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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是使慢性阻塞性肺疾病(COPD)和与年龄相关的肺部疾病的早期诊断成为可能。在早期阶段可靠地发现这些疾病，通过减少肺部疾病对健康的影响和与治疗相关的成本，有可能显著改善疾病结果。简而言之，目前估计有1400万美国人患有肺功能测试(PFT)诊断的COPD，而1600万受试者预计将患有PFT未诊断的COPD，从而导致在严重阶段首次或初步诊断。目前还没有准确和早期的肺部健康评估，这意味着严重的医疗保健缺口--特别是对幼儿、老年人和慢性病受试者，因为肺诊断(如PFT)需要患者依从性，而CT、PET等对这些受试者有重大风险。仅在美国，就有1600万例PFT未确诊的COPD病例，一种新的肺部健康筛查诊断测试将解决COPD的“隐形”流行问题，并帮助监测暴露在一手和二手烟、电子烟蒸气和空气污染物中的影响。早期更频繁的肺部健康筛查将允许及时干预并限制重大医疗成本。这一小企业创新研究(SBIR)第一阶段项目将加快用于COPD早期诊断和干预的肺健康多点护理测试(XPOCT)的开发和商业化。POCT得到了概念验证、临床前数据和人类受试者对预后生物标志物的验证的支持，该生物标志物可以提供一流的基于家庭的快速和POC肺健康诊断(LHDx)，用于预测COPD肺气肿的发生和发展。其目标是开发一种有效、非侵入性和快速的LHDx，用于COPD-肺气肿的早期更频繁的筛查和诊断，而目前的标准护理诊断通常会遗漏这种情况。该项目有以下目标：(1)家庭和POC LHDx平台技术的特异性和敏感性的原型工程和标准化；(2)用于评估疾病预后的诊断分析特异性和敏感性的验证；以及(3)开发用于疾病严重性分析的实验室验证测试，并启动对家庭快速和POC LHDx商业化的监管批准。第一阶段项目将解决尚未得到满足的需求，即识别高危和高度易患慢性阻塞性肺疾病的个人，以便进行基于预后的早期干预。其结果将是开发一种新的、非侵入性的LHDX，用于量化COPD-肺气肿的开始和进展，用于量身定做的干预。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。

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.