Point of Care HPV 16/18/45 DNA Test for Cervical Cancer

宫颈癌护理点 HPV 16/18/45 DNA 检测

• 批准号: 10896570
• 负责人: HyunDae Cho
• 金额: $ 99.4万
• 依托单位: CROSSLIFE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10896570
• 关键词: Point; Care; HPV; 16; 18

Point of Care HPV 16/18/45 DNA Test for Cervical Cancer. CrossLife Technologies Inc. Project Summary/Abstract Human cervical cancer is the fourth most common cancer among women worldwide [1]. Despite cervical cancer has been thoroughly studied and the mortality has been significantly reduced through efficient screening, these preventive programs are found to be less effective in developing countries [2-3]. There are unmet needs for nucleic acids new diagnostics that can be applied at the point-of-care to detect HPV 16/18/45 DNA for cervical cancer. A simple, sensitive, multiplex and robust testing kits for detecting cervical cancer biomarker HPV 16/18/45 DNA at the point-of-care will be developed. The competitive advantage of TARA is the utilization of a novel chemical reaction with similar detection sensitivity and specificity compared to the Hologic Aptima HPV 16 18/45 Genotype assay and simple readout on paper-strip more suitable for field devices without an instrument. TARA also offers the potential for direct detection in complex sample matrices, such as cervical sample or blood, without sample preparation. Building on the chemistry and device innovations (TARAplex, and 1D paper network), we have made significant progress and begun to explore integration through our established collaborations. We aim to develop a rapid point-of-test that detects HPV at the point-of-need in < 30 minutes and is appropriate for non-laboratory settings and non-technical personnel. Our proprietary test exploits a novel probe reaction chemistry that allows multiplexed detection of DNA or RNA without sample purification, making it operable as a simple, hand-held test. Patient samples to be input directly into the device without pre-processing and a disposable cartridge carry out amplification of all targets and reports visible results that can be read by eye. We expect a sensitivity (>90%) and specificity (>90%) to the U.S. commercially-available the Aptima HPV 16 18/45 Genotype assay (HOLOGIC) data on the same samples. We will conduct a large-scale validation and obtain World Health Organization (WHO) expedited review approval and recommendation for procurement on our product and market it first to non-governmental organizations (NGO) such as the Doctors Without Borders or the Gates Foundation. We will obtain USFDA 510 K clearance in Phase 3 in order to market our product in the U.S.

宫颈癌的HPV 16/18/45 DNA检测 CrossLife Technologies Inc. 项目总结/摘要 宫颈癌是世界上第四大常见的女性癌症[1]。 尽管子宫颈癌已被彻底研究，死亡率一直是 通过有效的筛查，这些预防计划被发现， 在发展中国家的影响较小[2-3]。对核酸有未满足的需求 新的诊断方法，可以应用在护理点检测HPV 16/18/45 DNA， 宫颈癌 一种用于检测宫颈癌的简单、敏感、多重和稳健的检测试剂盒 将在护理点开发生物标志物HPV 16/18/45 DNA。竞争 塔拉的优点是利用了具有类似检测的新型化学反应 与Hologic Aptima HPV 16 18/45基因型检测试剂盒相比的灵敏度和特异性 并且在纸带上的简单读出更适合于没有仪器的现场设备。 塔拉还提供了直接检测复杂样品基质的可能性，例如 宫颈样本或血液，无需样本制备。在化学和 设备创新（TARAplex和1D纸网络），我们已经取得了重大进展， 取得进展，并开始探索通过我们已建立的合作进行整合。 我们的目标是开发一种快速检测点，可在30分钟内在需要时检测HPV 分钟，适用于非实验室环境和非技术人员。我们 专利测试利用了一种新的探针反应化学，允许多重检测 无需样品纯化，即可进行DNA或RNA的分析，使其可作为一种简单的手持式分析仪进行操作。 test.患者样本直接输入设备，无需预处理， 一次性盒执行所有靶的扩增，并报告可见结果， 可以通过眼睛阅读。我们预计对美国的敏感性（>90%）和特异性（>90%）。 市售Aptima HPV 16 18/45基因型检测试剂盒（HOLOGIC）数据 同样的样品。 我们将进行大规模验证，并获得世界卫生组织（WHO） 加快审查批准和建议采购我们的产品， 首先将其推销给非政府组织，如无医生组织， 边界或盖茨基金会。我们将在第三阶段获得USFDA 510 K许可， 在美国销售我们的产品。