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，这在很大程度上是因为有效的人类乳头瘤病毒(HPV)疫苗接种和筛查计划。然而，2018年，全球估计有57万 000病例和311 000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向慢性病的流行病学过渡，而且还没有准备好面对它，宫颈癌死亡率的负担预计将大幅上升，特别是对那些出生在贫困中的人来说。提供负担得起的人乳头瘤病毒筛查检查，可以最大限度地减少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的不公正现象。对HPV DNA进行简单、经济、快速的分子诊断测试可以在LMICs中实现有效的“筛查和治疗”癌症预防计划。菲尼克斯生物系统公司与宾夕法尼亚大学的Him Bau博士合作，提议通过采用Bau博士正在申请专利的Penn-Ramp技术来进行HPV病毒载量分析，从而开发POC HPV DNA测试。Penn-RAMP技术是一种简单的闭管分子测试，它将RPA和LAMP两种等温分析结合在一种分析格式中，灵敏度与PCR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.