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FDA orders 23andMe to halt sales of DNA test kit


The FDA has ordered to halt sales of its DNA analysis product, claiming that its currently being marketed without marketing clearance or approval from regulators. (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 morbidity-inducing actions. On the opposite end, a false negative could result in a failure to recognize an actual risk that may exist. Serious concerns are raised if test results are not adequately understood by patients… The idea of patients self managing any conditions they may have without a doctors input seems to be a major concern for the FDA.

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MONDAY, MARCH 27, 2023

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