A lawsuit seeking class action status claims Silicon Valley startup 23andMe misled the public with advertising for its personalized DNA test kit and built up a
DNA database to sell to third parties, according to The Associated Press.
San Diego resident Lisa Casey filed the lawsuit last week, alleging that 23andMe tricked her with false and misleading advertisements. The U.S. Food and Drug Administration last month ordered 23andMe to stop sales of its personalized DNA test.
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The FDA said that 23andMe failed to show that the kit's technology is backed by any kind of science.
23andMe claimed that its test, which sold for $99 online, provided its customers insight into users' ancestry and future health risks, including 240 conditions and diseases.
Casey said in her lawsuit, though, that the test results are "meaningless" and is seeking at least $5 million under various California state laws and estimates "tens or hundreds of thousands" of U.S. customers are also entitled to damages, according to The Associated Press.
"It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database," Mark Ankcorn, Casey's attorney, said. "I anticipate they are going to fight it and use every available resource they have to deny the claims."
The San Diego Union-Tribune reported that customers of 23andMe provide a sample of their saliva, and the company says it performed a partial genetic analysis on the saliva, looking for genes that could be involved in a wide range of health problems.
The FDA's warning letter to 23andMe from Nov. 22 said that the company's marketing materials violate federal law by making medical claims that have never been federally approved. The AP noted that FDA regulators told the company in 2010 that its test was considered a medical product and was subject to federal review.
"We have received the warning letter from the Food and Drug Administration," a statement on 23andMe's website said. "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."
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