STTR Phase I: Portable single cell cytology and predictive analysis platform for the early detection of epithelial cancers

STTR 第一期：用于上皮癌早期检测的便携式单细胞细胞学和预测分析平台

• 批准号: 2233372
• 负责人: Nicolaos Christodoulides
• 金额: $ 27.5万
• 依托单位: ORALIVA, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2025-01-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2233372&HistoricalAwards=false
• 关键词: STTR; Phase; Portable; single; cell

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project will address the need for an accessible method to identify early-stage epithelial cancers, with high accuracy, earlier and at lower cost than is currently available. In 2020, the total cost of cancer care was nearly $210 billion. Due to the nature of current cancer diagnostics, most cancers are diagnosed and treated during late-stages. This results in a large economic burden to patients, families, healthcare providers, and facilities. To advance the health and welfare of the public and reduce the nation’s healthcare burden, there is a need for cancer screening, diagnostic, and monitoring devices that are non-invasive, cost-effective, easy-to-use, and accurate. The proposed platform for the early detection of multiple types of epithelial cancers 1) addresses the lack of effective non-invasive portable screening devices; 2) provides faster, more discriminatory assessments in near real-time; 3) yields the most precise and accurate results to identify cancers earlier, when interventions are more impactful, less expensive, less invasive, and more likely to improve patient outcomes.This Small Business Technology Transfer (STTR) Phase I project seeks to establish the feasibility of developing the first portable, programmable, single cell cytology platform for early detection of multiple types of epithelial cancers, suitable for use at the point-of-care. The proposed technology will uniquely combine microfluidics and artificial intelligence (AI) to act as a sensor and provide predictive analysis, allowing for the accurate classification of potentially cancerous tissue. The platform will support near real-time, multiparameter, single-cell cytology measurements and will provide a method for automated analysis of a plurality of key metrics. Proof of concept has been established for the application area of oral cavity cancers, with the approach demonstrating superior performance metrics compared to other diagnostics (tissue reflectance, tissue auto fluorescence, salivary testing, and cytology testing). It is the only adjunct that can distinguish between mild, moderate, and severe dysplasia. The key objectives for this project are to develop methodologies to link different clinical specimen types to the microfluidics environment, and a biomarker discovery process to identify biomarkers for different applications that are amenable to the platform. The successful completion of this project will enable the platform to recognize and assess various levels of dysplasia across multiple epithelial cancer types.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.

这个小企业技术转让（STTR）第一阶段项目的更广泛的影响/商业潜力将解决对一种可获得的方法的需求，以高准确性，更早和更低的成本来识别早期上皮癌。2020年，癌症护理的总成本接近2100亿美元。由于当前癌症诊断的性质，大多数癌症在晚期被诊断和治疗。这对患者、家庭、医疗保健提供者和设施造成了巨大的经济负担。为了促进公众的健康和福利并减少国家的医疗负担，需要非侵入性、成本有效、易于使用和准确的癌症筛查、诊断和监测设备。所提出的用于早期检测多种类型的上皮癌的平台1）解决了缺乏有效的非侵入性便携式筛查设备的问题; 2）提供了近实时的更快、更有区别的评估; 3）产生最精确和准确的结果，以更早地识别癌症，此时干预措施更有效，更便宜，侵入性更小，这个小企业技术转让（STTR）第一阶段项目旨在建立开发第一个便携式、可编程的单细胞细胞学平台的可行性，该平台适用于早期检测多种类型的上皮癌，适用于护理点。这项技术将独特地将联合收割机微流体和人工智能（AI）结合起来，作为传感器并提供预测分析，从而对潜在的癌组织进行准确分类。该平台将支持近实时、多参数、单细胞细胞学测量，并将提供用于多个关键指标的自动化分析的方法。已经为口腔癌的应用领域建立了概念验证，与其他诊断（组织反射率、组织自体荧光、唾液检测和细胞学检测）相比，该方法表现出上级性能指标。它是唯一可以区分轻度、中度和重度发育不良的辅助药物。该项目的主要目标是开发将不同临床标本类型与微流体环境联系起来的方法，以及一个生物标志物发现过程，以识别适用于该平台的不同应用的生物标志物。该项目的成功完成将使该平台能够识别和评估多种上皮癌类型的不同程度的异型增生。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。