A point-of-care device for phenylalanine determination

Abstract In Vitro Diagnostic SolutionsIVDSproposes to develop the only point of carePOCtest for the determination of L phenylalaninePhefrom a finger or heel stick sampleThe point of care testthePKU Nowwill be used as a home monitoring device for PKU patients and for diagnostic testing in developing regionsThe PKU Now will provide immediate feedback of whole blood phe concentrationallowing for stricter dietary complianceimprove the quality of lifeand reduce healthcare costsIn Phase I studieswe will resolve three outstanding issues before commercializing the systemnamely eliminating interferencesAimeliminating hematocrit bias in the range oftoAimand establishing agreement between thePKU Nowand a laboratory reference methodAimPhenylketonuriacommonly known as PKUis an inherited disorder that increases the levels of a substance called phenylalanine in the bloodPKU is the most common disorder of amino acid metabolismeffectinginpeoplegloballyMost cases of PKU are detected shortly after birth by newborn screeningIndividuals affected by PKU must monitor and control phe levels throughout their lives to avoid neurological complications includingpermanent intellectual disabilitiesseizuresdelayed developmentbehavioral problemsand psychiatric disordersWhole blood is collected in EDTA tubes or spotted onto Dried Blood SpotDBSCards by parentspatients or caregiversThese samples are sent to laboratories for measurement by tandem mass spec and results can take days to weeksThis complicated process for monitoring and controlling phe levelsresults in non compliancea decrease in quality of lifeas well as increased healthcare costs for treating complicationsThe PKU Now will provide real time phe levelsallowing parents and caregivers to promptly adjust their diets to help maintain optimal phenylalanine levelsIn Vitro Diagnostic SystemsIVDShas developed a prototype POC testin which phe can be quantified from amicroliters of sampleUpon successful validation ofPKU NowPhase II will ensure linearity and precisionestablish intra day and inter day precisionand evaluate preclinical data against tandem mass spec analysisall following CLSI guidelinesPKU Nowwill be the only point of care testing devicePOCTthat will allow the accurate measurement of L phenylalaninephelevels from a finger or heel stick Project Narrative PKU is the most common disorder of amino acid metabolismeffectinginpeoplegloballyWithout proper monitoring and treatmentthese patients can develop permanent intellectual disabilitiesseizuresdelayed developmentbehavioral problemsand psychiatric disordersIVDS propose the development of the PKU Now as a home monitoring point of care device and as well a diagnostic device in developing regions where new born screening is not available