Discovery and Clinical Validation of Host Biomarkers of Disease Severity and Multi-system Inflammatory Syndrome in Children (MIS-C) and COVID-19

SARS-CoV-2 infection exhibits a wide range of clinical outcomes in both children and adults, from asymptomatic and mild disease to severe viral pneumonia, ARDS, acute kidney injury, thrombotic disorders, and serious cardiac, cerebrovascular and vascular complications. It is now known that severe infection can occur both in young children and young adults (<21) and that nearly 40% of those who are admitted Covid-19 require ICU support, including mechanical ventilation. One of the most severe manifestations of SARS-CoV-2 infection is the multisystem inflammatory syndrome in children (MIS-C), a serious condition associated with severe inflammation with multi-organ involvement that can result in a variety of clinical presentations including pneumonia, sepsis, coagulation abnormalities, and renal/kidney failure. Thus, novel approaches for early and accurate diagnosis of COVID-19 associated syndromes and evaluation of clinical severity and outcomes of COVID-19 disease in children were urgently needed. This study identified RNA transcriptomic and cell-free DNA omics biomarkers that were used to develop and validate host-based assays from nasal swab and blood samples, with the goal of regulatory submission for FDA Emergency Use Authorization (EUA).