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23 and Me Runs into More Trouble

Scott Lucas | December 4, 2013 | Story Tech World

If it's not one thing it's another—Anne Wojcicki's terrible time continues. After the FDA warned home genetics testing company 23andMe that it did not have regulatory approval for its $99 home testing kit, the Mountain View company pulled its advertising on Monday. But that wasn't before the firm got hit with a class-action lawsuit.

The suit, filed in Southern California, alleges that the company "falsely and misleadingly" described their kit as providing "health reports, drug response, and carrier status," when, in fact, the results were what the suit calls "meaningless." Damages could run past $5 million.

Amid the moves, heated debate on the FDA's action continued: "Using the FDA’s logic, WebMD, and self-help books should be regulated too, because they dispensing advice that can potentially be misused by lay people," wrote Larry Popelka, comparing the firm to Uber and Airbnb. "The real issue is that the FDA—like virtually all government agencies—is predisposed to support the industry it regulates, so existing constituents in that industry are protected by it. As a result, innovative new businesses that challenge incumbents are penalized."

A story in Bloomberg shot back: "Individuals have a right to their own genetic information. [W]hether direct-to-consumer genetic test kits should be allowed despite their flaws misses a larger point. The problem with these test kits is scientific."

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