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

这个小型企业技术转让(STTR)第一阶段项目的广泛影响/商业潜力将解决对可获得的方法的需求，以识别早期上皮癌，比目前可用的方法更准确、更早、成本更低。2020年，癌症护理的总成本接近2100亿美元。由于目前癌症诊断的性质，大多数癌症都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。为了增进公众的健康和福利，减轻国家的医疗负担，需要非侵入性、高性价比、易用和准确的癌症筛查、诊断和监测设备。拟议的多种上皮性癌症早期检测平台1)解决缺乏有效的非侵入性便携式筛查设备的问题；2)提供更快、更具歧视性的近实时评估；3)在干预措施更有效、更便宜、更具侵入性、更有可能改善患者预后的情况下，更早地识别癌症，从而产生最精确和最准确的结果。这项拟议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性分析，从而能够对潜在的癌症组织进行准确的分类。该平台将支持近实时、多参数、单细胞细胞学测量，并将提供一种对多种关键指标进行自动化分析的方法。口腔癌的应用领域已经建立了概念验证，与其他诊断方法(组织反射率、组织自动荧光、唾液测试和细胞学测试)相比，该方法显示出更好的性能指标。它是唯一能区分轻度、中度和重度不典型增生的附属词。该项目的主要目标是开发将不同的临床标本类型与微流体环境联系起来的方法，以及一个生物标记物发现过程，以确定适用于该平台的不同应用的生物标记物。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。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.