The agency says the tests haven't been proven effective.
The Washington Post: FDA Warns Maker Of Genetic-Testing Kit
The Food and Drug Administration has ordered the maker of a popular genetic-testing kit to halt sales of its heavily marketed product, saying the mail-order tests haven’t been proven effective and could dangerously mislead people about their health. The move came in a sharply worded letter to 23andMe, a California start-up backed by Google. The company says that its Personal Genome Service can detect more than 240 genetic conditions and traits, flagging a person’s vulnerability to heart disease, breast cancer and other illnesses (Dennis, 11/25).
The New York Times: F.D.A. Demands A Halt To A DNA Test Kit’s Marketing
In a crackdown on genetic testing offered directly to consumers, the Food and Drug Administration is demanding that the Google-backed company 23andMe immediately cease marketing its main DNA service until it receives marketing clearance from the agency (Pollack, 11/25).
The Wall Street Journal: Genetic Test Service 23andMe Ordered To Halt Marketing By FDA
U.S. regulators ordered genetic-testing company 23andMe Inc. to stop marketing its $99 mail-order kit, citing the risk that false results could cause consumers to undergo unnecessary health procedures such as breast-cancer surgery. The warning to the Google Inc.-backed company from the Food and Drug Administration follows a debate that has grown as hundreds of thousands of people have turned to direct-to-consumer genetic tests for clues about disease risk and ancestry (Loftus, 11/25).