Human papilloma viruses (HPV) are associated with and/or cause a variety of human diseases ranging from benign warts to fatal carcinoma of the cervix. Different HPV types cause different diseases. Certain ones may predict or even cause the progression of benign lesions to cancer. However, due to the lack of inexpensive, accurate tests, these relationships are not clearly understood. A rapid, reliable method to assay the presence and type of HPV would facilitate studies of HPV and related diseases and make screening for HPV practical. A new non-radioactive procedure for labeling nucleic acids has been developed and found to be effective in detecting extremely small quantities of specific DNA bound to filters and in situ on sections of fixed tissue. The procedure is faster, easier, less subject to interference and less costly than current methods. The SBIR Phase I contract would test the feasibility of using this system to detect and type some strains of HPV. A Phase II study would apply this technique to a variety of clinical samples both to begin retrospective studies of the role of HPV in disease, and to determine the usefulness of this procedure in clinical assays.
