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

PHS 2022-1 主题 440 - 癌症预防

• 批准号: 10707833
• 负责人: NANCY SCHOENBRUNNER
• 金额: $ 40万
• 依托单位: AMPLIFIDX INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-16 至 2023-09-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10707833
• 关键词: Anus; Area; Biological Assay; Cervix Uteri; Clinical; Collection; Diagnosis; FDA approved; Genotype; HPV-High Risk; Health Care Costs; Human Papillomavirus; Human papillomavirus 16; Human papillomavirus 18; Laboratories; Location; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Patients; Performance; Resource-limited setting; Rural; Screening for cancer; Specimen; Swab; System; Technology; Testing; cancer diagnosis; cancer prevention; cost; cost effectiveness; design; diagnostic platform; flexibility; high risk; molecular diagnostics; next generation; point of care testing; routine care; screening; standard of care; testing access

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.

高危人乳头瘤病毒HPV(HrHPV)的快速护理点检测将使医生能够在常规护理期间快速识别高危患者，并在宫颈癌和肛门癌筛查和诊断中执行下一步。建议的系统建立在新一代分子诊断平台的基础上，该平台以当前测试成本的一小部分提供高灵敏度和选择性性能，使用商业上可用的检测方法，可以检测具有高危HPV16和HPV18特定提示的15种hrHPV类型。具体目标1涉及将现有的HPV检测试剂盒整合和优化到当前的试剂盒中，并将分析灵敏度与现有的HPV检测进行比较。目标2将临床表现与现有的FDA批准的系统进行比较。目的3比较患者自己采集的拭子与临床医生采集的拭子结果。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准入有限的地方。该系统被设计为CLIA豁免测试，也可以通过使用患者从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筛查的灵活性和医疗成本效益。