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(申请人提供)：口腔和咽部癌症是最严重的癌症之一，全球约有40万例。在美国，五年存活率约为%，是所有癌症中最低的。然而，当在早期诊断为局限于原发部位时，这一比例急剧上升至约83%。此外，口腔癌是治疗费用最高的癌症之一，因为大约三分之二的口腔癌和咽癌在确诊时是晚期的。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将致力于OraTechTM技术的开发和商业化，将其用作诊断潜在恶性口腔病变的辅助诊断工具。这一新方法将结合非侵入性口腔刷子采样方法、微流控细胞捕捉盒、分析平台和分析系统。这一最先进的自动化小型化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)，以识别患有需要后续手术刀活检的一组潜在恶性口腔病变的患者。基于从这些强大的基于芯片的工具获得的生物标记物数据的诊断模型，以及从定制的mHealth App获得的病变特征，将允许进行优雅的数据融合过程，通过该过程，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，并制定用于高重复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，将扩大消耗品的规模，开发制造工艺，并将使用储存的样品验证仪器和墨盒。这项工作的主要技术目标如下：1.设计和开发独特的基于微流控的色谱柱，适用于由微创刷子采样装置推动的单细胞分析的捕获和完成。2.确定适用于高质量单细胞分析的最佳样品采集和运输方案。3.确定试剂盒的规格，并确定能够批量生产试剂盒、分析仪器和控制分析软件的制造方法。4.开发一种mHealth工具，允许将刷检标本与病变照片无缝配对，从而促进数据融合，以增强这种非侵入性测试模式的性能。