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）的快速护理测试将使医生在常规护理中迅速识别高风险患者，并在宫颈癌和肛门癌筛查和诊断方面执行下一步。所提出的系统建立在下一代分子诊断平台上，该平台在当前测试成本的一小部分中提供高灵敏度和选择性性能，使用市售的测定法，该测定法可以检测15个HRHPV类型，具有针对高风险HPV16和HPV18的特定呼叫。具体目标1涉及将现有HPV测定套件集成和优化到当前墨盒中，并将将分析灵敏度与现有HPV测定法进行比较。 AIM 2将临床性能与现有的FDA批准系统进行比较。 AIM 3比较了患者自我收集到的临床收集的患者拭子的结果。在医生办公室使用拟议的HPV测试系统将为宫颈癌和肛门癌筛查提供更好的测试访问，尤其是在无法访问实验室（例如粗糙或偏远地区）的位置。该系统被设计为CLIA豁免测试，也可以使用子宫颈或肛门患者收集的拭子来实施，从而进一步提高患者的访问，灵活性和HPV筛查的医疗保健成本效益。