FDA Approves Marketing Of Consumer Genetic Tests For Some Conditions
The U.S. Food and Drug Administration approved 23andMe's personal genetic test for some diseases on Thursday, including Alzheimer's, Parkinson's and celiac diseases.
The tests assess genetic risk for the conditions but don't diagnose them, the FDA says. The agency urges consumers to use their results to "help to make decisions about lifestyle choices or to inform discussions with a health care professional," according to a press release about the decision.
Jeffrey Shuren, the director of the FDA's Center for Devices and Radiological Health, wrote, "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." Other known factors that can play into the development of disease include diet, environment and tobacco use.
The FDA has previously scolded the company for marketing the personal genetic testing kits without the agency's consent. In 2013, the agency told 23andMe to stop selling its personal genome kits in the United States until they gained FDA approval by proving they were accurate.
The company agreed to work with the FDA, as we reported, and a recent FDA review of peer-reviewed studies found more consistent links between certain gene variants and 10 diseases, the FDA says. [...]biotechnology fda genetics regulation