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

DESCRIPTIONprovided by applicantCancers of the oral cavity and pharynx are among the most serious cancerswith approximatelyincidents globallyIn the UStheyear survival rate is approximatelyamong the lowest for all forms of cancerYet when diagnosed in the early stages with confinement to the primary sitethe rate increases dramatically to aboutFurthercancers 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 diagnosisUntil nowscalpel biopsy has been the only reliable means of accurately assessing suspicious oral lesionsTo address these significant clinical gapsSensoDx will target the development and commercialization of the OraTechTM technology for use as adjunctive diagnostic aids for the diagnosis of potentially malignant oral lesionsThis new approach will combine a noninvasive oral brush sampling methodologya microfluidic cell capture cartridgean assay platform and an analyzer systemThis state of the art automated miniaturized cytology system will be used to reveal cell morphometrics and protein expression valuescell surface markers and intracellular markersto identify the patients with a subset of potentially malignant oral lesions that require follow up scalpel biopsyDiagnostic models based on biomarker data derived from these powerful chip based toolsalongside lesion characteristics obtained from a customized mHealth App will allow for an elegant data fusion process to occur whereby lesion characteristicsrisk factors and the numerous cytology factors yield the desperately needed clinical insights for patients suffering from oral cancerThis Fast Track SBIR submission will include two major segmentsIn the first phasethe specifications for the scalable cartridges will be defined and protocols established for high reproducibility single cell measurementsCommercial imaging instrumentation and software will also be developed during this time periodIn the second major phasethe consumables will be scaledmanufacturing processes will be developed and the instrumentation and cartridges will be validated using banked specimensThe key technical objectives for the effort are as followsTo 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 deviceTo define optimal sample collection and shipping protocols suitable for high quality single cell assaysTo establish specifications for the cartridge and to define manufacturing methods that enable volume production of cartridgesanalyzer instrumentationand control analysis softwareTo 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