Lab-on-a-Chip-Based System for Detection and Monitoring of Oral Cancer in Dental Settings

用于牙科环境中口腔癌检测和监测的基于芯片实验室的系统

• 批准号: 9047158
• 负责人: JOHN T MCDEVITT
• 金额: $ 22.5万
• 依托单位: SENSODX II, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-01 至 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9047158
• 关键词: Address; Algorithms; American; Area; Automation; Benign; Biological Assay; Biological Markers; Biopsy; Biopsy Specimen; Cancer Patient; Cell Line; Cell surface; Cells; Cellular Phone; Characteristics; Clinical; Clinical Trials; Collection; Color; Computer software; Cyclic GMP; Cytology; Data; Dental; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Factor; Documentation; Elements; Environment; Fostering; Gold; Health; Health Care Costs; Histopathology; Image; Image Analysis; Injection of therapeutic agent; Laboratories; Lesion; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of pharynx; Manuals; Measurement; Mechanics; Methodology; Methods; Microfluidics; Modality; Modeling; Molds; Monitor; Movement; Nuclear; Operative Surgical Procedures; Oral; Pathology; Patient risk; Patients; Performance; Pharyngeal structure; Phase; Positioning Attribute; Process; Production; Protocols documentation; Reporting; Reproducibility; Research Infrastructure; Risk Factors; Sampling; Shipping; Ships; Site; Small Business Innovation Research Grant; Specificity; Specimen; Spottings; Staging; Survival Rate; System; Technology; Test Result; Testing; Time; Training; Validation; Variant; base; cellular imaging; clinical practice; commercialization; design; diagnostic accuracy; digital imaging; disability; follow-up; improved; insight; instrument; instrumentation; mHealth; malignant mouth neoplasm; manufacturing process; meetings; micro-total analysis system; miniaturize; minimally invasive; molecular marker; new technology; novel; novel diagnostics; novel strategies; oral lesion; outcome forecast; photolesion; point of care; programs; prospective; protein expression; prototype; public health relevance; research clinical testing; sample collection; scalpel; screening; single cell analysis; tool

 DESCRIPTION (provided by applicant): Cancers of the oral cavity and pharynx are among the most serious cancers, with approximately 400,000 incidents globally. In the US, the 5-year survival rate is approximately 64% among the lowest for all forms of cancer. Yet when diagnosed in the early stages with confinement to the primary site, the rate increases dramatically to about 83%. Further, cancers of the oral cavity are among the most expensive to treat due to the fact that approximately two-thirds of oral and pharyngeal cancers are advanced at the time of diagnosis. Until now, scalpel biopsy has been the only reliable means of accurately assessing suspicious oral lesions. To address these significant clinical gaps, SensoDx will target the development and commercialization of the OraTechTM technology for use as adjunctive diagnostic aids for the diagnosis of potentially malignant oral lesions. This new approach will combine a noninvasive oral brush sampling methodology, a microfluidic cell capture cartridge, an assay platform and an analyzer system. This state-of-the-art automated miniaturized cytology system will be used to reveal cell morphometrics and protein expression values (cell surface markers and intracellular markers) to identify the patients with a subset of potentially malignant oral lesions that require follow up scalpel biopsy. Diagnostic models based on biomarker data derived from these powerful chip-based tools, alongside lesion characteristics obtained from a customized mHealth App will allow for an elegant data fusion process to occur whereby lesion characteristics, risk factors and the numerous cytology factors yield the desperately needed clinical insights for patients suffering from oral cancer. This Fast Track SBIR submission will include two major segments. In the first phase, the specifications for the scalable cartridges will be defined and protocols established for high reproducibility single cell measurements. Commercial imaging instrumentation and software will also be developed during this time period. In the second major phase, the consumables will be scaled, manufacturing processes will be developed and the instrumentation and cartridges will be validated using banked specimens. The key technical objectives for the effort are as follows: 1. To design and develop unique microfluidics-based cartridges that are suitable for capture and completion of single-cell assays as promoted by a minimally-invasive brush sampling device. 2. To define optimal sample collection and shipping protocols suitable for high quality single cell assays. 3. To establish specifications for the cartridge and to define manufacturing methods that enable volume production of cartridges, analyzer instrumentation, and control-analysis software. 4. To develop a mHealth tool that allows for the seamless pairing of brush biopsy specimens with lesion photos thereby fostering a data fusion that enhances the performance of this noninvasive test modality.

 描述（由申请人提供）：口腔癌和咽癌是最严重的癌症之一，全球约有 400,000 起病例。在美国，5 年生存率约为 64%，是所有癌症中最低的。然而，当在早期阶段诊断并局限于原发部位时，该比率会急剧增加至 83% 左右。此外，口腔癌是治疗最昂贵的癌症之一，因为大约三分之二的口腔癌和咽癌在诊断时已处于晚期。到目前为止，手术刀活检是准确评估可疑口腔病变的唯一可靠手段。为了解决这些重大的临床差距，SensoDx 将致力于 OraTechTM 技术的开发和商业化，以用作诊断潜在恶性口腔病变的辅助诊断工具。这种新方法将结合无创口腔刷采样方法、微流体细胞捕获盒、测定平台和分析系统。这种最先进的自动化小型细胞学系统将用于揭示细胞形态测量和蛋白质表达值（细胞表面标记物和细胞内标记物），以识别患有潜在恶性口腔病变子集、需要后续手术刀活检的患者。基于从这些强大的基于芯片的工具衍生的生物标志物数据的诊断模型，以及从定制的移动医疗应用程序获得的病变特征，将允许发生优雅的数据融合过程，从而病变特征、风险因素和众多细胞学因素为口腔癌患者提供迫切需要的临床见解。此快速通道 SBIR 提交内容将包括两个主要部分。在第一阶段，将定义可扩展卡盒的规格并建立高再现性单细胞测量的协议。商业成像仪器和软件也将在此期间开发。在第二个主要阶段，将扩展消耗品，开发制造工艺，并使用储存的样本验证仪器和墨盒。 这项工作的关键技术目标如下： 1. 设计和开发独特的基于微流体的卡盒，适合捕获和完成微创刷式采样装置所提倡的单细胞测定。 2. 定义适合高质量单细胞测定的最佳样品采集和运输方案。 3. 建立卡盒规格并定义能够批量生产卡盒、分析仪器和控制分析软件的制造方法。 4. 开发一种移动医疗工具，允许刷活检标本与病变照片无缝配对，从而促进数据融合，从而增强这种无创测试方式的性能。