23andMe releases pharmacogenomics test that doesn’t require prescription
The news has implications for pharmacists as well as the public
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.
Based on 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.
David Kisor, PharmD, director of pharmacogenomics education at Manchester University College of Pharmacy in Indiana, 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.
“Pharmacists are really furthest down the path on pharmacogenomics education,” said Kisor. “The education that pharmacists are receiving through current certification programs, [continuing education], or graduate programs are necessary to put the pharmacist in the position to dis-cuss this with the public appropriately.
“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.”
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 statement.
“They [23andMe] want it verified by another independent pharmacogenomics testing service,” 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.
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.
For the full article, see the January 2019 issue of Pharmacy Today at www.pharmacytoday.org.