Life Sciences Blog

FDA orders halt to 23andMe genetic testing kit sales

Posted on November 26th, by Michael Shapiro-Barr

The FDA has ordered the genetic testing firm 23andMe to stop sales of its home-testing kit, which consists of a saliva test that customers send back to the company for reports on their heritage, receptiveness to medications and genetic risk for dozens of health conditions.  The FDA has stated that regulators do not have any assurance that the firm has analytically or clinically validated the personal genome service for its intended uses.

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Media Quotes

  • Mercedes Meyer, a patent lawyer with the firm Drinker Biddle in Washington, D.C., said the Supreme Court’s failure to provide “bright-line guidance”—a ruling that would settle once-and-for all whether patent settlements are legal or not—means there’s “really no difference now than what was going on.” Mercedes Meyer
    CNBC: High Court Allows FTC to Challenge 'Pay-to-Delay' Generics

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