FDA Clears BioMerieux's Sepsis-Risk Dx as an IVD

Oct 18, 2007

NEW YORK (GenomeWeb News) — BioMérieux said today the US Food and Drug Administration has cleared its in vitro diagnostic that tests for a patient’s risk of developing severe sepsis and septic shock.

The company said its VIDAS B.R.A.H.M.S. PCT assay is designed to help assess the risk that a critically ill patient with a bacterial infection faces of developing severe sepsis or septic shock.

BioMérieux launched the assay in Europe earlier this year.

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