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This article was published on November 25, 2013

    23andMe told to ‘immediately’ stop selling its DNA-testing kits until they are approved by the FDA

    23andMe told to ‘immediately’ stop selling its DNA-testing kits until they are approved by the FDA
    Nick Summers
    Story by

    Nick Summers

    Nick Summers is a technology journalist for The Next Web. He writes on all sorts of topics, although he has a passion for gadgets, apps and Nick Summers is a technology journalist for The Next Web. He writes on all sorts of topics, although he has a passion for gadgets, apps and video games in particular. You can reach him on Twitter, circle him on Google+ and connect with him on LinkedIn.

    23andMe has been told by the US Food and Drug Administration (FDA) to stop selling its DNA-testing kits and Personal Genome Service (PGS).

    The Google-backed startup has been selling its Saliva Collection Kit and DNA analysis service “without marketing clearance or approval” by the FDA, according to a letter sent out last Friday.

    23andMe has been selling its kits for over five years, but the FDA says it’s concerned that users could undergo unnecessary or inappropriate treatment due to a false positive or false negative reading. The startup now has fifteen days to take rectify the situation, or it could face regulatory action from the FDA.

    ➤ FDA letter (Via Bloomberg)

    Featured image credit: Shutterstock