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

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.
 
The test, which measures procalcitonin, a biomarker for bacterial infections, is to be administered on a patient’s first day of admittance into the intensive care unit and takes around 20 minutes to produce results, BioMérieux said.
 
“As the progression of severe bacterial infections is affected by how early the patient receives appropriate treatment, measuring PCT levels is valuable in ICUs where sepsis represents a major health challenge,” the company said in a statement.

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