Discrete Assay for Integrated HPV DNA in Cervical Cells

描述（由申请人提供）： 人乳头瘤病毒（HPV）是宫颈癌的主要病因。 癌虽然可以可靠地检测HPV的检测方法是可用的，但其 预测宫颈癌进展的预后价值 有争议的，强调需要测定具有改善的预后 值第二阶段SBIR将开发一种新的方法，用于检测集成 宫颈细胞HPV DNA致癌性HPV DNA整合到宿主基因组中 在宫颈癌和发育不良中常见， 以该事件为目标可能具有很高的临床价值。检测整合的HPV 然而，DNA由于游离型病毒的频繁共存而变得复杂。 DNA.使用含有附加型和整合型HPV的模型细胞系 DNA，以及原位杂交和PCR等分析方法，I期 研究成功检测到整合的HPV DNA。第二阶段研究将 优化该方法以用于临床样品和当前的基于液体的 细胞学方法。与传统的HPV检测相反， 类型，该检测试剂盒检测病毒整合，并针对更广泛的病毒 类型，提高检测灵敏度。 拟议的商业应用： 这种筛查宫颈细胞中整合的HPV DNA的方法将有助于宫颈癌的诊断和早期治疗，降低死亡率。

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.