Gene-Testing Firm Told To Stop Marketing Its Services

FDA has warned 23andMe that it is violating federal law by marketing its Saliva Collection Kit and Personal Genome Service without the agency’s approval. In a Nov. 22 letter, FDA stated that most of the intended uses for the kit, as advertised on the company’s website, are medical device uses and thus require premarket approval. A direct-to-consumer genetic testing firm, 23andMe markets its service as providing “health reports on 254 diseases and conditions,” including carrier status, health risks, and drug response, and as a first step in preventing diseases such as diabetes, coronary heart disease, and breast cancer. FDA is concerned about the false-positive and false-negative rates of the tests. The company must immediately stop marketing its kit and service or face the possibility of seizure, injunction, and civil money penalties.