PHS 2022-1 TOPIC 440 - CANCER PREVENTION & DIAGNOSIS TECHNOLOGIES FOR LOW-RESOURCE SETTINGS

一项针对高危人类乳头瘤病毒HPV （hrHPV）的快速护理点检测将使医生能够在常规护理中快速识别高风险患者，并在宫颈癌和肛门癌的筛查和诊断中采取下一步措施。该系统建立在新一代分子诊断平台的基础上，该平台提供高灵敏度和选择性性能，而当前测试成本的一小部分，使用商业上可用的检测方法，可以检测15种hrHPV类型，并特定地呼出高风险HPV16和HPV18。特异性目标1涉及将现有HPV检测试剂盒整合和优化到当前试剂盒中，并将比较现有HPV检测的分析灵敏度。目标2将临床表现与现有fda批准的系统进行比较。目的3比较患者自行收集的结果与临床收集的患者拭子结果。在医生办公室使用拟议的HPV检测系统将为宫颈癌和肛门癌筛查提供更好的检测途径，特别是在农村或偏远地区等实验室有限的地区。该系统被设计为CLIA豁免测试，也可以通过使用患者从子宫颈或肛门收集的拭子进行自我收集来实施，进一步增加了患者获得HPV筛查的机会、灵活性和医疗成本效益。

A rapid point of care test for high-risk human papillomavirus HPV (hrHPV) would allow doctors to quickly identify high risk patients during routine care and perform next steps in cervical and anal cancer screening and diagnosis. The proposed system is built on a next-generation molecular diagnostic platform which provides high sensitivity and selectivity performance at a fraction of current testing costs, using a commercially available assay that can detect 15 hrHPV types with specific call-outs for high-risk HPV16 and HPV18. Specific Aim 1 involves the integration and optimization of the existing HPV assay kit into the current cartridge, and will compare analytical sensitivity to an existing HPV assay. Aim 2 compares clinical performance to an existing FDA-approved system. Aim 3 compares results from patient self-collected to clinician-collected patient swabs. Use of the proposed HPV test system at a doctor’s office will provide better test access for cervical and anal cancer screening, especially in locations with limited access to laboratories such as rural or remote areas. The system is designed as a CLIA Waived test, and can also be implemented through self-collection using swabs collected by patients from the cervix or anus, further increasing patient access, flexibility and healthcare cost-effectiveness of HPV screening.