There are no sensitive in vitro diagnostic tests for the detection of oral dysplasia or carcinoma. Although frank malignancies are more readily diagnosed, there are inconsistencies in the categorizing and diagnosis of what are generally termed premalignant conditions. Immunodiagnosis may prove superior to the current method of subjective evaluation of cellular morphology, not only in terms of speed and sensitivity, but also in objectivity. The development of a cocktail of highly associated squamous cell carcinoma monoclonal antibodies to be used as an immunohistochemical reagent will contribute to the effective diagnosis of oral disease. The long range goal of the research is to produce an immunohistochemical reagent which will: 1) Detect all stages of squamous cell carcinoma as well as all cells within the tumor mass, and 2) Will detect premalignant lesions. Those monoclonals selected in Phase I will be evaluated in a large scale clinical study in Phase II.
