FDA approves direct-to-consumer test, warns against others

After authorizing a genetic test from 23andMe Inc. (Mountain View, Calif.), FDA issued a warning against using unapproved tests to guide medical decisions.

On Oct. 31, FDA said the Personal Genome Service Pharmacogenetic Reports test from 23andMe may be marketed as a direct-to-consumer test to detect genetic variants that may be associated with a patient's ability to metabolize some medications. The test is authorized to detect 33 variants to help inform discussions with a healthcare provider...