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

这项小企业技术转移（STTR）第一阶段项目的广泛影响/商业潜力将满足对一种可获得的方法的需求，以高精度、更早、更低的成本识别早期上皮性癌症。2020年，癌症治疗的总成本接近2100亿美元。由于目前癌症诊断的性质，大多数癌症是在晚期诊断和治疗的。这给患者、家庭、医疗保健提供者和机构带来了巨大的经济负担。为了促进公众的健康和福利，减少国家的医疗负担，需要一种非侵入性的、具有成本效益的、易于使用和准确的癌症筛查、诊断和监测设备。提出的多种类型上皮癌早期检测平台1)解决了缺乏有效的非侵入性便携式筛查设备的问题；2)近乎实时地提供更快、更具歧视性的评估；3)产生最精确和准确的结果，以便更早地识别癌症，此时干预措施更有效，更便宜，更少侵入性，更有可能改善患者的预后。这个小型企业技术转移（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，用于早期检测多种类型的上皮性癌症，适合在护理点使用。提出的技术将独特地结合微流体和人工智能（AI）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，并将为多个关键指标的自动分析提供一种方法。在口腔癌的应用领域已经建立了概念验证，与其他诊断方法（组织反射、组织自身荧光、唾液检测和细胞学检测）相比，该方法显示出优越的性能指标。它是唯一可以区分轻度、中度和重度发育不良的辅助手段。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，以确定适合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水平的不典型增生。该奖项反映了美国国家科学基金会的法定使命，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。

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.