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HPV16/18/45DNA检测。 CrossLife Technologies Inc. 项目摘要/摘要 人类宫颈癌是全世界妇女中第四常见的癌症[1]。 尽管宫颈癌已经得到了彻底的研究，死亡率也一直在上升 通过有效的筛查显著减少，这些预防计划被发现 在发展中国家不那么有效[2-3]。对核酸的需求还未得到满足 可在护理地点应用的新诊断方法，用于检测HPV16/18/45DNA 宫颈癌。 一种简便、灵敏、多功能、坚固耐用的宫颈癌检测试剂盒 将开发生物标记物HPV16/18/45DNA在护理点。有竞争力的 TARA的优点是利用了一种新的化学反应，具有类似的检测 人乳头瘤病毒1618/45型检测的敏感性和特异性 和简单的纸条读数，更适合于无仪器的现场设备。 Tara还提供了在复杂样本矩阵中直接检测的潜力，例如 宫颈样本或血液，不需制样。以化学和化学为基础 设备创新(TARAplex和1D纸质网络)，我们取得了重大进展 取得了进展，并开始通过我们已建立的合作来探索整合。 我们的目标是开发一种快速检测点，在需要的时候检测HPV。 会议纪要，适用于非实验室环境和非技术人员。我们的 专有测试利用了一种新的探针反应化学，允许多路检测 不需要样品纯化的DNA或RNA，使其可以作为简单的手持设备进行操作 测试。将患者样本直接输入到设备中，而无需进行前处理和 一次性墨盒对所有目标进行放大并报告可见结果， 可以用肉眼看懂。我们预计对美国的敏感性(&gt；90%)和特异性(&gt；90%)。 Aptima HPV 16 18/45基因型别分析(HOLOGIC)数据已上市 同样的样本。 我们将进行大规模验证，并获得世界卫生组织(WHO) 加快对我们产品和产品的采购的审查、批准和建议 首先向非政府组织(NGO)推销它，如无国界医生组织 边界组织或盖茨基金会。我们将在#年第三阶段获得美国食品和药物管理局510 K许可 为了在美国销售我们的产品。