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Point of care detection of extracellular vesicles in urine for diagnosis of preeclampsia

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD096993-01
Agency Tracking Number: R41HD096993
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-17
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Davis, CA 95616-5270
United States
DUNS: 079197046
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (530) 219-5583
Business Contact
Phone: (530) 309-8377
Research Institution
200 1ST ST SW
ROCHESTER, MN 55905-0001
United States

 Domestic Nonprofit Research Organization

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

* Information listed above is at the time of submission. *

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