FDA Orders 23andMe to Stop Selling DNA Analysis Tests
Google backed 23andMe, which is a private company that offers rapid genetic testing, has been ordered to halt all of their services by the U.S. Food and Drug Administration (FDA). According to the FDA, the company did not provide enough evidence that their analyses and tests were accurate. If the tests are not accurate, the FDA fears that people will receive false positives, which could influence them to make risky health decisions that could be unnecessary. 23andMe has to wait for clearance from the agency before it can serve any more of its customers.
"FDA is concerned about the public health consequences of inaccurate results from the P.G.S (Personal Genome Service) device," the FDA wrote in its warning letter, which was posted on the agency's website.
23andMe is one of the most popular genome testing companies and it has provided its services to nearly half a million people. Anne Wojcicki, who is the wife of Google founder, Sergey Brin, runs the company. The couple has been separated. The test, which can be purchased through the website, costs $99. It works by analyzing DNA from saliva samples. The company states that the P.G.S can offer information on over 240 genetic conditions and traits and inform people of their risks to certain diseases, such as breast cancer and heart disease.
"Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the P.G.S. for its intended uses, which have expanded from the uses that the firm identified in its submissions," the FDA reported according to the New York Times. "Instead, we have become aware that you [23andMe] have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the P.G.S.'s uses and consumer base without obtaining marketing authorization from F.D.A."
The FDA stated that the P.G.S. is a device that needs approval from the agency. 23andMe has responded and stated that the relationship with the FDA is important to the company and that the company will do what they can to meet the FDA's expectations. 23andMe has 15 business days to respond.