FDA orders maker of genetic test kit to stop selling product

Tuesday, November 26, 2013  

The Food and Drug Administration ordered the maker of a genetic testing kit to stop selling its product.

In a letter, the FDA said 23andMe markets its product as a method to determine risks for certain diseases and conditions. But the agency said there is no proof that the kit actually works as promised.

23andMe acknowledged that it sought FDA approval of the product but said it hadn't submitted information on time to the agency. The company has 15 days to respond to the letter or it could face fines and other enforcement actions.

The "Saliva Collection Kit and Personal Genome Service" also promises an analysis of a person's ancestry. "People with mixed ancestry, African Americans, Latinos, and Native Americans will also get a detailed breakdown," the website site states.

Get the Story:
FDA tells 23andMe to halt sales of genetic test (AP 11/25)
FDA warns maker of genetic-testing kit (The Washington Post 11/26)
F.D.A. Orders Genetic Testing Firm to Stop Selling DNA Analysis Service (The New York Times 11/26)