FDA Points To Premarket Clearance For Direct-To-Consumer Genetic Tests

02 Dec 2013

• By Sue Darcey

FDA tells direct-to-consumer genetic testing company 23andMe that it should immediately stop marketing its Personal Genome Service in a strongly worded, lengthy warning letter that experts say could provide guidance across the sector. The firm says it will address the agency’s concerns.

Providing health reports on an individual’s specific diseases and conditions, carrier status, health risks and drug responses are medical device uses requiring premarket approval or clearance, FDA tells direct-to-consumer genetic testing provider 23andMe Inc.

FDA’s Nov. 22 warning letter