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.

宫颈癌护理点 HPV 16/18/45 DNA 检测。 十字生命科技公司 项目概要/摘要 人类宫颈癌是全球女性第四大常见癌症[1]。 尽管宫颈癌已得到彻底研究并且死亡率已 通过有效筛查显着减少，这些预防计划被发现可以 在发展中国家效果较差[2-3]。核酸需求未得到满足 可在护理点应用的新诊断方法来检测 HPV 16/18/45 DNA 宫颈癌。 用于检测宫颈癌的简单、灵敏、多重且强大的检测试剂盒 将开发护理点生物标志物 HPV 16/18/45 DNA。竞争性的 TARA 的优点是利用了具有类似检测功能的新型化学反应 与 Hologic Aptima HPV 16 18/45 基因型检测相比的敏感性和特异性 纸条上的简单读数更适合没有仪器的现场设备。 TARA 还提供了直接检测复杂样品基质的潜力，例如 宫颈样本或血液，无需样本制备。建立在化学和 设备创新（TARAplex 和一维纸网络），我们取得了重大进展 并开始通过我们既定的合作探索整合。 我们的目标是开发一种快速点测试，可在 < 30 天内在需要时检测 HPV 分钟，适合非实验室环境和非技术人员。我们的 专有测试利用新型探针反应化学，可进行多重检测 DNA 或 RNA 无需样品纯化，使其可作为简单的手持式操作 测试。患者样本直接输入设备，无需预处理和 一次性试剂盒对所有目标进行扩增并报告可见结果 可以用肉眼读取。我们预计对美国的敏感性 (>90%) 和特异性 (>90%) 市售 Aptima HPV 16 18/45 基因型测定 (HOLOGIC) 数据 相同的样品。 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以及 首先向非政府组织 (NGO) 推销，例如无医生组织 (Doctors Without) 博德斯或盖茨基金会。我们将在第 3 阶段获得 USFDA 510 K 许可 为了在美国销售我们的产品