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This article was published on February 20, 2015

    23andMe has passed a big regulatory hurdle to getting back on the market

    23andMe has passed a big regulatory hurdle to getting back on the market
    Owen Williams
    Story by

    Owen Williams

    Former TNW employee

    Owen was a reporter for TNW based in Amsterdam, now a full-time freelance writer and consultant helping technology companies make their word Owen was a reporter for TNW based in Amsterdam, now a full-time freelance writer and consultant helping technology companies make their words friendlier. In his spare time he codes, writes newsletters and cycles around the city.

    Back in 2013, the FDA asked 23andMe to stop selling DNA-testing kits as it was offering services that could cause customers to undergo inappropriate treatments due to results shown by the service.

    Today, 23andMe has cleared a big hurdle in getting its service back in the US; the FDA approved the company’s Bloom syndrome carrier status report.

    The approval means that 23andMe is allowed to market the genetic test directly to consumers and helps pave the way for other reports to be performed in the future.

    While the FDA approval only applies to this single report, it means that 23andMe could be on its way to getting other genetic health reports approved by the government.

    ➤ A Note to Our Customers Regarding the FDA [23andMe Blog]