FDA Approves 23andMe’s $199 Genetic Tests for Risk of Late-onset Alzheimer’s Disease

Americans who want to assess their risk for late-onset Alzheimer’s disease may now order $199 genetic tests, now that the U.S. Food and Drug Administration (FDA) has allowed 23andMe to sell such genetic analyses directly to consumers.

Besides Alzheimer’s, the Mountain View, Calif., company has received authorization for reports on Parkinson’s disease, hereditary thrombophilia, celiac disease and five other illnesses.

“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” Anne Wojcicki, 23andMe’s CEO and co-founder, said in a press release. “The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics.”

The tests provided by 23andMe, which bills itself as a “personal genetics company,” offer information about genetic mutations and DNA variations that have been shown to increase the risk of disease risk. For late-onset Alzheimer’s, this simply means a test for the presence of the e4 variant of the APOE gene. The company underscored that it does not describe a person’s overall risk to develop the condition.

Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, cautioned against over-interpreting test results.

“Consumers can now have direct access to certain genetic risk information,” Shuren said in a statement issued April 6. “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.”

According to STAT, the FDA’s approval of genetic tests for late-onset Alzheimer’s has caused concern among researchers and physicians, who warn that the relationship between Alzheimer’s  and the APOE gene is “complex and not fully understood.” In fact, Alzheimer’s expert Rudolph Tanzi of Harvard Medical School said such tests should be accompanied by genetic counseling.

But in a New York Times article about the approval, Harvard genetics professor Robert Green, MD, said people requesting personal genetic information can handle such risk reports well.

The Alzheimer’s Association underscores that health professionals do not recommend genetic tests for APOE. The association’s British counterpart, the Alzheimer’s Society, goes further, warning that APOE tests have a low predictive value. “Someone who has two copies of the higher risk APOE variant e4 is not certain to develop Alzheimer’s disease, while someone who has other variants still might,” according to the society, which notes that U.K. insurance companies are banned from using genetic information until November 2019.

This view is corroborated by research showing that a host of environmental, modifiable factors contribute to Alzheimer’s risk. On the consumer side, the test procedure itself is as simple as spitting in a test tube and sending it to 23andMe by mail.

The test, which becomes available this month, was made possible by a new FDA permit type, including what the agency called “special controls” to assure the accuracy of tests. The FDA also indicated that it will create an exemption that allows 23andMe to release additional tests without further regulatory procedures.