Microfluidic Nitric Oxide Sensor

项目总结 临床传感器公司开发了一种可制造的用于测量人体体内一氧化氮的微流控传感器样机 全血。该STTR第二阶段项目旨在完成将其商业化所必需的几个关键目标 设备，包括一项临床研究，在该研究中，将对脓毒症的NO水平进行临床评估。脓毒症是最主要的 非心脏重症监护病房(ICU)的死亡原因。每年，败血症影响160万人，导致 25万人的死亡和医疗保健成本超过200亿美元。脓毒症的发病率和成本负担是稳定的 越来越多。广义上，脓毒症被理解为一种全身性反应的病理生理状态。 血液中细菌和/或真菌病原体的感染。脓毒症的定义不断演变为新的 关于这种疾病的研究不断涌现，临床医生试图更好地管理患者护理。然而，治疗 范式保持一致：及时发现和采取行动对减少脓毒症相关发病率至关重要 和死亡率，并降低与败血症护理相关的成本。目前，脓毒症及其相关疾病 综合征“缺乏特定的临床、影像、实验室或生化标记物来确定他们的 现身。“一氧化氮(NO)是宿主对感染的内源性反应，是一种致病因子 在脓毒症所致的器官功能障碍中起重要作用，已被认为是脓毒症的潜在生物标志物。直到最近， 目前还没有工具可以直接测定血液等复杂基质中的一氧化氮。我们已经开发出了一款第一款- 一种能够测量全血中一氧化氮的微流控传感器。有了这个工具，我们有了 结果表明，在临床前败血症模型中，NO水平迅速升高。在第一阶段，我们开发了一种 原型传感器，展示了其在血液中前所未有的分析性能，并证实了其能力 在临床前模型中监测病理生理NO水平。对于第二阶段，我们已经组建了一个团队 科学家、工程师和临床研究人员完成关键步骤，以获得 研究设备豁免(IDE)，并最终将该设备商业化。

PROJECT SUMMARY Clinical Sensors has developed a manufacturable prototype microfluidic sensor for measuring nitric oxide in whole blood. This STTR Phase II project aims to complete several key aims necessary to commercialize this device, including a clinical study where NO levels will be evaluated clinically in sepsis. Sepsis is the leading cause of death in non-cardiac intensive care units (ICUs). Each year, sepsis affects 1.6 million people, causing 250,000 deaths and healthcare costs over $20 billion. The incidence and cost burden of sepsis are steadily increasing. Broadly defined, sepsis has been understood as a pathophysiological state in response to systemic infection by bacterial and/or fungal pathogens in blood. The definition of sepsis is continually evolving as new research emerges about this disease and clinicians seek to better manage patient care. However, the treatment paradigm remains consistent: prompt detection and action are critical for reducing sepsis-associated morbidity and mortality and reducing the costs associated with sepsis care. Currently, sepsis and its associated syndromes “lack specific clinical, imaging, laboratory, or biochemical markers with which to confirm their presence.” Nitric oxide (NO) is endogenously produced in the host response to infection, is a causative agent in sepsis-induced organ dysfunction, and has been proposed as a potential biomarker for sepsis. Until recently, no tools have existed to measure NO directly in complex matrices such as blood. We have developed a first-in- class microfluidic sensor that enables measurement of NO in whole blood. With this tool, we have demonstrated that NO levels increase rapidly in preclinical models of sepsis. In Phase I, we developed a prototype sensor, demonstrated its unprecedented analytical performance in blood, and confirmed its ability to monitor pathophysiologic NO levels in a pre-clinical model. For Phase II, we have assembled a team of scientists, engineers, and clinical researchers to complete key steps on the critical path to receiving an Investigational Device Exemption (IDE) and ultimately commercialize this device.