Direct-to-Consumer Genomics in the Crosshairs

Personal genomics seemed to be on a rocketship trajectory until the FDA sent a warning letter to 23andMe questioning marketing materials that bordered on self diagnosis.

The experience is simultaneously unsettling, illuminating, and empowering,” gushed Wired magazine in a 2007 article heralding the unveiling of 23andMe’s new direct-to-consumer genetic test, and with it “the birth of a new personalized medicine industry.” “The exploration of the human genome has long been relegated to elite scientists in research laboratories,” proclaimed the New York Times. “That is about to change.”

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