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.

项目概要： 肺癌是美国癌症相关死亡的主要原因。低剂量胸部计算机 针对高危个体的断层扫描（CT）筛查项目可以降低肺癌特异性死亡率 降低了20%，总死亡率降低了6.9%。有一个越来越多的运动，以实施这种拯救生命的筛选， 常规做法，与美国的认可预防服务工作队，美国胸科 社会，和美国胸科医师学会，并愿意从付款人提供报销。 然而，在实现肺癌的早期检测和改善预后方面仍然存在许多挑战，包括： a）如何诊断具有不确定肺结节（IPN）的肺癌患者; B）如何确定 治疗后复发;以及c）如何在胸部CT筛查之前或同时定位生物标志物的使用，以减少 假阳性测试的成本和比率。可用一种快速、高灵敏度的检测方法来提高 生物标志物的定量具有革新对患有IPN的患者的管理的潜力。 根据第一阶段的STTR，我们建议采取下一步合理的步骤，将我们的小说翻译成商业作品 和专利技术，自由溶液分析（FSA）和补偿干涉读取器（CIR）， 已经显示出潜在地改善IPN诊断。FSA-CIR方法具有潜在的变革性 在生物医学研究和医学方面，代表了唯一的溶液相、无标记分子 相互作用测量方法，其灵敏度与荧光相当或更好，以及 与广泛的复杂矩阵兼容。这些特性使FSA-CIR能够用于 解决以前具有挑战性或棘手的应用，从增强肺癌检测， 在此提出的，以改善在体外在体内的相关性，为第一次在人体给药，以快速定量的低， 人类样本中含有大量化学物质，包括尿液中的新生儿阿片类物质和尿液中的化学神经毒剂 和血清。