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Informatics in Pharmacy

23andMe the First to Offer Direct to Consumer Pharmacogenomic Testing

January 8, 2019 By Dr. G, PharmD

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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.

Filed Under: Consumer Info, Medicine and Media

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acid base acidosis acute coronary syndrome alkalosis analgesics anaphylaxis aortic dissection arrhythmia Beta-Blockers biostatistics blood pressure cardiac markers CHA2DS2-VasC cocaine COVID-19 diabetes diabetes inspidius Guidelines heart failure Heparin hypersensitivity hypertension hypovolemic shock intubation ionotropes journal club lipids LMWH medication safety morphine conversions myocardial infarction needs work NOAC NSTEMI obstructive shock pharmacoeconomics pheochromocytoma pressors reference materials right mi sedation septic shock shock STEMI Updated 2020