HPV POINT OF CARE MOLECULAR DIAGNOSTICS FOR LMICS

高收入国家的宫颈癌发病率和死亡率大幅下降，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，全球估计有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（LMIC）。  由于许多发展中国家面临着流行病向慢性病的转变，而且还没有做好准备，宫颈癌死亡率的负担预计将急剧上升，特别是对那些出生贫困的人。在低收入国家，妇女仅仅因为出生地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一个机会，可以最大限度地减少对妇女的不公正待遇。HPV DNA的简单、经济、快速的分子诊断检测可以在中低收入国家中实现有效的“筛查和治疗”癌症预防计划。Phoenix Biosystem与宾夕法尼亚大学的Haim Bau博士合作，建议通过调整Bau博士正在申请的用于HPV病毒载量分析的PENN-RAMP专利技术来开发POC HPV DNA检测。PENN-RAMP技术是一种简单的闭管分子检测，它将RPA和LAMP两种等温检测方法结合在一种检测形式中，灵敏度与PCR相匹配。

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.