The U.S. Food and Drug Administration (FDA) announced on Thursday that it will allow the marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests to give consumers information regarding their risk to certain diseases.
According to a press release from the FDA, the at-home genetic testing kits is the first direct-to-consumer (DTC) test that will be authorized by the FDA. 23andMe's GHR tests will provide consumers information regarding their risk of 10 diseases: Parkinson's disease, Alzheimer's disease, celiac disease, factor XI deficiency, alpha-1 antitrypsin deficiency, primay dystonia, Gaucher disease type 1, Glucose-6-Phosphate Dehydrogenase deficiency, hereditary hemochromatosis, and hereditary thrombophilia.
The test is not designed to diagnose the aforementioned diseases but only to assess the genetic risk to help individuals make lifestyle changes.
“Consumers can now have direct access to certain genetic risk information. 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," said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
The FDA decided to approve the marketing of 23andMe GHR tests after conducting tests via the de novo premarket review pathway. A new special controls criteria will also be established to assure the GHR test's accuracy and reliability.
“By establishing special controls and eventually, a premarket review exemption, the FDA can provide a streamlined, flexible approach for tests using similar technologies to enter the market while the agency continues to help ensure that they provide accurate and reproducible results," Shuren said.
NPR noted that in 2013, 23andMe received a warning letter from the FDA for marketing their GHR tests without getting proper consent from the organization. As a result, FDA halted the selling of 23andMe tests until they receive approval.
Anne Wojcicki, the CEO and co-founder of 23andMe, said in a press release that the FDA approval is an "important moment" for individuals who want to know their risk of acquiring health diseases.
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