FDA approves sale of genetic tests for risk of Alzheimer’s and other diseases
HEALTH Third Party Content:STAT By MEGHANA KESHAVAN @megkesh APRIL 6, 201 C onsumers will soon be able to mail a saliva sample to genetic testing company and get back data on their risk for developing diseases such as Parkinson’s, late-onset Alzheimer’s, and celiac disease. The Food and Drug Administration on Thursday granted approval to genetic testing company 23andMe to offer such direct-to-consumer tests for 10 conditions. But Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, urged customers not to take their test results as a sure sign that they will — or will not — develop a particular disease. It’s “important that people understand that genetic risk is just one piece of the bigger puzzle,” Shuren said in a statement . The FDA’s approval does not extend to diagnostic tests, such as genetic analysis that help determine a woman’s risk for breast cancer and that could lead to treatment decisions such...