NEW YORK ─ Beckman Coulter said on Thursday that it was awarded funding by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) for a multicenter clinical trial to validate its monocyte distribution width (MDW) hematology biomarker for the rapid detection of multisystem inflammatory syndrome in children (MIS-C).
MIS-C is a rare but severe complication recently defined by the US Centers for Disease Control and Prevention and seen in children following SARS-CoV-2 infection.
The BARDA award will help fund a collaborative effort between Brea, California-based Beckman Coulter and academic partners at Massachusetts General Hospital, Johns Hopkins University School of Medicine, and the University of Florida to validate the effectiveness of the biomarker to detect MIS-C in a large, multicenter clinical trial designed to support regulatory submissions.
Preliminary results from a study initiated at MGH earlier this year revealed that MDW has the potential to aid in the rapid detection of MIS-C, Beckman Coulter, a Danaher business, said. An abnormal MDW could potentially aid in triaging patients for care, starting treatment early and determining patient disposition, it added.
Beckman Coulter's MDW biomarker is a measure of increased morphological variability of monocytes, which can biologically indicate the presence of a systemic infection. The quantitative analysis of MDW has received regulatory clearances as an aid for early detection in adult patients with or developing sepsis in emergency departments.
In May, Beckman Coulter said that it was awarded almost $2.3 million by BARDA to advance R&D to optimize a machine learning-based sepsis diagnostic and a prediction algorithm to include assessment of its use with COVID-19 patients.