The U.S. Food and Drug Administration (FDA) has approved a direct-to-consumer genetic test to provide information about a person’s ability to metabolize certain medications based on their genetic make-up. This FDA-approval is for the 23andMe Personal Genome Service Pharmacogenetic Reports, which tests for 33 genetic variants for multiple genes and could help patients and their health care providers make better medication decisions.
This test uses pharmacogenetics — the process of understanding the role genetics play in a person’s reaction to drugs, if any. It uses a saliva sample, which is typical for other types of genetic tests as well.
According to the FDA, this test isn’t intended to provide information about whether a patient will or will not respond to a particular drug, and it shouldn’t be used to make treatment decisions. Results should be confirmed by additional testing. Approval includes six special controls, including a label warning that consumers should not use test results to stop or change their medication.
Sourced from: FDA