Discrete Assay for Integrated HPV DNA in Cervical Cells

描述(由申请人提供)： 人类乳头瘤病毒(HPV)被认为是导致宫颈病变的主要原因 癌症。尽管有可靠检测HPV的检测方法可用，但他们的 预测宫颈癌进展的预后价值仍然存在 有争议，强调了改善预后的分析的必要性 价值。这一第二阶段的SBIR将开发一种新的方法来检测集成 宫颈细胞中的HPVDNA。致癌HPV DNA整合到宿主基因组中 在宫颈癌和不典型增生中常见，并检测 靶向这一事件可能具有很高的临床价值。整合型人乳头瘤病毒的检测 然而，dna却因异体病毒的频繁共存而变得复杂。 DNA使用同时包含上体型和整合型HPV的模型细胞系 DNA和分析方法，如原位杂交和聚合酶链式反应，I期 研究成功检测到整合的HPV DNA。第二阶段研究将 优化此方法以用于临床样本和当前基于液体的 细胞学方法。与传统的HPV检测不同，传统的HPV检测会识别病毒 类型，这种检测方法检测病毒的整合并针对更广泛的病毒 类型，提高了检测的灵敏度。 建议的商业应用： 这种宫颈细胞中整合HPV DNA的筛查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.