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.