ANALYTICAL DIAGNOSTIC SOLUTIONS INC — Department of Health and Human Services SBIR Phase I: NICHD

Description

Abstract Neonates with high bilirubin levels can develop a fatal disorder known as KernicterusKernicterus has a death rate ofand causes brain damage and serious long term complicationsHigh bilirubin levels are the leading cause for readmission of newborns to the hospital in the firstweeks of lifeCurrent laboratory analyzers require a venipuncture for neonateswhich is difficult for the care providerpatient and parentWith the onset of illnessit is not uncommon for neonates loseof circulating blood volume to laboratory testingA NICHD workshop on NICUs concluded that there is a urgent need for metabolic analysis methods that require minimal volumes of bloodcan measure analytes in paralleland are accuratereliableand cost effectiveRajuA recent report by Market Research Futurestates that bythe Bilirubin Testing market will reachbillion dollarsIn Vitro Diagnostic SolutionsIVDSproposes the development of the first and only point of carePOCsystemtheBiliNowfor the determination of bilirubins from a finger or heel stickTheBiliNowwill be used in the Neonatal Intensive Care UnitNICUemergency roomERintensive care unitsICUand clinician s office providing immediate feedback to expedite treatmentThe BiliNow utilizes a microfluidic chip format that is minimally invasiverequiring onlymicroliters of whole bloodwhich is collected from a heel stick or fingerstickIn Phase I studieswe willTest solubilizing agents to ensure complete solubility of unconjugated bilirubinTest and eliminate hematocrit bias in the neonatal range oftoand finallyEvaluate a dose response of bilirubin with whole blood samplesMicrochips will be dosed and dried with chromophore sensors specific for conjugated and unconjugated bilirubinWhole blood will be spiked with each conjugated and unconjugated bilirubinover the analytical rangesPlasma will be separatedin situand the end color of each sensing well will be quantitated using percent reflectance and calculated mg dLvia a hand heldportable analyzersimilar to the glucose modelThe BiliNow provides results for both conjugated and unconjugated bilirubin in a single step withinminutesThe BiliNow technology has a clear advantage in the neonatal blood chemistry market as no other device can measure bilirubinfrom a single drop of bloodUpon successful completion of the Phase I AimsPhase II will focus on optimization of the platform to ensure linearity and precisionestablish intra day and inter day precision under Clinical and Laboratory Standards Institute guidelinesand evaluate preclinical samples with the BiliNow comparing results against an FDA approved methodthe Branalyzer Project Narrative High bilirubin levels are the leading cause for readmission of newborns to the hospital in the firstweeks of lifeIn some instancesbabies with high bilirubin levels can develop a fatal disorder known as KernicterusIn Vitro Diagnostic SolutionsIVDSproposes to develop a lab on a chippoint of care systemthe BiliNowwhich will be able to quantify conjugated and unconjugated bilirubin directly from a single drop of blood