SBIR Phase I: Development of a Lung Health Diagnostic Test for COPD and Prognosis-Based Early Intervention

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to enable early diagnosis of chronic obstructive pulmonary disease (COPD) and age-related lung conditions. Reliable detection of these diseases at an early stage has the potential for significantly improving disease outcomes, by reducing the health impact of lung diseases and the costs associated with the treatment. Briefly, 14 million Americans are currently estimated to have Pulmonary Function Test (PFT)-diagnosed COPD, while >16 million subjects are expected to have PFT-undiagnosed COPD leading to the first or initial diagnosis at the severe stages. Currently no accurate and early lung health assessments exist, representing a vital healthcare gap - especially for young children, elderly and subjects with chronic conditions, as lung diagnostics such as PFT require patient compliance and CT, PET etc., have significant risk for these subjects. With >16 million cases of PFT-undiagnosed COPD in the United States alone, a new lung health screening diagnostic test will address the “invisible” epidemic of COPD and help monitor impact of exposure to first- and secondhand- smoke, e-cig vapors and air pollutants. Early more frequent lung health screening will allow timely intervention and limit significant health care costs. This Small Business Innovation Research (SBIR) Phase I project will accelerate development and commercialization of a lung health multiplex point of care test (xPOCT) for early diagnosis and intervention of COPD. The POCT is supported by proof-of-concept pre-clinical data and human subject validation of a prognostic biomarker for delivering on first-in-class RAPID home-based and POC Lung Health Diagnostics (LHDx) for predicting initiation and progression of COPD-emphysema. The goal is to develop an effective, non-invasive and rapid LHDx for early more frequent screening and diagnosis of COPD-emphysema, commonly missed by current standard-of-care diagnostics. This project has the following objectives: (1) prototype engineering and standardization of the specificity and sensitivity of the home-based and POC LHDx platform technology; (2) validation of the diagnostic assay specificity and sensitivity for evaluating disease prognosis; and (3) development of a lab validation assay with custom software for disease severity analysis and initiate regulatory approval for commercialization of the home-based RAPID and POC LHDx. The Phase I project will address the unmet need for identification of individuals that are at-risk and highly susceptible to developing COPD for prognosis-based early intervention. The outcome would be development of a novel, non-invasive LHDx for quantifying COPD-emphysema initiation and progression for tailored intervention. 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.