ACCEL DIAGNOSTICS, LLC — Department of Health and Human Services SBIR Phase I: NICHD

Description

Project Summary PreeclampsiaPEis a pregnancy specific life threatening disorder and one of the leading causes of maternal and fetal morbidity and mortalityIt is responsible for approximatelyof maternal deaths in the US and is the leading cause of intensive care unit admissions in theweeks following deliveryRates of severe PE have tripled sinceThe diagnosis of PE is complicated by heterogeneity in the clinical presentation and symptom overlap with other medical conditions seen during pregnancyMaternal and perinatal outcomes for women with PE can be significantly improved if the condition is identified early and intervention and treatment strategies can be accessed quicklyThe current gold standard in clinical practice is to screen women at risk for PE based on clinical history and risk factorsWhile this strategy is well acceptedit remains a broadband screening with limited specificity and a high rateof false positivesRecent studies have shown that measurement of PlGF and sFltin the blood permit tracking the disease onset in patients at high risk for developing PEThere is an urgent need for the development of an innovative device for a rapidportableand cost effective testing of PE that leverages these biomarkers and can be used in a wide variety of health care environmentsnamely centralized laboratoriesphysicianandapos s officesand at homeThe objective of this Phase I proposal is to develop a novel reader free point of carePoCdevicePreeMofor the monitoring and management of PEPreeMo is an elegantly simpleinexpensiverapidaccurate and easy to use device to measure quantitatively both PlGF and sFltin a single testin less than two minutesfrom finger prick blood sampleImportantlythe PreeMo device will feature all of the characteristics required for successful use in low resource settings with an ultimate goal of becoming FDA cleared for home useThe development plan will follow a Phase I for the identification and optimization of affinity reagentsand a Phase II to pre clinically validate the PreeMo assay with clinical samples from women with a confirmed diagnosis of PESpecificallythis Phase I efforts will focus on comprehensive development of the multiplex assay format and extended pre clinical validationAimPreeMo Development and OptimizationWe will develop a multiplex assay prototype capable of performing bioassays for sFltand PlGF in parallel from a single blood sampleAimPreeMo Pre clinical validation vsbenchmark lab based devicePreeMo prototype test cards will be challenged with serum collected from pregnant women with confirmed PE along with sample specific de identified medical historyBenchmarking will be performed against laboratory valuesThe successful development of this technology could significantly reduce hospitalization times and help prevent maternal and fetal morbidity arising from PE Project Narrative PreeclampsiaPEis a life threatening multi system disorder of pregnancy characterized by hypertension and a leading cause of maternal and fetal morbidity and mortalityaffectingtoof pregnant women worldwideIn this Phase I application we will develop the first point of care blood test for the monitoring and early diagnosis of the onset of PE during pregnancyThe development of this novel PE testPreeMoaddresses an unmet clinical needThe implantation of PreeMo in the clinical setting is expected to provide an immediate health benefit for millions of women and their at risk infantsand will substantially reduce the economic burden associated with this disorder