FDA Grants Marketing Approval for First Direct-to-Consumer Genetic Tests
The FDA has issued marketing approval for the first direct-to-consumer genetic tests to assess inherited risks for 10 diseases.
The tests were approved through the de novo premarket review pathway.
The 23andMe Personal Genome Service Genetic Health Risk (GHR) tests identify risks for Parkinson’s disease, late-onset Alzheimer’s disease, Celiac disease, 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.
The tests isolate DNA from a saliva sample, and test for more than 500,000 genetic variants. The presence or absence of some of the variants is associated with an increased risk for developing any one of the 10 diseases.