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

这项小型企业创新研究（SBIR）一期项目旨在开发一种即时医疗生物医学设备，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亡原因，也是全球所有国家和收入水平的主要死亡原因。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，该技术将测量呼出冷凝水（EBC）中的炎症生物标志物。该项目的成功将对肺部基础研究产生深远影响，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尤其有价值，因为空气质量差导致呼吸系统疾病的严重程度增加。该产品还具有巨大的商业潜力，能够降低成本，简化每年价值超过1000亿美元的行业的处理流程。这项小型企业创新研究（SBIR）一期项目旨在开发和实施一种先进的专有自动化化学发光试剂混合和检测系统，通过实时呼吸分析即时测量气道炎症。过氧化氢报告气道炎症，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测定，或分数呼出一氧化氮（FeNO），这提供了气道炎症的不完整图像。该项目将填补这一分析空白，并为在护理点监测患者气道炎症提供有价值的解决方案。在第一阶段，开发一种测量呼出过氧化氢的系统的拟议目标将包括：一种基于药筒的试剂输送和混合，旨在优化检测极限和再现性；一个强大的和紧凑的阅读器配备了优化的光子探测技术和内置涡流混合器；仔细分析过氧化氢与潜在干扰物的敏感性和选择性。该奖项反映了美国国家科学基金会的法定使命，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.