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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力源于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210亿美元/年，不包括损失的生产力。每年在美国，超过60万人死于癌症，年轻人口中的癌症病例正在增加。目前，只有少数癌症，例如乳腺癌，结肠，宫颈和前列腺，建议进行早期筛查，可悲的是，有70％的癌症死亡是由癌症引起的，而无需建议筛查。在适当情况下，早期发现，再加上准确的监测和手术，似乎是改善结果和生活质量并降低医疗保健成本的理想策略。使用生物流体准确预测恶性潜力的新型诊断技术用于微创生物标志物分析，这将在早期诊断和管理致命癌症的早期诊断和管理中受益匪浅。在此提出的技术的开发将在准确的早期发现和诊断，生活质量，死亡率和医疗保健负担方面对癌症诊断空间产生广泛的影响。这项小型企业创新研究（SBIR）I阶段项目旨在开发多标记的诊断测定法，以弥合从生物标志物发现到诊断分析翻译的关键差距。该项目利用合成化学，酶学，光谱和工程学的原理，导致一个新型的生物传感平台，该平台将表面增强的拉曼光谱（SERS）和蛋白酶转离测定法提供了高度准确的生物标志物检测方法。该项目将导致开发下一代传感器，以满足来自高粘性，蛋白质临床样品的多种分子蛋白酶活性测定的独特要求，并提供可堆叠的测定工作流程，可为临床实验室工作人员易于访问，并可以快速转移。在第一阶段将要解决的技术障碍将包括：1）超敏感性SERS活性染料的合成发展及其与胰腺蛋白酶基质的结合物与胰腺囊肿和其他癌症中高级异常增生相关的蛋白酶的基质，以及使用替代量的多发性驱动器的开发和优化，该型号使用了多发性的播种机，该杂货通过了过度播种，采用了逐渐播种的量子，采用了逐渐播种的量子。在CLIA实验室设置中最终商业化的高通量功能。由于其多重能力，高灵敏度和选择性，成本效益以及在复杂的生物流体中的可靠表现，这项技术具有变革性的潜力。该奖项反映了NSF的法定任务，并被认为是通过基金会的知识分子优点和广泛影响的审查标准通过评估来获得支持的。