Genetic testing company 23andMe is facing a class action lawsuit alleging that the Silicon Valley start-up misled customers with advertising for its personalized DNA test kit.
The test was marketed as a tool to help users predict their risk of developing various diseases.
The lawsuit was filed in U.S. district court of California last week. It came days after the Food and Drug Administration ordered 23andMe to halt sales of its personalized test, saying the company has failed to show that the technology is supported by science.
(Read more: 23andMe chief strikes back after FDA warning)
23andMe sells its $99 test online. Customers receive a small tube in the mail, which they return to the company with a saliva sample for DNA analysis. The company claims the analysis provides insight into users' ancestry and future health risks, including 240 conditions and diseases.
The lawsuit by San Diego resident Lisa Casey alleges that the test results are "meaningless," and that 23andMe uses false and misleading advertising to promote its services to U.S. consumers. The lawsuit seeks at least $5 million under various California state laws and estimates "tens or hundreds of thousands" of U.S. customers are entitled to damages from the company.
Elsewhere, the complaint notes that 23andMe compiles customers' genetic information which it then markets to scientists for research. 23andMe has acknowledged that it hopes to pool the information from millions of customers to eventually create databases that can be mined for medical research.
"It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database," said Mark Ankcorn, a San Diego attorney who filed the lawsuit on behalf of Casey. Ankcorn said he was contacted Monday by an attorney representing 23andMe.
"I anticipate they are going to fight it and use every available resource they have to deny the claims," Ankcorn said.
(Read more: FDA identifies the idiot gene: 23andMe users)
A spokeswoman for Mountain View, Calif.-based 23andMe said in a statement Tuesday that it would not comment on legal matters. The company said it stopped advertisements via TV, radio and online last week. But the company's test kit is still prominently displayed on its website. When asked if the product is still being sold the spokeswoman declined to provide further comment.
The FDA's warning letter, dated Nov. 22, says the company's marketing materials violate federal law by making medical claims which have never been federally approved. FDA regulators have been warning the company since 2010 that its test is considered a medical product and is subject to federal review. 23andMe began selling the test in 2007. FDA's letter gives the company 15 days to respond in writing with steps to correct the violation.
23andMe was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.