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 FDA takes issue with "the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these." As one example, the FDA points out that a false positive for breast or ovarian cancer could "lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other...
via The Verge - All Posts http://www.theverge.com/2013/11/25/5143464/fda-orders-23andme-to-stop-selling-dna-test-kit
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