Preeclampsia is a complication of pregnancy characterized by elevated blood pressure, proteinuria, and endothelial dysfunction involving multiple organ systems. Worldwide, preeclampsia is the largest cause of fetal and maternal morbidity and mortality, and accounts for nearly 16% of maternal deaths in the United States alone each year. Currently, there is no approved diagnostic test to predict which patients will develop preeclampsia. Patients with preeclampsia require hospitalization and continuous monitoring of the mother and fetus, thus, there is an urgent and unmet need for a diagnostic test that can identify those patients at risk for preeclampsia. Preeclampsia is diagnosed when a patient?s blood pressure measures ?140/90 mm Hg twice ?4 hours apart and either proteinuria or one of the following conditions is present: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema or visual disturbances. Significant efforts are underway to detect preeclampsia prior to disease onset. Recently, it was demonstrated that glomerular podocytes are shed into the urine of preeclamptic patients and can be visualized using podocyte-specific antibodies. Moreover, shed podocytes can be detected in the second trimester, prior to preeclampsia diagnosis, with high sensitivity and specificity. Methods to detect podocytes currently rely on overnight culture and sedimentation of cells onto collagen-coated slides or Cytospin, which is prone to high false-positive rates due to contaminating red blood cells (RBCs) or casts. Inconsistencies in the method of podocyte detection and lengthy, overnight incubations susceptible to contamination weaken the utility of podocytes as a diagnostic marker of preeclampsia. To this end, Affinergy is developing a slide platform that can specifically capture and retain the diagnostic podocytes, while moving the obscuring contaminants to a separate region of the slide. Such a technology is amenable to downstream immunocytochemistry, will improve the diagnostic quality of podocyte capture, and lead to significant cost savings by minimizing time and need for expensive equipment. In this Phase I application, we will focus on developing optimal peptide-modified slides for isolating podocyte visceral epithelial cells from urine to improve the diagnostic quality of clinical podocyte slide preparations.

Public Health Relevance

Preeclampsia is a life-threatening condition that affects nearly 300,000 pregnant women in the United States and is only diagnosed after disease onset. Recent research has shown that detection of podocytes shed in the urine in the second trimester is an accurate predictor of preeclampsia development later in pregnancy. Affinergy is developing a novel method to detect podocytes from urine to improve detection and treatment of preeclampsia.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HD090786-01
Application #
9253876
Study Section
Special Emphasis Panel (ZRG1-EMNR-W (10)B)
Program Officer
Ilekis, John V
Project Start
2016-09-22
Project End
2017-08-31
Budget Start
2016-09-22
Budget End
2017-08-31
Support Year
1
Fiscal Year
2016
Total Cost
$299,999
Indirect Cost
Name
Affinergy, LLC
Department
Type
DUNS #
078296854
City
Durham
State
NC
Country
United States
Zip Code
27709