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

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 annually of maternal deaths in the United States alone African American women are disproportionately affected by preeclampsia in the United States with a to fold increase in incidence over white or Hispanic women Strikingly the mortality rate for preeclampsia associated deaths is up to fold higher in African American women Several factors have been attributed to this disparity including higher incidence of comorbidities delayed detection of symptoms misdiagnosis and differences in socioeconomic and insurance status Moreover of preeclampsia related deaths were found to have been preventable 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 Significant efforts are underway to detect preeclampsia prior to disease onset Recently it was demonstrated that glomerular visceral epithelial cells i e podocytes are shed into the urine of preeclamptic patients and 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 which is time consuming and susceptible to contamination or the Cytospin technique which is prone to high false positive rates due to contaminating red blood cells RBCs or casts mucoprotein secretions Inconsistencies in the method of podocyte detection and lengthy overnight incubations followed by immunofluorescence weaken the utility of podocytes as a rapid diagnostic marker of preeclampsia To this end Affinergy is developing a point of care device that will capture isolate and allow rapid quantification of diagnostic podocytes Such a technology will improve the 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 magnetic beads for isolating podocytes PROJECT NARRATIVE Preeclampsia is a life threatening condition that affects nearly pregnant women in the United States and disproportionately affects African American women 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