BioMérieux Gets Expanded FDA Approval for Sepsis Assay | GenomeWeb

NEW YORK (GenomeWeb) — BioMérieux today announced that it has received 510(k) clearance from the US Food and Drug Administration for the expanded use of its Vidas BRAHMS PCT assay for managing sepsis patients with elevated risk of mortality. 

The assay, which runs on BioMérieux's fully automated Vidas instrument, is designed to measure changes in blood levels of procalcitonin — a peptide precursor of calcitonin and a marker of inflammatory response — to differentiate bacterial infections from viral ones.

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