The Food and Drug Administration (FDA) has approved the first-ever home DNA tests that let people find out their genetic risk for developing certain diseases.
The FDA said Thursday it will allow home DNA testing company 23andMe to market its genetic tests directly to consumers, giving people risk information for 10 diseases, including Alzheimer’s, Parkinson’s, celiac and several blood diseases.
“Consumers can now have direct access to certain genetic risk information,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
Genetics are not the only factor in determining whether a person will get a disease. An individual’s genes may also interact with lifestyle and environmental factors to lead to a disease. When it comes to diseases like Alzheimer’s, the National Institute on Aging says it is unlikely that genetic testing will ever be able to predict the disease with complete accuracy because so many factors influence its progression.
This is not 23andMe’s first foray into the world of genetic risk testing. The company used to offer tests for more than 200 conditions, but the FDA forced it to stop in 2013 for failing to show the tests were “analytically or clinically validated.” Then, in 2015, 23andMe got FDA approval for a home test for Bloom syndrome, a rare disorder that can raise a person’s risk of cancer.
Now that it has FDA approval for these new tests, 23andMe said it will release its first set of new genetic tests this month, with more to follow. The FDA’s decision is expected to be controversial given the company’s history, but it also opens the door to other home DNA tests in the near future.
“In addition, the FDA intends to exempt additional 23andMe GHR (genetic health risk) tests from the FDA’s premarket review, and GHR tests from other makers may be exempt after submitting their first premarket notification,” the FDA said in its statement. “A proposed exemption of this kind would allow other, similar tests to enter the market as quickly as possible and in the least burdensome way, after a one-time FDA review.”
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