Miniaturized Global Coagulation Assay System in Neonatal and Pediatric Settings

Project SummaryAtantares Corpis seeking funding to develop a standardized foundation of thrombosis evaluationdriven through the principle of unification of standard laboratory and specialized hemostasis testinginclusive of a diversity of tests such as thromboelastographyTEGPT APTTmultiple electrode aggregometer etcwith the potential for iterative advance and multiplexingClinical realization of such a platform is far from the mere addition of various tests into a single unitbut transformativeparticularly in the pediatric cases where innate diversity in hemorrhagic and thrombotic status is juxtaposed diversity in disease and treatmentFlexible platforms are requiredEqually importantsensor miniaturization through our MEMS microfluidic approach significantly reduces required blood volumetest and dead spaceto perform these various assaysmaking it ideal for pediatric patientsWith deep expertise in MEMS technologyAtantares Corp has designed and is reducing to practice miniaturized and accurate modules of a diversity of hemostasis assays that can be used in isolationin serialor in parallelizable fashion at a fraction of the cost and footprint of current stand alone systemsThis technology also synergizes closely with the academic mission of DrKolandaivelu who has examined in detailthe patient specific underpinnings of patient specific thrombotic events following endovascular manipulations and in an effort to better understand the blood borne contributors to riskdeveloped multi parameter methods of mapping an individual s hemostatic state in high definitionAvailability of a modular tool can interface directly into existing workflows and provider preferencesat the same timebeing leveraged to cost effectively and systematically build out the needed evidence base for new applications despite diverse pediatric scenariosinnate variabilityECMOCHDarrhythmiashemophiliascoagulopathiesNICU settingsetcIn the scope of this SBIR programAtantares Corpwill demonstrate the key advantages of MEMS microfluid technology in functional global hemostasis assays through two specific aims that seek toCreate high accuracy MEMS sensors for functional hemostasis assessmentexemplified herein as a uTEG unitnoteTEG is exemplary of a complex module with growing clinical valueas well asGlobal assay optimization to maximize signal noise at minimal test volume Project NarrativeManagement of clotting and bleeding diseases in the pediatric patient is fraught with difficultyProven diagnostic tools that capture the breadth of clotting and bleeding variability and meet the constraints of the pediatric environment do not existThis project will demonstrate the key advantages of a modular Micro Electro Mechanical SystemsMEMSbased sensing system in functional global hemostasis assaysThis should benefit pediatric patients in diverse scenarios such as innate variabilitycoronary heart diseasearrhythmiashemophiliascoagulopathiesneonatal intensive care settingsetc by enabling the development of a modularrobustpoint ofcare pediatric global hemostasis assay instrument