SBIR Phase I: BioSense AMD - A Point-of-Care Device for Monitoring Airway Inflammation

该小型企业创新研究（SBIR）第一阶段项目旨在开发一种即时生物医学设备，用于快速定量测量气道炎症。 目前，测量气道炎症和疾病控制的方法是困难的。 呼吸分析的最新创新为更好地了解气道疾病提供了机会。 然而，由于成本和可用性，这些创新的范围受到限制。包括哮喘、慢性阻塞性肺病（COPD）、肺气肿和肺动脉高压在内的慢性下呼吸道疾病是美国第四大死因，也是全球所有国家和收入水平的主要死因。迫切需要更好地监测和管理这些慢性下呼吸道疾病的方法，以提高生存率和患者的生活质量。使用先进的化学系统，该技术将测量呼出气冷凝物（EBC）中的炎症生物标志物。 该项目的成功将深刻影响基础肺部研究，并通过改善健康和减轻医疗保健系统的负担创造广泛的社会价值。这对服务不足的城市社区特别有价值，因为空气质量差会导致呼吸道疾病的严重程度增加。该产品也具有巨大的商业潜力，能够降低成本和简化治疗，在一个每年价值超过100 B美元的行业中。这个小型企业创新研究（SBIR）第一阶段项目旨在开发和实施一种先进的专有自动荧光试剂混合和检测系统，用于通过实时呼吸分析即时测量气道炎症。过氧化氢报告了气道炎症，这是哮喘和慢性阻塞性肺疾病（COPD）等呼吸系统疾病的关键因素，但难以在护理点准确测量。目前选择的方法包括高度侵入性支气管肺泡灌洗（BAL），耗时和昂贵的实验室过氧化氢测定，或部分呼出一氧化氮（FeNO），这提供了气道炎症的不完整的图片。该项目将填补这一分析空白，并提供一个有价值的解决方案，以监测患者的气道炎症在护理点。在第一阶段开发测量呼出过氧化氢的系统的拟议目标将包括：设计用于优化检测限和再现性的基于荧光的试剂输送和混合;配备优化的光子检测技术和内置涡旋混合器的坚固紧凑的读取器;以及对过氧化氢与潜在干扰分析物的灵敏度和选择性的仔细分析。该奖项反映了NSF的法定基金会的使命是履行其使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评价，被认为值得支持。

This Small Business Innovation Research (SBIR) Phase I project aims to develop a point-of-care biomedical device for the rapid and quantitative measurement of airway inflammation. Currently, methods to measure airway inflammation and disease control are difficult. Recent innovation in breath analysis has provided opportunity to better understand airway disease. However, the reach of these innovations has been limited due to cost and availability. Chronic lower respiratory diseases including asthma, chronic obstructive pulmonary disease (COPD), emphysema, and pulmonary hypertension are the fourth leading cause of death in the United States and a leading cause of death worldwide across all countries and income levels. There is an urgent need for methods to better monitor and manage these chronic lower respiratory diseases to improve survival and patients’ quality of life. Using an advanced chemical system, the proposed technology will measure a biomarker of inflammation in exhaled breath condensate (EBC). Success of this project will deeply impact fundamental pulmonary research and create broad societal value by improving health and reducing burdens on the healthcare system. This will be particularly valuable to underserved urban communities where poor air quality leads to increased severity of respiratory diseases. This product also has significant commercial potential, with the ability to reduce costs and streamline treatment in an industry valued over $100 B annually.This Small Business Innovation Research (SBIR) Phase I project aims to develop and implement an advanced proprietary automated chemiluminescent reagent mixing and detector system for instantaneous measurement of airway inflammation by real-time breath analysis. Hydrogen peroxide reports on airway inflammation, which is a critical factor in respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD), but is difficult to accurately measure at the point-of-care. The current methods of choice include highly invasive bronchoalveolar lavage (BAL), time-consuming and costly laboratory hydrogen peroxide assays, or fractional exhaled nitric oxide (FeNO), which provides an incomplete picture of airway inflammation. This project will fill this analysis gap and provide a valuable solution to monitoring airway inflammation in patients at the point-of-care. The proposed aims for developing a system to measure exhaled hydrogen peroxide in Phase I will include: a cartridge-based reagent delivery and mixing designed to optimize limit of detection and reproducibility; a robust and compact reader equipped with optimized photon detection technology and built-in vortex mixer; and careful analysis of sensitivity and selectivity for hydrogen peroxide versus potentially interfering analytes.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.