The United States Food and Drug Administration (FDA) approved on Wednesday the first direct-to-consumer test for detecting genetic variants that might be associated with a patient's ability to cope with some medications.
"This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their health care providers," said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.
FDA authorized the test to detect 33 variants for multiple genes, identifying what role genetics play in a patient's reaction to drugs.
The "Personal Genome Service" test will analyze DNA from a self-collected saliva sample and report if a person has variants in certain genes that may be associated with a patient's ability to metabolize some medicines.
However, the test is not intended to provide information on a patient's ability to respond to any specific medication, and health care providers should not use the test to make any treatment decisions, according to FDA.
FDA granted the marketing authorization to 23andme, a California-based personal genomics and biotechnology company.
