Direct to Consumer Pharmacogenetic Test Now FDA Approved

Direct to Consumer Pharmacogenetic Test Now FDA Approved

On October 31, 2018, the U.S. Food and Drug Administration granted 23andMe authorization to sell tests for 33 pharmacogenetic variants directly to consumers.   The test is called the Personal Genome Service Pharmacogenetic test analyzes DNA from a self-collected saliva sample, and the report describes if a person has variants in certain genes that may be associated with a their ability to metabolize some medicines.  The intended use of the test is to provide information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider.

The test was approved based on its ability to accurately identify the variants and demonstration that patients could understand the reports.  However, the test report does not describe whether a medication is appropriate for a patient, and contains a warning statement noting that the consumer should not use the test results to stop or change any medication.  Pharmacists and other health care providers can use the CPIC guidelines to help interpret this test, however the 23andMe results should be confirmed using clinical pharmacogenetic testing. 


FDA press release 

CPIC guidelines

Additional information about medications with pharmacogenetic implications, including; allopurinol, atazanavir, carbamezepam, citalopram, clopidogrel, codeine, simvastatin and many others can be found in the Top 300 Pharmacy Drug Cards or the Top 100 Nonprescription Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Flash Card section.  If your institution does not provide access, ask your medical librarian about subscribing.

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