A sample-to-answer diagnostic for neonatal bloodstream infections

PROJECT SUMMARY Neonatal septicemia is a life threatening disease that affects roughlyout of everylive births in the USwheredo not surviveCaused by an infection of the newborn bloodstream either at the time of birth or soon afterthe disease s initial clinical manifestations are often non specificvariableat times subtleand often common to signs of stressThus a core requirement to both to rule in a bloodstream infectionBSIand to ruleout a BSI is microbiological evidencewhich is currently only possible through blood culturesCultureshoweverdisplay two major weaknesses whichcrucial to outcomedelay the administration of the proper antimicrobialsLong turnaround time of days andhigh prevalence of false negative results due to maternal antibiotics and a reduced input blood volumeAs time is of essence for optimal outcomestreatment is generally initiated prior to microbial diagnosis with a cocktail of broad spectrumi enot personalizedantimicrobialsleaving the majority of patients treated inappropriately and those without the disease treated unnecessarilyIt is therefore critical to advance innovative diagnostic approaches which do not rely on culturing in order to facilitate a transition to an evidence based decision making process as soon as feasibleHaving met our and exceeded our Phase I Specific Aimsthis Phase II proposal focuses on development of a fully automated neonatal pathogen identificationNeo PIDplatform enabling thehands freeidentification of the most clinically prevalent pathogens directly from phlebotomy specimensin roughlyhourswithout the need to cultureThe Phase II proposed diagnostic device is expected to have profound impactboth by improving outcomes by providing a means to develop an evidence driven first line interventionand likewise by reducing the use of excessive and unnecessary antimicrobialsIn order to succeed in this endeavorwe have assembled a top notch team including experts in assay developmentartificial nucleic acidsand the implementation of automated diagnosticsAdditionallywe have enlisted key advisors in clinical microbiologysurface chemistryand pathology as well as successful entrepreneurs experienced in the commercialization of diagnostic devicesTogetherwe will build upon our impressive Phase I results and develop an automated platformdedicated to neonatal BSIsculminating in a performance assessment study with clinical specimensHaving achieved our Specific Aimswe will develop deployable instrumentation consumables and validate our diagnostic in preparation for the pivotal clinical trial