For the first time, U.S. regulators have authorized a company to tell consumers directly about their individual genetic risk of certain diseases and conditions without involving a health care professional.
The California-based company 23andMe gained approval from the Food and Drug Administration to market genetic testing for risk of 10 ailments, including Parkinson’s and Alzheimer’s diseases.
The FDA, which in 2013 blocked the company from providing genetic health information, announced its decision Thursday.
The agency said the new tests may help people make decisions about lifestyle and help them have informed discussions with health care professionals. But it cautioned that genetic risk is just one piece of information, and it does not mean they will eventually get a disease or not.
