04/07/2017
FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions
For Immediate Release
April 6, 2017
Release
The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. 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, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., director of the 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 23andMe GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants. The presence or absence of some of these variants is associated with an increased risk for developing any one of the following 10 diseases or conditions:
Parkinson’s disease, a nervous system disorder impacting movement;
Late-onset Alzheimer’s disease, a progressive brain disorder that destroys memory and thinking skills;
Celiac disease, a disorder resulting in the inability to digest gluten;
Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease;
Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements;
Factor XI deficiency, a blood clotting disorder;
Gaucher disease type 1, an organ and tissue disorder;
Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition;
Hereditary hemochromatosis, an iron overload disorder; and
Hereditary thrombophilia, a blood clot disorder.