Technology Info Crunch

by  Karla Lant  Dr. Gopal Murti/Science Photo Library/Getty Direct-To-Consumer 2.0 On April 6, the U.S. Food and Drug Administration (FDA) changed course on genetic testing kits from 23andMe, indicating that the company can now directly tell consumers when their DNA puts them at a higher risk for 10 different diseases. The current 23andMe risk profile includes Alzheimer’s, alpha-1 antitrypsin deficiency, hereditary thrombophilia, Parkinson’s, and Gaucher’s. The FDA’s turnaround is a gentler version of its original decision from 2013, which prevented the company from sharing these risks based on concerns they could be risky for consumers. The Director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren,  cautioned consumers in a statement , echoing the concerns that led to the previous ban on direct sales: “But it is important that people understand that genetic risk is just one piece of the bigger puzzle. It does no...

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...