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  • 23andMe, FDA and DNA health profiling

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    Are companies that provide direct-to-consumer information on their personal genome — including genetic susceptibility to disease — creating new health risks that need to be regulated?

    On November 22 2013, the US Food and Drug Administration requested that the personalized DNA analysis company 23andMe “immediately discontinue marketing the PGS [Personal Genome Service] until such time as it receives FDA marketing authorization for the device”.

    This week, Risk Bites looks at some of the questions raised by FDA’s response to 23andMe’s DNA Spit Test

    The Risk Bites Team:
    Producer: Andrew Maynard
    Research Director: David Faulkner

    Risk Bites is supported by:
    University of Michigan School of Public Health.
    University of Michigan Risk Science Center.

    Letter from FDA to 23andMe:
    David Dobbs: FDA Muzzles 23andMe After Talks Break Down
    Wall Street Journal:

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