We have extended of our saliva-based LOC research efforts toward early detection of non-gynecologic cancers, such as oral cancer. Oral cancer is a devastating disease affecting approximately 34,000 Americans each year. Of these individuals, only half will be alive in five years, reflecting one of the highest mortality rates for all major cancers. This high mortality rate is often attributed to the advanced tumor stage of many oral cancers upon initial identification and biopsy. Early detection of oral cancer using the LOC sensor offers new opportunities for diagnosis at an early stage where treatment is most effective and survival rates approach 80%.

To address this clinical need, we have developed a cell-based LOC sensor to detect oral cancer biomarkers, such as the epidermal growth factor receptor (EGFR) whose over-expression is associated with early tumor progression and aggressive cancer behavior. Here, the membrane-based LOC platform is utilized to capture and enrich cells from non-invasive brush cytology specimens, similar in theory to a cervical Pap test. Once captured “on-membrane” immunofluorescent assays reveal the presence and phenotype of interrogated cells via automated microscopy and fluorescent image analysis.  In addition to molecular biomarkers, the LOC sensor evaluates several aspects of each cell’s morphology as found in traditional pathology. Example measurements include cell and nuclear area, shape, homogeneity, and nuclear-to-cytoplasm ratio, which is often elevated in high-risk oral lesions exhibiting epithelial dysplasia. This dual molecular and morphological strategy encompasses a wide range of cancer phenotypes possibly increasing the method’s sensitivity over pathology alone. A small pilot study, in collaboration with the University of Texas Health Science Center Dental School, is currently underway to evaluate the clinical sensitivity and specificity of the LOC sensor for detection of oral cancer and high-risk precancerous lesions. Ultimately, we aim to provide a low cost, early detection device for screening oral cancers that will improve patient prognosis and survival.