23andMe face class action suit
Los Angeles | 04 December 2013

23andMe has been named in a class action suit after receiving a Food and Drug Administration (FDA) warning letter over its personal genome service (PGS) testing service.

Lisa Casey brought the class action against 23andMe at the US District Court for the Southern District of California on 27 November on behalf of hundreds of thousands women who have used the PGS tests.

The suit alleged that 23andMe falsely and misleadingly advertises its Saliva Collection Kit/PGS by stating that, among others, it provides health reports on more than 240 conditions and traits, despite the fact that "there is no analytic or clinical validation of the PGS for its advertised uses".

The suit quoted facts directly from the FDA public letter, issued on 22 November, that said 23andMe had not provided required data to it, despite increasing its marketing activity.

“You did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May,” stated Alberto Gutierrez, a director in the FDA’s Centre for Devices and Radiology, in the public letter.

The company, which sparked controversy when it patented technology that critics argued could pave the way for the creation of “designer babies”, has had to immediately discontinue selling its genetic tests after failing to provide information to back its marketing claims.

Plaintiffs demand a jury trial, punitive damages, costs of suit and pre- and post-judgment interest.

Author: Franki Webb

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