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San Diego Woman Files Class Action Lawsuit Against Personal Gene-Testing Company

A San Diego woman who paid $99 to have her genes analyzed by 23andMe wants her money back. And she thinks thousands of other customers will too.

Aired 12/4/13 on KPBS News.

A San Diego woman who paid $99 to have her genes analyzed by 23andMe wants her money back. And she thinks thousands of other customers will too. Just days after the FDA ordered 23andMe to stop selling its products, the company now faces a class action lawsuit.

Just days after the Food and Drug Administration ordered 23andMe to stop advertising and selling its products, a San Diego resident named Lisa Casey filed a class action lawsuit against the company.

The FDA sought to test and approve 23andMe's "spit-kit" for use as a medical device, but the company ignored regulators' inquiries for months.

The Google-backed Silicon Valley company is known for its so-called "spit kits." Based on a saliva sample, 23andMe promises to provide a detailed genetic history report and genetic predispositions to certain conditions. But Casey is accusing 23andMe of false advertising, claiming its test results are "meaningless."

Casey's lawyer, Mark Ankcorn, says 23andMe's website misleads consumers into thinking the results should drive medical decisions.

"Some of the statements that were very concerning to us were, 'plan for the future,' 'find out if your children are at risk' for specific diseases," Ankcorn said. "That is making a claim about the medical usefulness or efficacy of the product."

Such claims need to be tested and approved by the FDA. But the FDA says 23andMe ignored its inquiries for months. Last week the FDA slapped the company with a cease and desist letter.

Ankcorn says it's fine for consumers to be curious about their genes, but he accuses 23andMe of taking advantage of their curiosity.

"People like my client are buying this kit because they want to know more about themselves," he said. "They want to know more about their family's risk for certain diseases. And that kind of information needs to be based on good science."

23andMe would not comment on legal matters. Ankcorn hopes to see everyone in the U.S. who purchased a 23andMe kit eligible to opt into the lawsuit. But approval for the class action is still months away.

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