FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions

News Release

 

FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions

04/06/2017 11:18 AM EDT

The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.

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