The U.S. Food and Drug Administration (FDA) recently cleared DNA-testing company 23andMe to begin marketing the first ever direct-to-consumer pharmacogenetic test. Pharmacogenetic tests evaluate an individual’s potential response to a particular drug therapy, and are sometimes used to help predict the development of genetic diseases.
With the clearance, 23andMe will now be able to advertise its Personal Genome Service Pharmacogenetic Reports to consumers, which identify 33 different variants among eight genes in order to try and predict a person’s ability to metabolize medications. Specifically, 23andMe may now use this information to tell consumers whether they are likely to be fast or slow metabolizers of medications. While one of the goals of such testing is to prevent potential adverse drug effects, some clinical professionals have stated that such can already be done by starting with low dosages and slowly increasing them, as needed.
23andMe, Inc. operates as a personal genetics company that provides DNA analysis services. The company offers information and tools for individuals to learn about and explore their DNA. The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, dietary supplements, medications, vaccines, biopharmaceuticals, medical devices, and other products.
This was reported by Psychiatric News on December 18, 2018.
Contact Information: U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993; (888) 463-6332; Website: www.fda.gov
Contact Information: 23andMe, Inc., 899 West Evelyn Avenue, Mountain View, California 94041; (650) 938-6300; Website: www.23andme.com