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.
Public Health Relevance Statement: Public Health Relevance: Despite significant advances in surgical procedures and treatment, long-term prognosis for patients with oral cancer remains poor, with 5-year survival rate at approximately 50%, among the lowest for all major cancers. Oral cancer remains one of the most deadly and most expensive cancers to treat. When detected early, the prognosis for oral cancer patients is excellent with more than 90% five-year survival. This SBIR Fast Track application seeks to shift the current clinical practice paradigm for screening and diagnosis of potentially malignant oral lesions by moving away from the sole reliance on invasive scalpel biopsies followed by expensive and time consuming pathology exams to a new paradigm whereby noninvasive brush biopsies are combined with a state-of-the-art `cytology-on-a-chip' system for on the spot analysis of samples. This new technology will afford for the first time single cell analysis of cytology specimens at the point-of-care. These powerful chip-based tools, along with new diagnostic models, have strong promise to improve the way screening and diagnosis of oral cancer is completed on a global basis. The SensoDX OraTechTM sampling device and integrated OraTechTM cartridge together are projected to form the first effective adjunctive diagnostic aid capable of management of malignant and potentially malignant oral lesions on a rapid time frame with high sensitivity and high specificity. 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.
NIH Spending Category: Bioengineering; Biotechnology; Cancer; Dental/Oral and Craniofacial Disease; Digestive Diseases; Networking and Information Technology R&D; Prevention; Rare Diseases
Project Terms: Address; Algorithms; American; Area; Automation; base; Benign; Biological Assay; Biological Markers; Biopsy; Biopsy Specimen; Cancer Patient; Cell Line; Cell surface; Cells; cellular imaging; Cellular Phone; Characteristics; Clinical; clinical practice; Clinical Trials; Collection; Color; commercialization; Computer software; Cyclic GMP; Cytology; Data; Dental; design; Detection; Development; Devices; Diagnosis; Diagnostic; diagnostic accuracy; Diagnostic Factor; digital imaging; disability; Documentation; Elements; Environment; follow-up; Fostering; Gold; Health; Health Care Costs; Histopathology; Image; Image Analysis; improved; Injection of therapeutic agent; insight; instrument; instrumentation; Laboratories; Lesion; Malignant - descriptor; malignant mouth neoplasm; Malignant neoplasm of pharynx; Malignant Neoplasms; Manuals; manufacturing process; Measurement; Mechanics; meetings; Methodology; Methods; mHealth; micro-total analysis system; Microfluidics; miniaturize; minimally invasive; Modality; Modeling; Molds; molecular marker; Monitor; Movement; new technology; novel; novel diagnostics; novel strategies; Nuclear; Operative Surgical Procedures; Oral; oral lesion; outcome forecast; Pathology; Patient risk; Patients; Performance; Pharyngeal structure; Phase; photolesion; point of care; Positioning Attribute; Process; Production; programs; prospective; protein expression; Protocols documentation; prototype; public health relevance; Reporting; Reproducibility; research clinical testing; Research Infrastructure; Risk Factors; sample collection; Sampling; scalpel; screening; Shipping; Ships; single cell analysis; Site; Small Business Innovation Research Grant; Specificity; Specimen; Spottings; Staging; Survival Rate; System; Technology; Test Result; Testing; Time; tool; Training; Validation; Variant
