"To date there are no methods that can quickly and accurately detect pathogens in blood to allow the diagnosis of systemic bloodstream infections that can lead to lifethreatening sepsis. The standard of care for detecting such bloodborne infections is blood culture but this takes days to complete only identifies pathogens in less than  of patients with fulminant infections and it is not able to detect toxic fragments of dead pathogens that also drive the exaggerated inflammatory reactions leading to sepsis.  Biomarkers that report elevated inflammation are used clinically in the treatment of patients with sepsis however they fail to distinguish inflammation triggered by infectious pathogens from that induced by noninfectious causes such as burns traumas and surgeries.  Now a Wyss Institute team led by Donald Ingber reports in eBioMedicine that it has filled this void with a rapid and specific diagnostic assay that could help physicians decide within an hour whether a patient has a systemic infection and should be hospitalized for aggressive intervention therapy. The potential of this assay to detect pathogen materials was demonstrated in both animal studies and a prospective human clinical study whose results also suggest that it also could serve as a companion diagnostic to monitor the success of antibiotic and dialysislike sepsis therapies.  Our pathogen detection technology solves both dilemmas it quickly reports whether infectious pathogens are present in the body even at early stages of infection before sepsis develops. And it can more specifically identify patients who have excessive inflammation due to systemic infection rather than other causes said Donald Ingber M.D. Ph.D. the Wyss Institutes Founding Director the Judah Folkman Professor of Vascular Biology at Harvard Medical School and the Vascular Biology Program at Boston Childrens Hospital and Professor of Bioengineering at the Harvard John A. Paulson School of Engineering and Applied Sciences. This assay could become a real game changer in this clinical area and it also should lead to more judicious use of antibiotics helping to decrease the worrisome rise we are seeing in antibioticresistant organisms. In a cohort of emergency room patients with suspected sepsis we saw that the assay picked up infection within an hour in  of patients who exhibited clinical symptoms of sepsis and equally importantly it did not falsely predict infection in healthy subjects or patients with inflammation triggered by other causes such as trauma. On the other hand blood cultures that we performed in parallel using the same samples only detected pathogens in  of the cases said Nathan Shapiro M.D. Ph.D. Director of Translational Research in the Center for Vascular Biology Research at BIDMC who worked with Ingbers team to conduct the clinical study. This highlights the advance this technology represents.  The diagnostic assay is built on FcMBL a genetically engineered pathogenbinding protein previously developed by Ingber and Michael Super a Wyss Senior Staff Scientist who coleads the Institutes pathogendetecting effort. FcMBL binds to pathogens and pathogenreleased fragments known as PathogenAssociated Molecular Patterns PAMPs by recognizing carbohydrate molecules on their surface. Previous efforts in Ingbers team at the Wyss Institute have established FcMBL as a key component of an advanced dialysislike pathogenextracting therapeutic device httpwyss.harvard.eduviewpressrelease and of a method for the fast retrieval of infectious pathogens httpwyss.harvard.eduviewpressrelease from complex clinical samples to enable their identification and antibody susceptibilities.  In our latest work we show that the FcMBLbased pathogendetecting assay is considerably faster and more accurate than any other available assay for systemic infection. We are currently working to ready it for highthroughput use in clinical and point of care situations and to accelerate it even further said Mark Cartwright Ph.D. a Staff Scientist at the Wyss Institute and a leadauthor on the study. As a prerequisite to their clinical study the Wyss Institutes team had successfully tested the assay in rat and pig models of infection with pathogenic E. coli bacteria. The animal models clearly told us that the assay can sensitively trace spikes of PAMPs released during antibiotic therapy or residual infectious PAMP materials even when no living bacteria circulate anymore in blood but they remain hidden inside internal organs. Thus this assay could be an excellent tool for monitoring ongoing infection and responses to antibiotics and dialysislike therapies for severe infections and sepsis said Mike Super Ph.D. Together the findings suggest that the FcMBLbased pathogen detection technology with its rapid handling time high sensitivity and broad specificity towards infectioncausing pathogens could provide a realworld advance to diagnose lifethreatening infections in both clinical microbiology laboratories and pointofcare settings."