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

虽然产妇死亡率的国际趋势显示总体下降，但2010年的产妇死亡率仍在下降。 美国自2000年以来增长了25%以上。这一增长的主要原因之一是 先兆子痫，一种妊娠并发症，其特征是血压升高，蛋白尿， 涉及多个器官系统的内皮功能障碍。在世界范围内，先兆子痫是导致 每年约占世界产妇死亡人数的16%， 只有美国。此外，非洲裔美国妇女不成比例地受到先兆子痫的影响， 美国，发病率增加1.5至2倍，死亡率增加4倍。几个因素 已经归因于这种差异，但主要原因被认为是患者的评估错误 提供商对此的一种解释是缺乏一种敏感和特异的诊断测试来预测哪些患者 患有或将要患上先兆子痫。先兆子痫患者在分娩期间需要增加监测。 怀孕，甚至可能需要延长住院时间，对母亲和胎儿进行持续监测; 因此，迫切需要一种诊断测试，可以识别那些有风险的患者， 先兆子痫正在进行重大努力，以在疾病发作前检测先兆子痫。最近，研究表明，先兆子痫患者中存在的生物标志物可以在妊娠中期检测到，在先兆子痫诊断之前，具有高灵敏度和特异性。Affinergy正在开发一种即时设备，可以捕获、分离并快速定量这种生物标志物，并明确诊断先兆子痫。这样的 这项技术将提高足细胞捕获的质量，并通过最大限度地减少时间来节省大量成本。 并且需要昂贵的设备。在第二阶段的申请中，我们将专注于开发最佳的肽- 用于分离足细胞的修饰的磁珠。

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.