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

这个小型企业创新研究(SBIR)第一阶段项目旨在开发一种用于快速定量测量呼吸道炎症的护理点生物医学设备。目前，测量呼吸道炎症和疾病控制的方法很困难。最近呼吸分析方面的创新为更好地了解呼吸道疾病提供了机会。然而，由于成本和可获得性的原因，这些创新的影响范围有限。包括哮喘、慢性阻塞性肺疾病(COPD)、肺气肿和肺动脉高压在内的慢性下呼吸道疾病是美国的第四大死亡原因，也是所有国家和收入水平的全球主要死亡原因。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，以提高患者的存活率和生活质量。使用先进的化学系统，这项拟议的技术将测量呼出的呼吸冷凝液(EBC)中的炎症生物标志物。该项目的成功将对基础肺病研究产生深远影响，并通过改善健康和减轻医疗系统的负担创造广泛的社会价值。对于服务不足的城市社区来说，这将特别有价值，因为那里糟糕的空气质量导致呼吸道疾病的严重性增加。该产品还具有巨大的商业潜力，能够在一个每年价值超过1000亿美元的行业中降低成本并简化治疗。这个小型企业创新研究(SBIR)第一阶段项目旨在开发和实施先进的自动化化学发光试剂混合和检测系统，用于通过实时呼气分析实时测量呼吸道炎症。过氧化氢报告呼吸道炎症，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，但很难在护理点准确测量。目前选择的方法包括高侵入性支气管肺泡灌洗(BAL)、耗时且昂贵的实验室过氧化氢分析，或部分呼出的一氧化氮(FeNO)，后者提供了一幅不完整的呼吸道炎症图景。该项目将填补这一分析空白，并为在护理地点监测患者的呼吸道炎症提供有价值的解决方案。拟议的目标是开发一种在第一阶段测量呼出的过氧化氢的系统，该系统将包括：基于试剂盒的试剂输送和混合，旨在优化检测极限和重复性；配备优化的光子探测技术和内置涡流混合器的坚固紧凑的读取器；以及仔细分析过氧化氢的灵敏度和选择性与潜在干扰分析。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，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.