they have higher- or lower-than-average risks for certain diseases and how they might react to certain medicines. It is offered directly to consumers.
The agency, in its warning letter, said consumers might take inappropriate actions based on the test results. But company supporters said that such concerns were unfounded.
The company said that customers who purchased the test before Nov. 22, the date of the warning letter, would still have access to health-related information. Customers who ordered the test on or after Nov. 22, the company said, would be eligible for a refund.
