LDT Regulation Update

FDA Official Outlines Need for Federal Regulation of LDTs

Harvard Medical School pathologist questions the idea that all LDTs put patients at risk of harm

AT A CONGRESSIONAL BRIEFING LAST WEEK, a federal official charged with regulating laboratory-developed tests made the case that LDTs are inconsistently reliable and thus put patients at risk, according to MedPage Today. “If you take the same patient sample and you send it to different labs, you can get different results,” stated Jeff Shuren, MD. He […]

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FDA Official Outlines Need for Federal Regulation of LDTs

Harvard Medical School pathologist questions the idea that all LDTs put patients at risk of harm

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