External double-blind prospective validation
We recently completed a decade long journey that included screening of >20,000 biomarkers, signature construction and initial validation ( PLoS, Oved et al. 2015), followed by a series of external validation studies, making MeMed BV the first blood test to accurately distinguish bacterial from viral infection that is validated in a double-blind manner. External double-blind validation studies included PathFinder (Pediatrics, Srugo et al. 2017), and the Opportunity Study (Lancet ID, Van Houten et al. 2016). Taken together the diagnostic performance of MeMed BV™ is 91% sensitivity, 94% specificity, with a negative predictive value of 96%.
"This study potentially moves us substantially closer to that Holy Grail of accurately
determining which child truly is at risk for having a serious bacterial infection"
Additional studies enrolling thousands of patients are underway to further interrogate various aspects of MeMed BV, assess its effectiveness in different populations and clinical settings, and develop additional immune-based tests.