Abstract

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

John McDevitt, Chair, Department of Biomaterials, New York University College of Dentistry Bioengineering Institute

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%, yet when diagnosed in the early stages with confinement to the primary site, the rate increases dramatically to about 83%. Cancers of the oral cavity are among the most expensive to treat due to the fact that approximately 2/3rds 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, the McDevitt laboratory has developed an integrated chip cartridge for use as adjunctive diagnostic aids for the diagnosis of potentially malignant oral lesions. This new approach combines 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 has been 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. These efforts have been validated through major clinical studies involving recruitment of over 1000 patients leading to one of the largest cytology databases related to oral cancer ever created. Through these efforts over 10M single cell cytology measurements have been recorded for over 50 image-based parameters. Extensive model development and model validation has been completed en route to selection of optimal diagnostic models. Strong correlations between the chip-based pathology exams and the adjudicated results from a panel of expert pathologists have been completed for this new ‘cytology on a chip’ approach.