Redbud Labs, Inc. — Department of Health and Human Services SBIR Phase II: R

Description

ABSTRACTRedbud Labs proposes to develop a low costintegrated microfluidic system to purify and concentrate pathogens directly frommL of whole bloodwith the goal of improving the sensitivity of downstream blood culture and molecular diagnostic assays used in sepsis diagnosis and treatmentPhase I studies have demonstrated that our technologybased on actuated surface attached postsASAPscan achieve high binding efficiency from a complex matrixsuch as whole bloodwithout foulingOur goal for this Phase II project is to develop a working prototype of the pathogen purification systemvalidate the system using clinical blood samplesand prepare for scale upThe specific aims of this proposal are todevelop an integrated pathogen purification systemvalidate the system using clinical samplesandoptimize ASAP fabrication methods to support scalable productionPrior to commencing the work in Phase IIwe will complete an Aimwhich focuses on evaluating the binding chemistry efficiency of the capture chamberusing the broad spectrum MBL antibodythat can bind andgtof pathogens that infect bloodin place of the E coli specific antibody used in Phase I studiesThe integrated system in Phase II will be validated using opportunistic clinical blood samples that are routinely collected from patients admitted to the ICU at Duke University HospitalAdditionallyprocess developmentsuch as wafer level surface functionalizationASAP packaging for integration with a cartridge formatand shelf stability studies will be conducted to ensure expected product performance by the time it reaches the end userThe outcome of this project will be an integratedinexpensiveand simple system that could transform the current status of pathogen identification and drug susceptibility testingparticularly for rare and low number pathogens in bloodThe broader impact of this system is the simplification of capturerecovery and concentration of any analyte from whole blood which could improve the speed and sensitivity of in vitro diagnostics NARRATIVE The proposedintegratedpathogen purification system will fill a critical unmet need for expediting and improving the sensitivity of pathogen strain identification and drug susceptibility assays used for sepsis diagnosis and treatmentparticularly for rare and low number pathogens