Sersense Inc — Department of Health and Human Services STTR Phase I: NICHD

Description

PreeclampsiaPEis a pregnancy specific disorder characterized by hypertension and commonly by the appearance of urinary proteinThis disorder occurs inof pregnancies worldwide and is the second leading cause of maternal fetal morbidity and mortality worldwideIn low resource settingsPE accounts for up toof maternal deathsThe etiology of this disease is poorly understoodThis confounds therapeutic intervention and makes delivery the only recourse for saving the mother and childPrognostic and diagnostic tests are highly desirable given the importance of this diseaseThe most widely used diagnostic criterion is proteinuriamghourswhich is based on either measured protein in ah urine collection or predicted from the protein creatinine ratio in a random urine sampleThis measurement commonly requires hospitalization overnight and has a relatively low predictive valueThe shortcomings of proteinuria and other clinical measurements with respect to rapid diagnosis have catalyzed the search for alternativemore sensitive biomarkers of PEThe fact that serum proteins such as albumin appear in the urine of PE patients suggests that the barrier filtration function of the kidneys is affected by the diseaseOur teamGarovichas a long standing research interest in understanding the role of renal injury in the pathogenesis and progression of PEThe Garovic lab discovered that specialized kidney epithelial cellspodocyteswere present in urine of PE patientsOur team recently demonstrated the presence of podocoyte specific extracellular vesiclesEVsin urine of PE patientsThe numbers of EVs and the levels of expression of EV surface markerspodocin and nephrincorrelated with the diagnosis of PEThe objective of our team at Sersense is to translate exciting research findings from Mayo Clinic into a simple and robust lateral flow assayLFAthat will quantify podocyte derived EVs and the ratio of podocinand nephrin expressing EVs for use as diagnostic markers of PE Preeclampsia is one of the most common causes of pregnancy complications in the United States and worldwideThe objective of this STTR grant application is to leverage research findings from Mayo Clinic to develop a simple point of care test for early and sensitive diagnosis of preeclampsia