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

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.