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The FDA has approved a directto- consumer test that assesses genetic variations that may affect a person’s ability to metabolize certain drugs. The manufacturer, 23andMe, has reported that the test can detect 33 variants for multiple genes, which may affect more than 50 commonly prescribed medications and OTC products. A self-collected saliva sample is analyzed to determine how a patient’s genes may impact the metabolism of certain drugs – mainly whether he or she is likely to be a fast or slow metabolizer. It does not provide details about how genetic variants affect a patient’s response to a particular drug, or determine whether a patient should be taking a certain drug. The FDA cautions healthcare providers not to use the test to make treatment decisions; the results should be confirmed with independent pharmacogenetic testing.

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

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