23andMe gets FDA permission to tell customers about disease risks in their genes
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 healthcare professional.
23andMe Inc., based in Mountain View, Calif., 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 healthcare professionals. But it cautioned that genetic risk is just one piece of information and does not mean people will or won’t eventually get a disease.
23andMe has been closely watched because of its role as a pioneer in the personal genetic-testing space — and because its chief executive and co-founder, Anne Wojcicki, is the ex-wife of Google co-founder Sergey Brin.
Google is one of the companies that have provided venture capital to 23andMe.