Nov. 25, 2013—Late last week the U.S. Food and Drug Administration sent a letter ordering a halt to the marketing of the 23andMe Saliva Collection Kit and Personal Genome Service. The Mountainview, Calif.-based private firm 23andMe Inc. offers the mail-order kit to consumers for $99 and in August launched a $5 million national TV advertising campaign for the service.
In a Nov. 22 warning letter to company CEO Ann Wojcicki, the agency said it considers the product a class 3 medical device subject to agency regulation because “it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.”
Some of the uses for the testing kit are “particularly concerning,” Alberto Gutierrez, director, FDA Office of In vitro Diagnostics and Radiological Health, stated in the letter. That is because of serious consequences that could result from false negative or false positive results, Gutierrez’s letter said.
He added that the agency has worked with 23andMe Inc. but has not yet received assurance that its testing kit has been analytically or clinically validated. The FDA said the company “must immediately discontinue marketing” the kit, and not resume until it has received the agency’s authorization to market the device.