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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

基本信息

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
项目类别：
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

项目摘要

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.