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,
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
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,