The primary objective of this effort is to provide a methodology for assay of human papillomavirus infection in human cells by utilizing monoclonal antibody technology in the development of an immunocytologic assay. Since human papillomavirus infection has been strongly associated with cervical cancer, as well as precancerous lesions; is considered to be a major health problem in this country and worldwide; and is easily treatable following early diagnosis, the clinical need and usefulness of an objective assay used as an adjunct to Papanicolaou smears, is apparent. The Phase I effort consists of the preparation of bovine papillomavirus proteins as immunogen and the production and initial characterization of monoclonal antibodies to the genus-specific capsid protein of Papillomaviruses from the hyperimmunization of mice. Complete characterization of the monoclonal antibodies and incorporation of them into an objective immunocytochemical assay for the detection of papillomavirus infection in humans is planned for Phase II. The uniqueness of the product derives from the anticipated improvement in sensitivity, specificity, and cost over existing methodologies, and the high likelihood of commercial success is assured by a substantial existing market for early diagnostic techniques for cervical cancer which will grow with increasing public awareness and a better test.
