FDA Clears 23andMe’s Consumer Genetic Test for Medication Risks

Yesterday, the FDA approved the first DNA test intended for marketing directly to the consumer, providing them with information of potential health risks they are genetically predisposed to. Created by 23andMe, the test will be available to users through convenient mail-in saliva samples that generate comprehensive genetic results. 23andMe stated in a press release that it is yet to determine an official release date or price for the test.

23andMe’s test receiving FDA approval marks the first test of its kind being granted such clearance. Other genetic tests are on the market; however, they all require active participation of a certified physician or psychiatrist. With this convenient test from 23andMe, customers can now see their genetic risk of several factors.

Their gene-testing kit includes screenings for several genes associated with Parkinson’s, breast cancer, and Alzheimer’s disease. The test also assesses which segments of DNA play strong roles in the metabolism of multiple medications, such as those for heart disease. Specifically, the test will provide insight on 33 genetic variants that 23andMe states are associated with how patients react to over 50 prescription and over-the-counter medications commonly used in practice.

The approval for marketing of 23andMe came with several caveats. The FDA cautioned consumers that the test is not a definitive measure of whether or not patients should be taking a specific medication. Rather, the system is designed to provide potential indication of predisposed risks associated with medications. The FDA states that patients should consult with their health care providers about results before generating a concrete interpretation.

Anne Wojcicki, CEO and founder of 23andMe, noted that the approved test is missing assessment for depression medications, also known as pharmacogenomics. She notes that the company is striving to bring back tests for these medications.

“The only one we don’t have back yet is pharmacogenomics. We used to have that and we’d like to have that one come back,” Wojcicki said on Tuesday at a panel discussion at the Rock Health Summit in San Francisco. The available test, however, does include assessments for Parkinson’s and Alzheimer’s diseases.

23andMe was created in 2006, with their main goal being to help people access, understand and benefit from their genetics. The company has over five million genotyped customers around the world, and provides ancestry services in addition to their health-centered genotyping.

Sources: StatNews, BusinessInsider, 23andMe