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23andMe releases pharmacogenomics test that doesn’t require prescription

By Loren Bonner (APhA Pharmacy Today, January issue) on 1/4/2019

Upwards of 20 companies and more than 70 labs offer pharmacogenomics testing through a health care practitioner, giving patients and providers insight into how patients might respond to certain medications.

As pharmacists and other practitioners are trying to get up to speed with this new science, the consumer genetics testing company 23andMe announced in late 2018 that it gained FDA approval for a first-of-its-kind pharmacogenomics test that can bypass a practitioner completely.

According to reports from FDA and 23andMe, the test examines 33 different variants for eight different genes that produce drug metabolizing enzymes. This roughly translates to providing information on how a patient metabolizes about 50 different prescription and OTC medications. While 23andMe has yet to say when the test will be available to patients and for how much, FDA issued a strong statement warning patients and health care practitioners not to use the results to make any treatment decisions.

“FDA is basically saying ‘buyer beware,’ ” said Manju T. Beier, PharmD, BCGP, FASCP, senior partner at Geriatric Consultant Resources LLC and adjunct associate professor of pharmacy at the University of Michigan in Ann Arbor.

For some time now, Beier has been advocating that more pharmacists need to be educated about pharmacogenomics. She believes the recent news from 23andMe can serve as a wake-up call.

“This is yet another tool to utilize judiciously to manage and monitor therapy,” she said.

“Pharmacists are really furthest down the path on pharmacogenomics education,” said David Kisor, PharmD, director of pharmacogenomics education at Manchester University College of Pharmacy in Indiana. “The education that pharmacists are receiving through current certification programs, [continuing education], or graduate programs is necessary to put the pharmacist in the position to discuss this with the public appropriately.”

Kisor hopes the direct-to-consumer test from 23andMe, called the Personal Genome Service Pharmacogenetic Reports test, can ignite a broad discussion with the public about pharmacogenomics testing.

“When we look at educating individuals about pharmacogenomics, we tend to work from the health care provider down to the patient level, and this is really an opportunity to work at the patient or public level,” said Kisor.

Where’s the risk?
Some confusion and even contradiction surround how the new test is supposed to work. In press statements, both 23andMe and FDA acknowledged that the test allows patients to have more informed discussions with practitioners about managing their medications. FDA then reiterated that the information provided from the 23andMe results should not be used to start, stop, or change treatment, and the agency is requiring that the test label make that clear.

“Furthermore, health care providers should not use the test to make any treatment decisions, without additional testing,” wrote FDA in a November 1 statement.

“They [23andMe] want it verified by another independent pharmacogenomics testing service,” said Beier.

Kisor thinks 23andMe might be requesting this verification to cover their backs and avoid liability.

FDA issued an alert right after the 23andMe approval to explain to patients and practitioners that other genetic tests are available that are not FDA approved yet claim they can predict a patient’s response to specific medications. But no sufficient scientific evidence exists to support their use, the agency warned.

The Clinical Pharmacogenetics Implementation Consortium (CPIC) issues guidelines and gene-based prescribing recommendations based on a standard system for grading levels of evidence. According to Kelly Caudle, PharmD, PhD, BCPS, CPIC director, the genes that 23andMe has listed for the new test all have strong CPIC guidelines. (It’s not known, however, which drugs they are reporting back.) The CPIC guidelines help practitioners interpret genotypes and come up with appropriate prescribing decisions.

Take initiative
Pharmacists can educate health care providers and the public about pharmacogenomics testing, according to Kisor.

“Pharmacists should first take the initiative to train themselves in minimal [pharmacogenomics] competency,” he said. Information and competency statements from pharmacists can be found at the Genetics/Genomics Competency Center ( Kisor also thinks the American Society of Health-System Pharmacists statement on pharmacists’ involvement in pharmacogenomics is worth reading to “clue pharmacists into approaching education for themselves.”

Pharmacists can refer to the CPIC website ( to understand the evidence that exists for genotypes.

“I wish more clinicians were aware of pharmacogenomics,” said Caudle. “We have a working group to disseminate the guidelines because many are unaware they exist.”