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cap and clia

Response to FDA’s Gottlieb on Reducing Regulatory Burden

IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …

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Medicare Contractor’s Ruling on MolDx Test Causes Lab to Close

CEO SUMMARY: On May 14, Predictive Biosciences learned that its Medicare contractor had determined that one of its three molecular tests for bladder cancer was a screening test. It also never got a determination on its other two molecular tests. Because Medicare is half of the lab’s pay…

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