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

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Although international trends for maternal mortality have shown an overall decline, maternal mortality rates in the United States have increased by >25% since 2000. One of the leading causes for this increase is preeclampsia, a complication of pregnancy characterized by elevated blood pressure, proteinuria, and endothelial dysfunction involving multiple organ systems. Worldwide, preeclampsia is one of the leading causes of fetal and maternal morbidity and mortality, and annually accounts for nearly 16% of maternal deaths in the United States alone. Moreover, African American women are disproportionately affected by preeclampsia in the United States, with a 1.5- to 2-fold increase in incidence and a 4-fold increase in mortality rate. Several factors have been attributed to this disparity, but the leading cause is considered to be assessment errors by the patient’s provider. One explanation for this is the lack of a sensitive and specific diagnostic test to predict which patients have or will develop preeclampsia. Patients with preeclampsia require increased monitoring during their pregnancy and may even require extended hospitalization with 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 biomarker present in preeclamptic patients can be detected in the second trimester, prior to preeclampsia diagnosis, with high sensitivity and specificity. Affinergy is developing a point-of-care device that will capture, isolate, and allow rapid quantification of this biomarker and unambiguous diagnosis of preeclampsia. 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 II application, we will focus on developing optimal peptide- modified magnetic beads for isolating podocytes.