In Turnaround, FDA To Allow Genetic Tests To Be Sold To Consumers
The decision to let 23andMe sell saliva-testing kits that report on markers for 10 diseases is expected to open the floodgates for more at-home tests for disease risks.
The New York Times:
F.D.A. Will Allow 23andMe To Sell Genetic Tests For Disease Risk To Consumers
For the first time, the Food and Drug Administration said it would allow a company to sell genetic tests for disease risk directly to consumers, providing people with information about the likelihood that they could develop various conditions, including Parkinson’s and Alzheimer’s. The move on Thursday is a turnaround for the agency, which had imposed a moratorium in 2013 on disease tests sold by the company, 23andMe, which is based in Mountain View, Calif. (Kolata, 4/6)
The Wall Street Journal:
FDA Approves 23andMe’s Genetic Test For Personal Disease Risks
The product is offered by the closely held Silicon Valley genetics-testing company 23andMe Inc., which was initially stymied by the FDA in 2013 when it sought to offer such saliva-analysis tests to the general public. But the company began making more headway by 2015, when it offered consumers a test to tell them if they carried a genetic variant for one of 36 diseases that could be inherited by their children. Those hereditary tests evaluated people for their likelihood of passing on conditions like cystic fibrosis, sickle cell anemia and a disease known as Bloom syndrome. (Burton, 4/6)