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BioMérieux Gets Expanded FDA Approval for Sepsis Assay

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.

The test was originally approved for use in patients in the first day following admission to an intensive care unit. Now, it is cleared for monitoring PCT levels over 96 hours to help physicians make treatment decisions for high-risk sepsis patients.

BioMérieux said that as part of a filing for the expanded approval, it provided the FDA with equivalence data of Thermo Fisher Scientific’s Procalcitonin Monitoring Sepsis Study — or MOSES — which tracked PCT levels of patients with severe sepsis or septic shock. Patients whose PCT levels decreased by 80 percent or more during the 96 hour timeframe of the study had a significantly lower risk of 28-day mortality compared to those whose PCT measurements decreased less than 80 percent over 96 hours, the company said. 

"The study demonstrates that for patients diagnosed with sepsis or septic shock, failure of blood concentrations of PCT to decrease over 96 hours is a strong predictor of mortality over and above clinical indicators," BioMérieux CMO Mark Miller said in a statement. "Measuring PCT at clinical presentation and serially over four days will provide clinicians with high medical value information to help them identify patients who are at greatest risk of mortality and ultimately can result in improved, more targeted, and intensified patient care and better medical outcomes."