An Integrated Device for Rapid Bacteremia Diagnosis from Whole Blood

DESCRIPTIONprovided by applicantBloodstream infections caused by bacteria are a leading cause of death in the US and accounts for almostof all hospital deathsGiven that this disease accounts forof all ICU usageit is not only fatal but it is by far the costliest disease to the American healthcare systeminducing an economic burden of $B annuallyConsidering the rate at which the disease developsearly and targeted antibiotic treatment is the most crucial factor for improving patient outcomeThe reality of the current situationhoweveris troublesomewhile proper treatment options are readily availabletargeted antibiotic therapy is seldom administered early enough in the disease s time course to be of maximal benefit due to a lack of timely informationThis is largely due to current diagnostic standards which require multiple time consuming culturing stepsultimately leading to a diagnostic delay as long asdaysAs a consequencephysicians often resort to empirically designed broad spectrum antibioticcocktailswhich are cost intensiveless effectiveincrease complicationsand significantly increase the prevalence of drug resistant pathogensWe have developed and validated with clinical specimens a Pathogen IdentificationPIDassay that allows species level identification of rtof bacteremia inducing pathogens directly from bloodthus removing the "culturing barrier"Our PID assay employs a unique sample preparation methodology combined with the innovative use of a synthetic nucleic acid analogue with unmatched kinetics and target detection capabilitiesThis application focuses on the automation of the entire workflow into a fully integratedsample to answer consumable enabling the completely automated identification of pathogens directly from phlebotomy specimensin underhoursWe anticipate that the PID system we propose will have a profound clinical impactboth by providing a means to develop a hypothesis driven first line intervention days faster than currently possible and by reducing the excessive and unnecessary use of antimicrobialsIn order to succeed in this endeavorwe have put together a top notch team including experts in assay developmentsynthetic nucleic acid analoguesthe design and implementation of sample to answer diagnosticsand biomedical instrumentationAdditionallywe have enlisted key strategic advisors in clinical microbiologysurface chemistryand nucleic acid analogues as well as successful entrepreneurs experienced in the commercialization of diagnostic devicesTogetherwe will build upon our impressive initial resultsand develop an automated and culture free PID system culminating in a performance assessment study with clinical specimens in collaboration with Tufts Medical CenterHaving achieved our Specific Aimswe will develop deployable instrumentation consumables and validate our diagnostic in preparation for the pivotal clinical trial