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: 9387924
• 负责人: JOHN T MCDEVITT
• 金额: $ 86.82万
• 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 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9387924
• 关键词: AIDS diagnosis; Address; Advanced Malignant Neoplasm; 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; Custom; Cyclic GMP; Cytology; Data; Dental; Detection; Development; Devices; Diagnosis; Diagnostic; Documentation; Elements; Environment; Fostering; Gold; Health; Health Care Costs; Histopathology; Image; Image Analysis; Injection of therapeutic agent; Lab-On-A-Chips; Laboratories; Lesion; Liquid substance; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of pharynx; Manuals; Measurement; Mechanics; Methodology; Methods; Microfluidics; Modality; Modeling; Molds; Monitor; Movement; Nuclear; Operative Surgical Procedures; Oral; Oral Diagnosis; Pathology; Patient risk; Patients; Performance; Pharyngeal structure; Phase; Plasticizers; Positioning Attribute; Process; Production; Protocols documentation; Reporting; Reproducibility; Research Infrastructure; Risk Factors; Sampling; Shipping; Ships; Site; Small Business Innovation Research Grant; Specificity; Specimen; Spottings; Survival Rate; System; Technology; Test Result; Testing; Time; Training; Validation; Variant; base; cancer diagnosis; cellular imaging; clinical practice; commercialization; design; diagnostic accuracy; digital imaging; disability; follow-up; improved; insight; instrument; instrumentation; mHealth; malignant mouth neoplasm; manufacturing process; meetings; 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（由适用提供）：口腔和咽的癌症是最严重的癌症之一，全球约有40万事件。在美国，所有形式的癌症最低的5年生存率约为64％。然而，当在初级诊断并限制为主要地点时，速率大幅增加到约83％。此外，由于诊断时大约三分之二的口服和生理癌症是进展的，因此口腔的癌症是最昂贵的治疗之一。到目前为止，手术刀活检一直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将针对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辅助工具。这种新方法将结合一种非侵入性的口服刷子采样方法，微流体捕获弹药筒，一个测定平台和分析仪系统。这种最先进的自动微型细胞学系统将用于揭示细胞形态计量学和蛋白质表达值（细胞表面标记和细胞内标记），以鉴定患有可能需要跟踪术术生物术的潜在恶性口腔病变的患者。基于从这些强大的基于CHIP的工具得出的生物标志物数据以及从定制MHealth应用程序获得的病变特征的诊断模型将允许出现优雅的数据融合过程，从而使病变特征，危险因素和众多细胞学因素产生患有口腔癌患者急需的临床见解。这个快速的SBIR提交将包括两个主要部分。在第一阶段，将定义可伸缩墨盒的规格，并为高可重复性单细胞测量建立协议。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，将缩放消耗品，制造工艺将开发，并使用库存标本对仪器和墨盒进行验证。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墨盒，这些墨盒适合通过最小侵入性的刷子采样设备促进的单细胞测定和完成单细胞测定。 2。定义适用于高质量单细胞分析的最佳样品收集和运输协议。 3。建立墨盒的规格并定义制造方法，以实现墨盒，分析仪仪器和控制分析软件的体积生产。 4。开发一种MHealth工具，该工具允许将刷子活检标本与病变照片进行无缝配对，从而促进了数据融合，从而增强了这种无创测试模式的性能。