The DNA tests identify genetic risks for 10 diseases, including Parkinson’s, Alzheimer’s and rare blood diseases. The Ancestry and Health test — just one of several offerings —costs $199.
To conduct the test, customers send a saliva sample to 23andME, which then extracts the DNA from saliva cells and tests it for genetic markers. Six to eight weeks later, the company emails customers, alerting them their test results are available to access online.
The approval marks the first time the FDA has allowed a company to market genetic tests directly to consumers. Traditionally, patients need to visit a medical professional — and sometimes a genetic counselor — who order the test and later deliver the results, according to the report.
“Consumers can now have direct access to certain genetic risk information,” Jeffrey Shuren, MD, 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.”
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