Discrete Assay for Integrated HPV DNA in Cervical Cells

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DESCRIPTION (provided by applicant): Human papillomavirus (HPV) is implicated as the primary cause of cervical cancer. Although assays that reliably detect HPV are available, their prognostic value for predicting progression to cervical cancer remains controversial, underscoring the need for assays with improved prognostic value. This Phase II SBIR will develop a novel method for detecting integrated HPV DNA in cervical cells. Oncogenic HPV DNA integration into the host genome is a common occurrence in cervical cancers and dysplasias, and assays targeting this event may have high clinical value. Detection of integrated HPV DNA, however, is complicated by the frequent co-existence of episomal viral DNA. Using model cell lines which contain both episomal and integrated HPV DNA, and analytical methods such as in situ hybridization and PCR, Phase I research successfully detected integrated HPV DNA. Phase II research will optimize this approach for use with clinical samples and current liquid-based cytology methods. In contrast to conventional HPV tests, which identify viral types, this assay detects viral integration and targets a wider range of viral types, increasing assay sensitivity. PROPOSED COMMERCIAL APPLICATIONS: This screening method for integrated HPV DNA in cervical cells will facilitate diagnosis of cervical cancer and early treatment, reducing mortality rates.