ARTICLE | Clinical News
FDA approves direct-to-consumer test, warns against others
November 9, 2018 9:04 PM UTC
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...
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