KHN Morning Briefing

Summaries of health policy coverage from major news organizations

FDA Orders Halt To Marketing For DNA Test Kit

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).

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