Aggregated News
Bowing to the Food and Drug Administration, the genetic testing service 23andMe said Thursday 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 Thursday evening.
“Our goal is to work cooperatively with the F.D.A. to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”
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...
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 Thursday evening.
“Our goal is to work cooperatively with the F.D.A. to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”
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...