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

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是使慢性阻塞性肺病（COPD）和年龄相关肺病的早期诊断成为可能。通过减少肺部疾病对健康的影响和与治疗相关的费用，在早期阶段可靠地发现这些疾病，有可能显著改善疾病结局。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，而预计有1600万受试者患有未经PFT诊断的COPD，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，这代表了一个重要的医疗缺口——特别是对于幼儿、老年人和慢性疾病患者，因为肺部诊断（如PFT）需要患者的依从性，而CT、PET等对这些受试者有很大的风险。仅在美国就有1600万例pft未确诊的慢性阻塞性肺病病例，一种新的肺部健康筛查诊断测试将解决“看不见的”慢性阻塞性肺病流行问题，并有助于监测暴露于第一和二手烟、电子烟蒸汽和空气污染物的影响。早期更频繁的肺部健康检查将允许及时干预并限制重大的医疗保健费用。这项小型企业创新研究（SBIR）一期项目将加速用于COPD早期诊断和干预的肺部健康多护理点测试（xPOCT）的开发和商业化。POCT得到了概念验证的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，该生物标志物可提供一流的快速家庭和POC肺健康诊断（LHDx），用于预测copd肺气肿的发生和进展。目标是开发一种有效的、非侵入性的、快速的LHDx，用于copd肺气肿的早期更频繁的筛查和诊断，目前的标准诊断通常会遗漏这些疾病。本项目有以下目标：(1)居家和POC LHDx平台技术的特异性和敏感性的原型工程和标准化；(2)验证该诊断方法评估疾病预后的特异性和敏感性；(3)使用定制软件开发用于疾病严重程度分析的实验室验证分析，并启动基于家庭的RAPID和POC LHDx商业化的监管批准。I期项目将解决未满足的需求，即识别高风险和高度易感发展为COPD的个体，进行基于预后的早期干预。结果将是开发一种新的、无创的LHDx，用于量化copd -肺气肿的发生和进展，以进行量身定制的干预。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。

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.