FDA Tells Gene Testing Company to Halt Marketing
A company that offers genetic testing directly to consumers has been told to stop marketing its main DNA service until it receives approval from the U.S. Food and Drug Administration.
An FDA warning letter sent to California-based 23andMe says the company has failed to provide adequate evidence that its Personal Genome Service provides accurate results. The letter was issued Friday and posted on the FDA's website Monday, The New York Times reported.
The letter says the agency considers the service to be a medical device that requires approval.
"FDA is concerned about the public health consequences of inaccurate results from the PGS device," the letter states. "The main purpose of compliance with FDA's regulatory requirements is to ensure the tests work."
23andMe's service has been used by about half a million people. It claims to tell consumers whether they might be at increased or decreased risk for various diseases, among other things, The Times reported.