In the United States, more than 1,000 children have been diagnosed with Multisystem Inflammatory Syndrome in Children (MIS-C), a severe complication following SARS-CoV-2 infection, since the start of the COVID-19 pandemic.
MIS-C diagnosis is difficult as the initial symptoms, such as fever or rash, are mild and variable. There are currently no cleared MIS-C diagnostics available.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) this week announced a federal partnership with Beckman Coulter to fund a multi-center clinical trial to advance MIS-C diagnostic capabilities. The partnership will validate the ability of Beckman Coulter’s FDA-cleared Monocyte Distribution Width (MDW) hematology biomarker, indicated to aid in the detection of adult sepsis, to identify MIS-C in children as well.
MDW is a FDA-cleared marker of sepsis for adults and used in emergency departments. Preliminary results from a study initiated at Massachusetts General Hospital revealed that the MDW hematology-based biomarker has the potential to aid in the rapid detection of MIS-C.
This collaborative effort between Beckman Coulter and academic partners at Massachusetts General Hospital, Johns Hopkins University School of Medicine and the University of Florida will seek to validate the effectiveness of the technology with a large, multi-center trial to support regulatory approval.
MIS-C is a rare but serious post-COVID-19 condition. Left untreated, the condition leads to serious, life-threatening complications, including hypotensive shock, cardiac aneurysm, or ventricular failure. The long-term implications are unknown. However, despite the severity,
With widespread SARS-CoV-2 infections among children, which may increase as more schools resume in-person classes or move to hybrid models, there is an immediate need for methods to rapidly detect this severe complication. Early detection can help improve patient outcomes by prompting early treatment and appropriate clinical management.
