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

基本信息

批准号：
10010422
负责人：
HyunDae Cho
金额：
$ 29.99万
依托单位：
CROSSLIFE TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-01 至 2022-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10010422
关键词：
Achievement Biological Assay Biosensor Blood Buffers Cervical Cervical Cancer Screening Chemistry Clinical Collaborations Complex DNA DNA Viruses DNA purification Data Data Set Detection Developing Countries Devices Diagnostic Engineering Evaluation Eye Failure Foundations Genotype Goals HPV-High Risk Hand Human Human Papillomavirus Human Resources Human papilloma virus infection Human papillomavirus 16 Infection Infection Control Intervention Laboratories Letters Ligation Liquid substance Malignant Neoplasms Malignant neoplasm of cervix uteri Medical Microfluidics Molecular Nongovernmental Organizations Nucleic Acids Organism Outcome Measure Paper Patients Performance Phase Preparation Preventive RNA Reaction Recommendation Reporting Reproducibility Saliva Sampling Sensitivity and Specificity Specificity Swab Technology Temperature Testing Time Training United States Food and Drug Administration Universities Urine Validation Washington Woman Work World Health Organization amplification detection base cancer biomarkers chemical reaction cost cost effective cross reactivity design expedited review experimental study innovation instrument low and middle-income countries mortality multiplex detection novel novel diagnostics nucleic acid detection nucleic acid purification operation pathogen phase 1 designs phase 2 testing point of care programs prospective test screening

项目摘要

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