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E Ando在宫颈癌和肛门癌筛查和诊断中执行下一步的步骤。当前测试的一部分在高风险的HPV16和HPV18上进行了特定的呼叫类型。 AIM 3指南针从临床医生到临床医生的拭子，阳离子有限的阳离子。由子宫颈或肛门的患者收集，HPV筛查的屈曲率和医疗保健成本效益。