The American Journal of Bioethics, Volume 12, Issue 2, Page 22-24, February 2012.

While 23andMe aspires to be “the world's trusted source of personal genetic information,” the U.S. Food and Drug Administration (FDA) believes that the company's advertising practices have been anything but trustworthy. Last November, a harshly worded FDA “warning letter” demanded that the direct‐to‐consumer genetic testing company immediately discontinue marketing its unapproved “medical device.” The tussle between 23andMe and the FDA has attracted more attention than a typical disagreement between a company and a government agency. Larry Downes and Paul Nunes identify (...) 23andMe as a “Big Bang Disruption”: an invention that revolutionizes the existing market, foiling both industry incumbents and unprepared regulators. The outcome of the FDA's current review to hold the answer to the million‐dollar question: how will DTC genetic testing be regulated in the future? Ideally, the FDA's regulations should not pose undue burdens on consumers seeking personal genetic information but, rather, help consumers make a transition out of the consumer setting and into the medical setting. (shrink)

The American Journal of Bioethics, Volume 11, Issue 12, Page 27-29, December 2011.

The American Journal of Bioethics, Volume 12, Issue 9, Page 45-47, September 2012.