23andMe the First to Offer Direct to Consumer Pharmacogenomic Testing

Genetics company 23andme announced that they will be offering the first direct-to-consumer pharmacogenomics test starting this year. 23andMe has yet to say when the test will be available to patients and for how much

This is the first authorization of a direct-to-consumer report on pharmacogenomics and came through the FDA’s de novo classification process. With this authorization, the FDA has classified these direct-to-consumer pharmacogenetic reports as moderate risk that have special controls to ensure safety, effectiveness, and accuracy. This authorization enables 23andMe to report on numerous variants associated with pharmacogenetic response.  

23andMe’s test examines 33 different variants for eight different genes that produce drug-metabolizing enzymes, which provides information on how a patient metabolizes about 50 different prescription and OTC medications.

Patients are going to need help interpreting these results. While many drugs are metabolized by these enzymes, the clinical value of knowing this varies. Psychiatrists are especially concerned that patients may not be able to reliably interpret the data surrounding psyche drugs, which is inconclusive for many drug/gene combos.

One of the best places to help your patients interpret PGx data is CPIC. They have guidelines, evidence evaluation, and primary source information for most drug/gene pairs. According to Kelly Caudle, PharmD, Ph.D., BCPS, CPIC director, the genes that 23andMe has listed for the new test all have strong CPIC guidelines.