SBIR Phase II: Integrated Point-of-Care System for Rapid Pathogen Identification and Characterization

SBIR 第二阶段：用于快速病原体识别和表征的集成护理点系统

• 批准号: 2321834
• 负责人: Amogha Tadimety
• 金额: $ 99.78万
• 依托单位: Nanopath Inc.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2321834&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Integrated; Point

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is improved access to state-of-the-art molecular diagnostic technologies in areas of significant unmet clinical need, such as women’s health. During the NSF I-Corps Program, the team identified urinary tract infections (UTIs) as pressing problem due to the currently lengthy clinical workflows, significant unmet clinical need, and large disease incidence. UTIs are one the most common causes of a healthcare visit for women in the United States and represent one of largest sources of antibiotic prescriptions in the country. Untreated UTIs can lead to severe complications for the patient, including systemic bacterial infections such as bacteremia. Despite the severity and prevalence of UTIs, diagnostic methodologies remain extremely time-consuming and rely on antiquated, culture-based methodologies for pathogen detection. This time-intensive diagnostic workflow typically leaves women in pain for up to three days before they are prescribed the appropriate antibiotic therapy. As a result of shortcomings in current healthcare workflows, women who have limited access to care are subject to longer result wait times, and often never receive the appropriate treatment. This Small Business Innovation Research (SBIR) Phase II project utilizes a novel nanosensor embedded into an integrated diagnostic consumable for rapid detection of target nucleic acid sequences directly from patient samples. The consumable is coupled to a proprietary bench-top readout instrument for test analysis and result reporting at the point-of-care. The technology eliminates the need for bacterial culture and nucleic acid amplification through an ultrasensitive optical detection modality, providing species-level information and genotypic antibiotic resistance data within minutes. Applications of the proposed platform translate beyond UTIs to other clinical scenarios that currently employ lengthy culture-based or amplification-based diagnostic workflows, such as sexually transmitted infections and respiratory infections. Successful product commercialization will require meeting clinically actionable timescales and assay performance benchmarks. Of importance is the development of a simple, integrated workflow for healthcare workers to enable single-step operation at the point-of-care. The Phase II technical objectives focus on the development and pilot-scale fabrication of the nanosensor, the optimization of sensitivity and robustness of data analysis methodologies to inform down-selection of reader optical hardware, and system integration and user testing.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.

该小企业创新研究 (SBIR) 第二阶段项目的更广泛影响/商业潜力是在 NSF I 期间改善未满足临床需求领域（例如妇女健康）获得最先进的分子诊断技术的机会。 Corps 计划中，该团队将尿路感染 (UTI) 确定为紧迫问题，因为目前临床工作流程冗长、临床需求未得到满足，而且尿路感染 (UTI) 发病率高，是美国女性就医的最常见原因之一。尽管尿路感染非常严重且普遍，但未经治疗的尿路感染可能会导致患者出现严重的并发症，包括菌血症。这种耗时的、基于培养的病原体检测方法通常会让女性在接受适当的抗生素治疗之前承受长达三天的痛苦。使用权该小型企业创新研究 (SBIR) 第二阶段项目利用嵌入集成诊断耗材的新型纳米传感器，直接快速检测来自患者的目标核酸序列。该耗材与专有的台式读出仪器相结合，可在护理点进行测试分析和结果报告，该技术通过超灵敏的光学检测方式消除了细菌培养和核酸扩增的需要，从而提供了物种检测。等级所提出的平台的应用不仅限于尿路感染，还适用于目前采用冗长的基于培养或基于扩增的诊断工作流程的其他临床场景，例如性传播感染和呼吸道感染。临床上可行的时间表和性能基准是为医护人员开发简单、集成的工作流程分析，以实现护理点的单步操作。第二阶段的技术目标侧重于开发和中试规模的制造。的纳米传感器、数据分析方法的灵敏度和鲁棒性优化，以告知阅读器光学硬件的向下选择，以及系统集成和用户测试。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进行评估，被认为值得支持以及更广泛的影响审查标准。