Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection

ABSTRACT Improving Anticoagulation Monitoring in Pediatric PatientsUse of a Microfluidic Platform to Test Low VolumeBlood Samples Obtained by Heel Stick CollectionFast Track SBIRThe goal of this Fast Track SBIR project is to develop a near patient platform for laboratory monitoring of anticoagulantsheparinheparinoidsand oral direct Factor Xa inhibitorsin children utilizing blood obtained from heel stick or finger prickCurrentlyovermL of whole blood is required to perform the standard laboratory assays during anticoagulation monitoringand sample collection typically necessitates invasive venipunctureDue to the increase in blood sampling to monitor ongoing therapy for children and infants being treated with anticoagulantsthere is a critical unmet need for minimally invasive blood sampling methods and miniaturized blood tests that require small sample volumesBaebies Incproposes to collaborate with DrSitaram Emani from Boston Childrenandapos s Hospital to develop a microfluidic platform for near patient laboratory monitoring of anticoagulation using blood collected by minimally invasive transcutaneous punctureThis technology will be novel and innovative in that it is the first device to perform anticoagulation monitoring on an ultra small volume of blood collected by heel stick or finger prickThe product will simultaneously perform three key assaysanti thrombin functionATIIIFactor Xa activityFXaand FXa supplemented with exogenous ATIIIThe small volume format inherent to digital microfluidics enables several biochemical assays to be performed onL or less of whole blood and is perfectly suited for use in pediatric settings where frequent blood draws significantly increase the risk of iatrogenic anemiaBy combining three technically complex assays into a singleautomated platformwe can reduce sample toanswer time and personnel time needed to perform each individual assayThe aims of Phase I are totranslate FXa and ATIII assays onto the FINDERdigital microfluidic platformmultiplexassays on a single cartridgeandperform initial analytical validationThe key milestone and metric for progression to Phase II will be successful demonstration of multiplexed assays on one cartridge with high reliability and precisionThe Aims for Phase II are toutilize discarded whole blood samples to perform analytical validationoptimize techniques for blood sample collection to minimize contact activationandperform preliminary clinical validation of near patientminimally invasivelow volume sample testing by comparing to standard clinical values obtained by venipunctureThe research will be performed on the BaebiesandaposFINDER platforma compact near patient platform currently under final developmentAt the conclusion of Phase IIwe will have a commercializable diagnostic product for comprehensive management of anticoagulation therapies using low volume whole blood samples in a hospital or clinic settingOur final product will be submitted for FDA approval and will initially be marketed for use in pediatric patients in U Shospitals and clinics with a future market towards other patients who may experience the disadvantages of current testing methodologiesserial venipuncture and iatrogenic anemiaPROJECT NARRATIVE We aim to develop a near patient platform for laboratory monitoring of anticoagulantsheparinheparinoidsand oral direct Factor Xa inhibitorsin children utilizing blood obtained from heel stick or finger prickCurrentlyovermL of whole blood is required to perform the standard laboratory assays during anticoagulation monitoringand sample collection typically necessitates invasive venipunctureDue to the increase in blood sampling to monitor ongoing therapy for children and infants being treated with anticoagulantsthere is a critical unmet need for minimally invasive blood sampling methods and miniaturized blood tests that require small sample volumes