Point-of-care device to identify patients at risk for preeclampsia

Period of Performance: 09/01/2017 - 07/31/2018


Phase 1 SBIR

Recipient Firm

Affinergy ,inc
Durham, NC 27709
Principal Investigator


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 16% annually of maternal deaths in the United States alone. African American women are disproportionately affected by preeclampsia in the United States, with a 1.5 to 2 fold increase in incidence over white or Hispanic women. Strikingly, the mortality rate for preeclampsia-associated deaths is up to 4-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, 60% 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.