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23andMe hit with lawsuit over 'meaningless' gene tests

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A class-action lawsuit claims 23andMe misled customers over its $99 genetic test.--Courtesy of 23andMe

Amid scorn and scrutiny from the FDA, 23andMe is facing a class-action lawsuit claiming the company misled customers by selling genetic tests with no real scientific value, and plaintiffs want at least $5 million in damages.

In a California lawsuit filed last week, Personal Genome Service (PGS) customer Lisa Casey said that 23andMe billed its test as a resource for verifiable information like drug response, carrier status and health risks, marketing claims she argues are false and misleading because they came without the FDA's sign-off. The lawsuit also calls into question 23andMe's stated goal of amassing users' genetic data, saying the company intends to market that information to third parties "even though the test results are meaningless."

Casey invites all of 23andMe's customers, assumed to be in the hundreds of thousands, to join the suit, seeking $99 in damages for each in what amounts to a refund for PGS.

The lawsuit came just days after the FDA fired off a sternly worded warning letter chiding 23andMe for its deadbeat regulatory strategy and demanding PGS be taken off the market. This week, the company confirmed that it had pulled all of its TV, web and radio ads, but, as of Tuesday evening, would-be customers can still order the test on 23andMe.com.

23andMe isn't commenting on the lawsuit and, outside of a fairly vague blog post by CEO Anne Wojcicki, has remained tight-lipped about the FDA issue. That said, the company has essentially spelled out its counterargument elsewhere: 23andMe maintains that PGS is not a diagnostic service but is instead "intended for research and educational purposes only," a distinction that would theoretically exempt the test from the rigors usually required of legally defined medical devices.

The FDA, of course, disagrees, arguing in its letter that PGS's listed uses dovetail perfectly with its definition of a diagnostic device, thus requiring clinical validation before marketing. The agency worries that unverified PGS results could motivate patients to take drastic measures like undergo elective surgery or alter their drug regimens, and, after years of sporadic contact with 23andMe, the FDA has apparently run out of patience in demanding that the tests come off the market.

For its part, 23andMe stands by the accuracy of the data it returns to customers, and while Wojcicki acknowledges that the company is "behind schedule" with its FDA submissions, she has seemed to suggest a compromise with the agency in regulating the "new industry" of personal genetic testing.

- check out the lawsuit (PDF)

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