Molecular Screening for Human Papilloma Virus (HPV) Associated with Cervical Cancers in LMIC Environments

Abstract Human papillomavirus (HPV) causes cervical cancer, anogenital cancers, and a subset of oropharyngeal cancers, with over 350,000 deaths per year globally. The World Health Organization guidelines for screening of cervical cancer recommend using a strategy of screening with an HPV test instead of cytology or visual inspection with acetic acid (VIA) for women with a priority age 30-49. In many underserved low- and middle- income countries (LMICs), HPV testing may be available in cities but more limited in rural villages without ready access to clinical laboratory facilities, due to cost and logistical barriers. To address this gap, we developed and tested a portable, novel isothermal test called SPRINT-HPV (Simple, Portable, and Rapid Isothermal Nucleic- acid Test) for the simultaneous detection of HPV16, HPV18, and nine other high-risk subtypes from cervical fluid. SPRINT-HPV is specifically designed to be manufactured at a low reagent and equipment cost for point of care (POC) settings. This SBIR Phase I proposal focuses on advancing SPRINT-HPV towards commercialization by ensuring scalable, robust production and validating microfluidic cartridge performance for use in environments without laboratory infrastructure. Scalable production of the SPRINT-HPV system will be engineered by using steel-rule die cutting and injection molding for critical components. Each unit will be rigorously tested for thermal stability, fluorescence detection, and reproducibility. A pilot production of microfluidic cartridges will be used to assess performance of the SPRINT-HPV system with template nucleic acid and lyophilized reagents. Studies will evaluate QA/QC testing, analytical performance, intra- and inter-assay variation, and stability of lyophilized reagents. A pre-submission meeting with the US FDA will be conducted to obtain regulatory feedback for design iteration and commercialization. Future Phase II efforts will focus on expanding QA/QC parameters, transitioning to high-throughput cartridge manufacturing with blister pack fluidics, and conducting large-scale clinical validation. We will aim for FDA and EU regulatory submissions for commercial deployment of SPRINT-HPV to address the global need for cost-effective HPV screening in underserved regions.