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.

该小企业技术转让 (STTR) 第一阶段项目的更广泛影响/商业潜力将满足对一种可在 2020 年以比目前现有方法更准确、更早且成本更低的方式识别早期上皮癌的需求。由于当前癌症诊断的性质，大多数癌症均已处于晚期阶段，这给患者、家庭、医疗保健提供者和治疗机构带来了巨大的经济负担。为了提高公众的健康和福利并减轻国家的医疗负担，需要非侵入性、经济高效、易于使用且准确的癌症筛查、诊断和监测设备。多种类型上皮癌的早期检测 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、更具辨别力的近实时评估；3) 产生最精确和准确的结果，以更早地识别癌症，当干预影响更大、成本更低、侵入性更小，并且更有可能改善患者的治疗结果。这个小型企业技术转让 (STTR) 第一阶段项目旨在建立开发第一个便携式、可编程、单细胞细胞学平台的可行性，用于早期检测该技术将独特地将微流体和人工智能（AI）结合起来，充当传感器并提供预测分析，从而能够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，并将提供一种用于自动分析多个关键指标的方法，该方法已针对口腔癌的应用领域建立了概念验证，该方法表现出优越的性能。与其他诊断（组织反射、组织自发荧光、唾液检测和细胞学检测）相比，它是唯一可以区分轻度、中度和重度发育不良的辅助方法。连接不同的临床标本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不典型增生。通过使用基金会的智力价值和更广泛的影响审查标准进行评估，NSF 的法定使命被认为值得支持。