The FDA authorized 23andMe to market its pharmacogenetic report Oct. 31, marking the agency's first time greenlighting a direct-to-consumer DNA test for this purpose.
Pharmacogenetics is an area of study dedicated to understanding the role a patient's genetics plays in their response to different drugs. 23andMe's new test, the Personal Genome Service Pharmacogenetic Reports, analyzes DNA from a customer's saliva sample to assess whether a person has one of 33 genetic variants that may be associated with their ability to metabolize some medications, such as clopidogrel, a drug used to prevent heart attacks and strokes.
The FDA reviewed 23andMe's test under its de novo premarket review pathway, which is targeted toward "novel" low- to moderate-risk medical devices, the agency noted. Before greenlighting the pharmacogenetic reports, the FDA reviewed data provided by 23andMe on users' comprehension of test results and on the test's ability to deliver accurate results.
"Pharmacogenetic reports are an important category of information for consumers to get access to and I believe this authorization opens the door for consumers to work with their health providers to better manage their medications," said 23andMe co-founder and CEO Anne Wojcicki.
The FDA highlighted the service is "not intended to provide information on a patient's ability to respond to any specific medication" — in fact, it is only OK'd to help inform patients' discussions with healthcare providers, and the agency noted results from the test should be confirmed with an independent clinical pharmacogenetic testing service before using its findings to make medical decisions.
"The test does not describe an association between the detected variants and any specific drug nor whether a person will or will not respond to a particular drug," the FDA said. "Furthermore, healthcare providers should not use the test to make any treatment decisions."
To ensure customers understand the intended purpose of the product, the FDA established six criteria under which 23andMe must market its pharmacogenetic reports, including requiring the company label its tests with a warning that consumers should not use its results to stop or change any medications.
Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, emphasized that while the test represents a landmark for genetic testing, it "does not determine whether a medication is appropriate for a patient, does not provide medical advice and does not diagnose any health conditions."
"We know that consumers are increasingly interested in genetic information to help make decisions about their healthcare," he said. "This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their healthcare providers."