The FDA has ordered 23andMe.com to halt sales of its DNA analysis product, claiming that it’s currently being marketed “without marketing clearance or approval” from regulators. By studying a sample of a user’s saliva, the company alerts customers about any diseases they currently carry or are at risk for. (23andMe says it can identify up to 254 diseases and other medical conditions.) The company has twice submitted its test kit for review as a medical device, but the FDA says it has largely failed to satisfy “the issues described during previous interactions” between both sides.
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