Beckman Coulter, a global clinical diagnostics leader, has announced that it was awarded funding by the Biomedical Advanced Research and Development Authority (BARDA) part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, for a multi-center clinical trial to validate the ability of its Monocyte Distribution Width (MDW) hematology biomarker to aid in the rapid detection of Multisystem Inflammatory Syndrome in Children (MIS-C). Recently defined by the Centers for Disease Control and Prevention (CDC), MIS-C is a rare but severe complication seen in children following SARS-CoV-2 infection.
The BARDA award will help fund a collaborative effort between Beckman Coulter and academic partners at Massachusetts General Hospital (MGH), Johns Hopkins University School of Medicine and the University of Florida to validate the effectiveness of the biomarker to detect MIS-C with a large, multi-center clinical trial 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. An abnormal MDW could potentially aid in triaging patients for care, starting treatment early and determining patient disposition.
“Primary care doctors and emergency department physicians need a rapid, reliable diagnostic test for MIS-C to accurately identify children early in the illness,” said Lael Yonker, M.D., pediatric pulmonologist at MGH, assistant professor at Harvard Medical School and one of the lead researchers on the study. “Fevers are very common in kids, but most are caused by self-limiting infections or they resolve with antibiotics. MIS-C also presents with fever, but it can progress to a severe, life-threatening illness.”
Initially reported as hyperinflammatory shock and “Kawasaki-like” illness, MIS-C has been observed to have overlapping features with toxic shock syndrome, atypical Kawasaki disease, macrophage activation syndrome, and cardiogenic and septic shock. Although most MIS-C patients survive with adequate intensive care, deaths have been reported. The long-term consequences of MIS-C are currently unknown.
“Identifying MIS-C is challenging because the primary symptom is one of the most common symptoms prompting pediatric evaluation in children of all ages,” said Shamiram R. Feinglass, M.D., M.P.H., chief medical officer, Beckman Coulter. “Given the community spread of COVID-19, empowering clinicians with a tool to aid in the early detection of MIS-C is critical because, undetected, MIS-C can result in the rapid onset of hypotensive shock, cardiac aneurysm or ventricular failure. The MDW biomarker is unique because it is available as part of a routine complete blood cell count. Having this specific data so early in the encounter enables physicians to act fast when every moment matters.”
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. Considered with other signs and symptoms, the value of MDW helps differentiate sepsis from non-septic presentations, including non-infectious, systemic inflammatory response.
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