Head and neck cancer remains a challenging disease that is increasing in incidence with the majority of patients diagnosed at an advanced stage where 5-year survival is approximately 50%. Current approaches including oral-brush biopsies, fluorescence-based technologies, and salivary molecular profiling have demonstrated some success; however, cost, ease of use, and accuracy remain limiting factors. Areas covered: This is a profile of a novel, easy to use oral rinse point-of-care (POC) test to aid in the diagnosis of oral and oropharyngeal cancer. Background science related to the challenge of oral and oropharyngeal cancer and natural history of diagnostic aids for this disease are provided. Results of studies performed for validation of a POC and laboratory test are also discussed. Expert commentary: The POC test has been validated through a case : control clinical study and a prospective European trial, using version 1.0 (v1.0), which have demonstrated consistent performance including a > 90% negative predictive value, with a sensitivity of 80%. The assay was designed to identify malignant lesions in the oral cavity and oropharynx by improving upon standard clinical assessment.
Keywords: CD44; early detection; oral cancer; point-of-care; saliva; total protein.