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

Description

SUMMARY ABSTRACT 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 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 mm Hg twice 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 PROJECT NARRATIVE Preeclampsia is a life threatening condition that affects nearly 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