31 October 2018 - Today, the U.S. FDA 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 metabolise some medications to help inform discussions with a health care provider. 

The FDA is authorising the test to detect 33 variants for multiple genes.

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 labelling. For this category of device, the FDA established eight 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.

Read FDA press release