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

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
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