FDA says cancer detection kit is unproven, could harm public health

Bloomberg News reports that the Food and Drug Administration posted a warning letter cautioning that Pathway Genomics Corp’s liquid biopsy kit “is high-risk, could harm public health, and hasn’t been validated by science.” According to the FDA, the test is a medical device for which the company “hasn’t applied for regulatory clearance,” but the company maintains that the product “is a so-called laboratory-developed test that doesn’t require FDA clearance.”

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