BARDA and Beckman Coulter are working together to aid in the detection of Multisystem Inflammatory Syndrome in Children (MIS-C), a severe complication following SARS-CoV-2 infection. The partnership will fund a multi-center clinical trial to 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.
In the United States, more than 1,000 children have been diagnosed with MIS-C since the start of the COVID-19 pandemic. 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, 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.
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.
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.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
About Beckman Coulter:
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.