FDA Allows Marketing of Tests that Provide Genetic Risk Information

23andMe tests for 10 diseases or conditions.

  • Apr 11, 2017

The FDA has announced it is allowing the marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. According to the agency's news release, these are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions.

"Consumers can now have direct access to certain genetic risk information," said Dr. Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won't ultimately develop a disease."

The tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants. They can test for the following diseases: Parkinson's, Late-onset Alzheimer's, Celiac, Alpha-1 antitrypsin deficiency, Early-onset primary dystonia, Factor XI deficiency, Gaucher disease type 1, Glucose-6-Phosphate Dehydrogenase deficiency, Hereditary Hemochromatosis,  and Hereditary thrombophilia.

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