BAEBIES, INC. — Department of Health and Human Services SBIR Phase I: NICHD

Description

ABSTRACTNear Patient Acute Kidney Injury Biomarker Analysis in Critically Ill NeonatesRFA HDAcute kidney injuryAKIcontributes to mortality and morbidity in critically ill neonatesThe identification and treatment of AKI are currently based on serum creatininesCrlevelshowevermounting evidence suggests that sCr alone is insufficient to predict or prevent renal injurysCr is in fact a measure of renal functionnot injurysCr levels usually rise many hours after a renal injuryrequire a substantial magnitude of renal dysfunction for detection and are diminished by fluid overloadEarlier detection of acute kidney injurycoupled with improved characterization of the underlying etiologymay halt the progression to severe kidney injury and improve long term damageMeasurement of sCr levels alone is insufficient to achieve this goalIn response to RFAthis Fast Track SBIR project aims to develop a novel microfluidic platformFINDERfor near patientminimally invasive analyses of multiple AKI biomarkers in critically ill neonatesThe system will rapidly and simultaneously measure creatinineCrplus four highly specific AKI biomarkersNeutrophil Gelatinase Associated LipocalinNGALCystatin CCysCInterleukinILand Kidney Injury MoleculeKIMfrom a singleldrop of whole blood or urineNGALCysCILand KIMeach have different temporal profiles in relation to the duration of renal injuryand different magnitudes of increase depending upon the precipitating insulte gischemic vstoxicThe combined analysis of Cr with thesebiomarkers will provide critical information on the probable cause and temporal course of AKI and may help delineate ongoing injury vsprevious damageThe automated FINDER AKI system can be used in various distributed settings and will perform all assays in approximatelyminutesResults of the AKI system will allow clinicians toadiagnose AKIbdifferentiate the etiology of AKIandcpredict clinical outcomes of critically ill infantsThe Specific Aims for Phase I of this project includedevelop an automated panel of assays for five critical AKI biomarkersCrNGALCysCILand KIMon the single use digital microfluidic cartridgeperform preliminary analytical validations of each individual assayanddemonstrate preliminary feasibility of the individual assays on discarded serum and urine samplesUpon successful completion of all assays oncartridge with high reliability and precisionthe focus of Phase II will be tooptimize reagent formulations for on cartridge drying and storagemultiplex all assays to perform simultaneously on the same cartridgeandpreliminary clinical validation of the complete AKI testing panel by method comparison to standard reference testsThe final product will be commercializable for the rapidefficient and accurate measurement of AKI biomarkers in both urine and blood from critically ill newbornsWe will seek FDA approval of the final productwhich will initially be marketed for use in pediatric patients in U Shospitalswith a potential future market towards other patients who may benefit from the innovative features of the platform PROJECT NARRATIVE Acute kidney injuryAKIcontributes to mortality and morbidity in critically ill neonatesEarlier detection of AKIcoupled with improved characterization of the underlying etiologymay halt the progression to severe kidney injury and improve long term damageThe goal of this Fast Track SBIR project is to leverage the Baebiesandaposnear patient FINDER platform to perform rapid analyses of multiple AKI biomarkers for the identification and monitoring of acute kidney injury and function in critically ill neonates