Pragma Health Corp. — Department of Health and Human Services STTR Phase I: NIAID

Description

PROJECT SUMMARYAn estimatedbillion antibiotic prescriptions were filled in the US fromDespite a national antibiotic education campaignapproximatelyof antibiotic prescriptions are unnecessaryAs a result of the over prescription of antibioticsthere is a current and pressing public health need for improved antibiotic stewardshipCompounding this problem are new modalities of healthcare like telemedicine thatwhile meeting patient demand for conveniencehave been shown to have higher antibiotic prescription ratesAs a resultthere is a pressing need for a tool that these remote providers can use to distinguish between bacterial infectionswhere antibiotics can be effectiveand viral infections where antibiotics are unneededIn this researchwe propose the development of Barcode Embedded Rapid DiagnosticsBERDsas a point of care test to measure a host biomarker signature in response to an infection in bloodThese tests have novel spatial patterning of reagents that allows them to automatically and quantitatively be analyzed by a mobile phone applicationOnce the biomarkers have been analyzed on the testa clinical decision support engine developed in this proposal will provide a confident diagnosisWe have assembled an interdisciplinary consortium that consists of biomedical engineeringpoint of care deviceand software development expertise through PragmaDxIncand biomarker assay development in the Department of Chemistry at Vanderbilt UniversityTo meet our shared goalsour specific aims willoptimize manufacturing conditions of BERDsdevelop and evaluate a machine learning clinical decision support engineand rigorously compare the performance of BERDs to standard clinical laboratory methods using de identified patient specimensA successful outcome of this Phase I STTR will be the development of a diagnostic test and clinical decision support engine that is capable of measuring multiple biomarkers in blood to differentiate the etiology of an infection at the point of carewith accuracy comparable to standard clinical laboratory assaysUpon completion of this effective demonstrationthe platform will be ready for a large scale clinical evaluation that will be the subject of a Phase II application PROJECT NARRATIVEAn estimatedof antibiotic prescriptions are unnecessaryAs a resultantibiotic resistance has developed into a major public health concernDiagnostic tools that can distinguish between varying etiologies of infection are necessary to curb this growing problem