SBIR Phase I: Development of a SERS-based diagnostic platform for multiplexing ubiquitous inflammatory markers in cancer.

SBIR 第一阶段：开发基于 SERS 的诊断平台，用于多重癌症中普遍存在的炎症标记物。

• 批准号: 2348543
• 负责人: Mini Thomas
• 金额: $ 27.48万
• 依托单位: Amplified Sciences, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-03-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2348543&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; SERS; based

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project stems from the fact that cancer causes approximately 10 million deaths yearly worldwide, and the economic burden on cancer patients in the United States alone is estimated to be around $21 billion/yr, excluding lost productivity. Over 600,000 people die from cancer in the United States each year, and cancer cases among the younger population are on the rise. Currently, only a handful of cancers, such as breast, colon, cervical, and prostate, have recommended early screening, and sadly, 70% of cancer deaths are caused by cancers without recommended screening. Early detection, coupled with accurate monitoring and surgery in appropriate cases, appears to be the ideal strategy to improve outcomes and quality of life and reduce healthcare costs. The availability of novel diagnostic technology for minimally invasive biomarker analysis using biofluids to accurately predict malignancy potential would greatly benefit patients and clinicians in the early diagnosis and management of deadly cancers. Development of the technology proposed herein would have a broad impact on the cancer diagnostic space in terms of accurate early detection and diagnosis, quality of life, mortality, and healthcare burden. This Small Business Innovation Research (SBIR) Phase I project aims to develop multi-marker diagnostic assays to bridge a critical gap from biomarker discovery to diagnostic assay translation. This project leverages principles from synthetic chemistry, enzymology, spectroscopy, and engineering, leading to a novel biosensing platform that couples Surface-Enhanced Raman Spectroscopy (SERS) and a protease turnover assay to provide highly accurate methods for biomarker detection. This project will lead to developing next-generation sensors to meet the unique requirements for a multi-molecular protease activity assay from highly viscous, proteinaceous clinical samples and deliver a stackable assay workflow readily accessible to clinical laboratory staff with rapid turnaround. The technological hurdles that will be addressed during Phase I will include: 1) synthetic development of ultrasensitive SERS-active dyes and their conjugates with substrates of proteases associated with high-grade dysplasia in pancreatic cysts and other cancers, and 2) development and optimization of a multiplexed multi-protease turnover assay employing the aforementioned substrates using an automated-SERS detection platform with high-throughput capability for eventual commercialization in a CLIA lab setting. This technology has the potential to be transformative due to its multiplexing capability, high sensitivity and selectivity, cost-effectiveness, and reliable performance in complex biological fluids.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) 第一阶段项目的更广泛影响/商业潜力源于这样一个事实：癌症每年在全球造成约 1000 万人死亡，仅美国癌症患者的经济负担估计约为 21 美元十亿/年，不包括生产力损失。在美国，每年有超过 60 万人死于癌症，而且年轻人中的癌症病例正在增加。目前，只有少数癌症，如乳腺癌、结肠癌、宫颈癌和前列腺癌，建议进行早期筛查，遗憾的是，70% 的癌症死亡是由未经建议筛查的癌症引起的。早期发现，加上准确的监测和适当情况下的手术，似乎是改善结果和生活质量并降低医疗费用的理想策略。使用生物流体进行微创生物标志物分析的新型诊断技术的可用性可以准确预测恶性肿瘤的可能性，这将大大有利于患者和临床医生对致命癌症的早期诊断和治疗。本文提出的技术的发展将对癌症诊断领域在准确的早期检测和诊断、生活质量、死亡率和医疗保健负担方面产生广泛的影响。该小型企业创新研究 (SBIR) 第一阶段项目旨在开发多标记诊断检测方法，以弥合从生物标记物发现到诊断检测转化的关键差距。该项目利用合成化学、酶学、光谱学和工程学的原理，形成了一个新颖的生物传感平台，将表面增强拉曼光谱 (SERS) 和蛋白酶周转测定相结合，为生物标志物检测提供高度准确的方法。该项目将开发下一代传感器，以满足对高粘性蛋白质临床样品进行多分子蛋白酶活性测定的独特要求，并提供临床实验室工作人员易于使用且周转时间短的可堆叠测定工作流程。第一阶段将解决的技术障碍包括：1）合成开发超灵敏的 SERS 活性染料及其与胰腺囊肿和其他癌症中高度不典型增生相关的蛋白酶底物的缀合物，以及 2）开发和优化采用上述底物的多重多蛋白酶周转测定，使用具有高通量能力的自动 SERS 检测平台，最终在 CLIA 实验室环境中商业化。该技术由于其多路复用能力、高灵敏度和选择性、成本效益以及在复杂生物液体中的可靠性能而具有变革潜力。该奖项反映了 NSF 的法定使命，并通过使用基金会的知识产权进行评估，被认为值得支持。优点和更广泛的影响审查标准。