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

Description

Preeclampsia is a complication of pregnancy characterized by elevated blood pressureproteinuriaand endothelial dysfunction involving multiple organ systemsWorldwidepreeclampsia is the largest cause of fetal and maternal morbidity and mortalityand accounts for nearlyof maternal deaths in the United States alone each yearCurrentlythere is no approved diagnostic test to predict which patients will develop preeclampsiaPatients with preeclampsia require hospitalization and continuous monitoring of the mother and fetusthusthere is an urgent and unmet need for a diagnostic test that can identify those patients at risk for preeclampsiaPreeclampsia is diagnosed when a patient s blood pressure measuresmm Hg twice at leasthours apart and either proteinuria or one of the following conditions is presentthrombocytopeniarenal insufficiencyimpaired liver functionpulmonary edema or visual disturbancesSignificant efforts are underway to detect preeclampsia prior to disease onsetRecentlyit was demonstrated that glomerular podocytes are shed into the urine of preeclamptic patients and can be visualized using podocyte specific antibodiesMoreovershed podocytes can be detected in the second trimesterprior to preeclampsia diagnosiswith high sensitivity and specificityMethods to detect podocytes currently rely on overnight culture and sedimentation of cells onto collagen coated slides or Cytospinwhich is prone to high false positive rates due to contaminating red blood cellsRBCsor castsInconsistencies in the method of podocyte detection and lengthyovernight incubations susceptible to contamination weaken the utility of podocytes as a diagnostic marker of preeclampsiaWe have identified proprietary peptides that bind with high affinity to podocytes but not to blood or urothelial cellsand we have developed a cell specific coating for glass slides that provides a simplereproducible method for preparing optimal capture slides from samples contaminated with blood and urothelial cellsA reduction in non diagnostic results will improve the quality of podocyte capture and lead to significant cost savings by minimizing turnaround time and the need for expensive equipmentAt the conclusion of this Phase II projectwe will have sufficient data in hand to rapidly bring our peptide conjugated slides to market PROJECT NARRATIVE Preeclampsia is a life threatening condition that affects nearlypregnant women in the United States and is only diagnosed after disease onsetRecent research has shown that detection of podocytes shed in the urine in the second trimester is an accurate predictor of preeclampsia development later in pregnancyAffinergy is developing a novel method to detect podocytes from urine to improve detection and treatment of preeclampsia