Translation of Interferometric-based Free-solution Assay Methodology

基于干涉测量的自由溶液测定方法的转化

• 批准号: 10254477
• 负责人: DARRYL J. BORNHOP
• 金额: $ 29.97万
• 依托单位: MERU BIOTECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10254477
• 关键词: Address; Advisory Committees; American; Benign; Binding; Biological Assay; Biological Markers; Biomedical Research; Blinded; Blood; Blood capillaries; Bread; Cancer Detection; Cancer Etiology; Cancer Patient; Cells; Certification; Cessation of life; Chemicals; Chest; Classification; Complex; Computer software; Data; Data Analyses; Data Collection; Detection; Diagnosis; Diagnostic; Dose; Drops; Drug Screening; Early Diagnosis; Erythrocytes; Evaluation; Exhibits; Fluorescence; Funding; Generations; Glycerol; Human; Hydration status; In Vitro; Individual; Label; Laboratories; Lasers; Legal patent; Life; Ligands; Lung nodule; Malignant Neoplasms; Malignant neoplasm of lung; Measurement; Measures; Medicine; Methodology; Methods; Molecular Conformation; Monitor; Morbidity - disease rate; Movement; Neonatal; Opioid; Optics; Patients; Performance; Phase; Physicians; Physiological; Positioning Attribute; Preparation; Preventive service; Procedures; Property; Reader; Reagent; Recurrence; Research; Risk; Risk Assessment; Sampling; Savings; Screening for cancer; Serum; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Societies; Soil; Technology; Testing; Tissues; Training; Translating; Translations; Tumor Markers; United States; Urine; base; cancer diagnosis; cancer risk; chest computed tomography; cohort; college; computed tomography screening; cost; detection method; detection sensitivity; first-in-human; graphical user interface; high risk; improved; improved outcome; in vivo; instrument; mortality; nerve agent; new technology; novel; operation; patient stratification; pollutant; potential biomarker; prognostic assays; prototype; routine practice; screening; screening program; willingness

Project Summary: Lung cancer is the leading cause of cancer-related deaths in the United States. Low dose chest computed tomography (CT) screening programs that target high-risk individuals can reduce lung cancer-specific mortality by 20% and overall mortality by 6.9%. There is a growing movement to implement this life saving screening into routine practice, with endorsements from the U.S. Preventive Services Task Force, the American Thoracic Society, and the American College of Chest Physicians, and a willingness from payers to provide reimbursement. Yet, numerous challenges still exist to realize early detection and improved outcomes for lung cancer, including: a) how to diagnosis lung cancer patients with indeterminate pulmonary nodules (IPNs); b) how to determine recurrence after therapy; and c) how to position biomarker use prior or alongside chest CT screening to decrease the cost and rates of false positive tests. The availability of a rapid, high sensitivity detection method to improve the quantification of biomarkers has the potential to revolutionize management of patients with IPNs. Under this Phase I STTR, we propose to take the next logical steps toward commercial translation of our novel and patented technologies, the free-solution assay (FSA) and the compensated interferometric reader (CIR) that has been shown to potentially improve IPN diagnosis. The FSA-CIR methodology is potentially transformative with respect to biomedical research and medicine, representing the only solution-phase, label-free molecular interaction measurement methodology with sensitivity comparable to, or better than, fluorescence, and compatible with a wide range of complex matrices. These properties have enabled FSA-CIR to be used to address previously challenging or intractable applications ranging from enhanced lung cancer detection, as proposed here, to improved in-vitro in-vivo correlations for first in human dosing, to the rapid quantification of low abundance chemicals in human samples, including neonatal opioids in urine and chemical nerve agents in urine and serum.

项目摘要： 肺癌是美国与癌症有关的主要原因。计算低剂量的胸部 瞄准高风险个体的层析成像（CT）筛查计划可以降低肺癌特异性死亡率 增加20％，总死亡率增加6.9％。越来越多的运动来实施这种挽救生命的筛查 常规实践，随着美国预防服务工作队的认可，美国胸部 社会和美国胸医师学院，以及付款人提供报销的意愿。 然而，仍然存在许多挑战以实现早期发现和改善肺癌的预后，包括： a）如何诊断不确定的肺结节（IPN）的肺癌患者； b）如何确定 治疗后复发； c）如何将生物标志物在先验或胸部CT筛选旁边使用以减少 假阳性测试的成本和费率。快速，高灵敏度检测方法的可用性 生物标志物的量化有可能彻底改变IPN患者的管理。 在此阶段我的STTR下，我们建议采取下一个逻辑步骤，用于我们的小说的商业翻译 和专利技术，自由解决方案测定（FSA）和补偿干涉读取器（CIR） 已证明可以改善IPN诊断。 FSA-CIR方法可能会发生变化 关于生物医学研究和医学，代表唯一的溶液相，无标签的分子 相互作用测量方法的灵敏度可与荧光相当或更好，并且 与广泛的复杂矩阵兼容。这些属性使FSA-CIR用于 解决以前挑战或顽固的应用，从增强的肺癌检测等 在此提议，以改善人类剂量首次的体外体内相关性，以快速定量 人类样品中的丰度化学物质，包括尿液中的新生儿阿片类药物 和血清。