Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service

The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect 33 variants for multiple genes associated with a patient’s ability to metabolize certain medications to help inform discussions with a healthcare provider. The announcement was made Oct. 31.

About the Test
Pharmacogenetics is the process of understanding what role, if any, genetics plays in a patient’s reaction to drugs. The Personal Genome Service test analyzes DNA from a self-collected saliva sample and generates a report describing if a person has variants in certain genes that may be associated with a patient’s ability to metabolize some medicines.

The 23andMe Personal Genome Service Pharmacogenetic Reports test isn’t intended to provide information on a patient’s ability to respond to any specific medication. The test doesn’t describe an association between the detected variants and any specific drug nor whether a person will or will not respond to a particular drug. Furthermore, healthcare providers shouldn’t use the test to make any treatment decisions. Results from this test should be confirmed with independent pharmacogenetic testing before making any medical decisions.

The FDA’s Reasoning
“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussion with the healthcare providers,” noted Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We know that consumers are increasingly interested in genetic information to help make decisions about their health care.”

At the same time, Stenzel expressed caution regarding the test’s use. “This test should be used appropriately because it does not determine whether a medication is appropriate for a patient, does not provide medical advice, and does not diagnose any health conditions. Consumers should not use this test to make treatment decisions on their own,” he said. “Any medical decisions should be made only after discussing the results with a licensed health care provider and results have been confirmed using clinical pharmacogenetic testing.”

The Review Process
The FDA’s review of the test determined, among other things, that the company provided data to show that the test is accurate (i.e., can correctly identify the genetic variants in saliva samples) and that it can provide reproducible results. The company submitted data on user comprehension studies that demonstrated that the test instructions and reports were understood by consumers. The test report provides information describing what the results might mean, what the test does not do, and how to interpret results.

The Special Controls
The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. Along with its authorization, the FDA is establishing criteria, called special controls, which set forth the agency’s expectations in assuring the test’s accuracy, clinical performance, and labeling. For this category of device, the FDA established six special controls, including a labeling requirement that a warning statement must be included noting that the consumer should not use the test results to stop or change any medication. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test.