FDA reversal gives 23andMe clearance to sell genetic tests direct to consumers
The U.S. Food and Drug Administration announced April 6 that it would allow 23andMe to market its Personal Genome Service Genetic Health Risk tests straight to consumers, which could help them make more informed decisions about their lifestyles and healthcare.
The tests are able to assess the likelihood of 10 different conditions, giving individuals tailored information about their risks for inherited diseases such as Parkinson's and Alzheimer's.
"Consumers can now have direct access to certain genetic risk information," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in a statement.
He warned, however, that it's "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."
For the FDA, it's a reversal. For 23andMe CEO and Co-Founder Anne Wojcicki it might be seen as vindication.
Back in 2013, the agency imposed a moratorium on disease tests sold by the Mountain View California-based 23andMe, essentially shutting it down.
The new decision is expected to open the floodgates for more direct-to-consumer tests for disease risks, paving the way for other companies to enter the market.
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.
The FDA reviewed data for the 23andMe GHR tests through a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
Shuren said the FDA is establishing "special controls," which clarify the agency's expectations in assuring the tests' accuracy, reliability and clinical relevance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for these and similar GHR tests.
"The special controls describe the testing that 23andMe conducted to demonstrate the performance of these tests and clarify agency expectations for developers of other GHRs," he said.