FDA approves another one of 23andme's products: their first "pharmacogenetic" test

(November 4, 2018)

On Wednesday, October 31, the FDA announced that it had approved the marketing of yet another over-the-counter genetic test developed by 23andMe Inc. The new test, "Personal Genome Service Pharmacogenetic Report" provides information on eight drug metabolizing genes, and will help a patient know how quickly or slowly their body is likely to metabolize drugs associated with a particular gene. The results report won't provide specific drug names, since the intent of the test is not to cause a patient to switch treatments. The FDA recommends that patients take an additional test with an "independent" pharmacogenetics testing service before making such a decision.

Perhaps due to the FDA's concerns about the possibility of the public misconstruing the purpose of the test, on Thursday it issued a warning against the "use of many genetic tests with unapproved claims to predict patient response to specific medications."

While this is the first FDA test of its kind to be approved for direct-to-consumer marketing, similar kinds of pharmacokinetic lab tests have been available for years when obtained at the request of a health care provider. Genesight, for example, states on its web site that the FDA has not decided to oversee its tests, but meets or exceeds all industry quality standards and complies with federal law and has been approved by CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists). Also, Medicare and the Department of Veterans Affairs have approved its tests and even some private insurance will cover them.

Genesight result reports are sent to the physician but are fairly easy for the layman to understand, with drug names listed in categories, along with "red", "yellow", and "green" zones to indicate how well suited, based on the genetic assessment, the patient is for different categories of psychiatric drugs, pain drugs, or ADHD drugs. Because the report is drug specific, and provides information that goes beyond what might be related to drug metabolism markers in the genes, it is worth wondering if the FDA intends to look more closely at regulating the report claims of genetic testing labs like Genesight that it previously chose not to regulate.

Sources and more reading:

- Pharmacogenomic test now available to help guide clinicians' medication decisions for veterans being treated for behavioral health conditions (Genesight company press release, 2014)

- Sample pharmacogentic report for Psychotropic drugs, Genesight. Includes antidepressants, antianxiety drugs, antipsychotics, and mood stablizers. (No sample report was available for the newly approved 23andme OTC product.)

- NBC News Report: "New Psychiatric DNA Testing is Unproven Ground" October 4, 2015

- FDA Safety Communication: warning to consumers about genetic tests that claim to predict patients' responses to specific medications. November 1, 2018

- FDA News Release: FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism. October 31, 2018