The test is the first of its kind to secure FDA approval.
Officials with the US FDA this week permitted marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications better than others. The FDA authorization makes this the first test of its kind to secure this type of approval.
In a statement from the FDA, officials noted that the 23andMe Personal Genome Service Pharmacogenetic Reports test "is not intended to provide information on a patient’s ability to respond to any specific medication. 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. Furthermore, health care providers should not use the test to make any treatment decisions."
However, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said that the test's approval are" a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their health care providers.”
Pharmacogenetics is the process of understanding what, if any, role genetics plays in a patient’s reaction to drugs. The Personal Genome Service test analyzes DNA from a self-collected saliva sample, and the report describes if a person has variants in certain genes that may be associated with a patient’s ability to metabolize some medicines.
The FDA’s review of the test determined, among other things, that the company provided data to show that the test is accurate and replicatable.
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 this 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 6 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.