BARDA taps Beckman Coulter to develop a blood test for MIS-C, the severe childhood illness linked to COVID-19

While most children may only show mild symptoms after exposure to the novel coronavirus, some develop severe, life-threatening complications that can attack several organs at once. Known as Multisystem Inflammatory Syndrome in Children, or MIS-C, it can affect the heart, lungs, kidneys, brain, skin and eyes.

But there's an obstacle before they can receive effective treatment: the disease's earliest signs include fever and a rash—symptoms shared with many common childhood illnesses or colds. 

To help tell the difference, Beckman Coulter has been awarded a contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a rapid diagnostic test for children with COVID-19.

The company is working to establish a blood-based biomarker for detecting signs of the pediatric disease, based on a test used to spot early cases of sepsis in adults. The diagnostic will measure monocyte distribution width, or variations in the size of certain white blood cells in the bloodstream, which can be a sign of a systemic infection.

The BARDA funding, of a currently undisclosed amount, will help support a clinical trial run by Beckman Coulter and academic researchers at Massachusetts General Hospital, Johns Hopkins University School of Medicine and the University of Florida, with the goal of putting the test up for future regulatory approvals. 

“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 one of the study’s lead researchers, Lael Yonker, an assistant professor at Harvard Medical School and a pediatric pulmonologist at MGH, which conducted a preliminary study in monocyte distribution width earlier this year.

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“Fevers are very common in kids, but most are caused by self-limiting infections or they resolve with antibiotics,” Yonker added. “MIS-C also presents with fever, but it can progress to a severe, life-threatening illness.”

According to BARDA, more than 1,000 children have been diagnosed with MIS-C this year. During the earliest stages of the pandemic, MIS-C cases were initially identified as hyperinflammatory shock or an illness similar to Kawasaki disease, a syndrome that primarily affects young children and causes fevers, rash and inflammation. MIS-C’s signs, symptoms and progression have also overlapped with certain cases of toxic shock syndrome, as well as cardiogenic and septic shock.  

“Identifying MIS-C is challenging because the primary symptom is one of the most common symptoms prompting pediatric evaluation in children of all ages,” Beckman Coulter Chief Medical Officer Shamiram Feinglass, M.D., said. 

“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,” Feinglass said. “The MDW biomarker is unique because it is available as part of a routine complete blood cell count.”