HPV POINT OF CARE MOLECULAR DIAGNOSTICS FOR LMICS

适用于 LMICS 的 HPV 护理点分子诊断

• 批准号: 10707835
• 负责人: KHALID MOUNZIH
• 金额: $ 38.2万
• 依托单位: PHOENIX BIOSYSTEM, 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/10707835
• 关键词: Biological Assay; Birth Place; Cessation of life; Characteristics; Chemicals; Chronic Disease; Clinical; Collaborations; Country; DNA; Eating; Epidemiology; FDA approved; Face; Genotype; Heating; Human Papilloma Virus Vaccination; Human Papillomavirus; Human papillomavirus 16; Immunization Programs; Incidence; Income; Lead; Legal patent; Low income; Malignant neoplasm of cervix uteri; Measures; Methods; Molecular; Molecular Diagnostic Testing; Pennsylvania; Performance; Poverty; Prevention program; Reproducibility; Sampling; Sensitivity and Specificity; Technology; Testing; Tube; Universities; Viral Load result; Woman; cancer prevention; cost effective; detection limit; field study; instrument; low and middle-income countries; low income country; molecular diagnostics; mortality; phase change; point of care; screening; screening program

Cervical cancer incidence and mortality have plummeted in high-income countries, largely because of effective human papillomavirus (HPV) vaccination and screening programs. However, in 2018, there were an estimated 570 000 cases and 311 000 deaths worldwide, approximately 90% of which occurred in low-income and middle-income countries (LMIC). As much of the developing world faces an epidemiological transition towards chronic disease and is not ready to face it, the burden of cervical cancer mortality is expected to rise dramatically, particularly for those born in poverty. An opportunity to minimize the injustice of women in low-income countries having a substantially increased likelihood of dying from cervical cancer simply because of their place of birth can be found in the provision of affordable HPV screening tests. Simple, cost effective, rapid molecular diagnostic testing for HPV DNA could lead to effective “screen-and-treat” cancer prevention program in LMICs. Phoenix Biosystem in collaboration with Dr. Haim Bau of University of Pennsylvania proposes to develop POC HPV DNA test by adapting Dr. Bau’s patent pending PENN-RAMP technology for HPV viral load analysis. The PENN-RAMP technology is a simple closed-tube molecular test that combines two isothermal assays, RPA and LAMP in a single assay format with sensitivities matching PCR.

在高收入国家，宫颈癌的发病率和死亡率大幅下降，这主要是因为有效的人乳头瘤病毒（HPV）疫苗接种和筛查计划。然而，2018年，全世界估计有57万例病例和31.1万例死亡，其中约90%发生在低收入和中等收入国家。由于许多发展中国家面临着流行病向慢性病的转变，而且还没有准备好面对这一转变，预计宫颈癌死亡率的负担将急剧上升，特别是对那些出生在贫困中的人来说。低收入国家的妇女由于出生地点而死于宫颈癌的可能性大大增加，提供负担得起的人乳头瘤病毒筛查检测是最大限度地减少这种不公正现象的一个机会。对HPV DNA进行简单、经济、快速的分子诊断测试，可能会在中低收入国家导致有效的“筛查和治疗”癌症预防计划。凤凰生物系统公司与宾夕法尼亚大学的Haim Bau博士合作，提出通过采用Bau博士正在申请专利的用于HPV病毒载量分析的PENN-RAMP技术，开发POC HPV DNA检测。PENN-RAMP技术是一种简单的闭管分子测试，结合了两种等温分析，RPA和LAMP在一个单一的分析格式与灵敏度匹配PCR。