Invasive carcinoma of the cervix is one of the most common cancers in the world. Human papillomavirus (HPV), progressing through cervical intraepithelial neoplasia, is the primary causal agent for the development of invasive cervical cancer. However, of the 70 or more HPV subtypes, few progress to cancer. Although early detection coupled with eradication of cervical cancer precursors has been shown to lead to a decreased incidence of invasive cervical cancer, the present state of the art employs diagnostic techniques that are too costly or too time consuming to screen large populations efficiently. Accurate HPV strain identification is presently only possible through cumbersome DNA hybridization analysis utilizing either Southern blot technology or in situ hybridization technology. In the following proposal, an enzyme- assisted, sequence-specific identification system will be developed. The simple, rapid, sensitive, accurate, and low-cost DNA diagnostic system described herein will detect HPV at very early stages of infection and will distinguish between low oncogenic risk strains and high oncogenic risk strains. This will enable large scale screening by establishing a diagnostic protocol that is sensitive, rapid, and relatively inexpensive. The diagnostic tool described by this proposal is also applicable to detection of other infectious diseases and genetic diseases with only minor modifications.
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