23andMe, a personal genomics and biotechnology company, is now facing a class action lawsuit even as the company has confirmed that it has stopped marketing its DNA test kits.
The Google-backed 23andMe has been selling and marketing the gene testing kit since 2007. In 2010, the U.S. Food and Drug Administration (FDA) contacted 23andMe and a few more companies selling similar testing services that it considered subject to agency's oversight. Moreover, the FDA also said that it has worked with 23andMe in order to secure marketing authorization.
The recent lawsuit has been filed by San Diego-based Lisa Casey, a customer, who says that she has paid for the tests and also received her results. The lawsuit, which is seeking a minimum of $5 million, says that the company makes false and misleading claims about its testing services to provide relevant genetic information about medical conditions, such as diabetes, breast cancer, lactose intolerance and more.
FDA has also issued a warning letter to Anne Wojcicki, CEO and co-founder of 23andMe, and asked the company to pull down all its advertisement. In response to the FDA warning letter and the lawsuit filed by Casey, 23andMe is said to have stopped all advertisements on radio, television and online for its $99 personal genome service, which requires a consumer to send a saliva test to the laboratory to analyze genetic clues to ancestry and any risk for a list of diseases.
"Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions," states the letter issued by FDA to Wojcicki.
The FDA said that 23andMe has been unsuccessful in providing an adequate respond to its feedback on the company's 2012 application for regulatory approval. The company has not also provided scientific evidence to the FDA that the testing service works.
The regulatory agency also pointed out that it was concerned that 23andMe's imprecise test results may prompt people to undergo unnecessary health procedures.
23andMe said it will work with the FDA to resolve the problem. "In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses," the company said in a statement.
"We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns," it added.