A RAPID ISOTHERMAL AMPLIFICATION CHIP FOR HPV DETECTION AND GENOTYPING IN LOW-RESOURCE SETTINGS

Cervical cancer is one of the most preventable and treatable forms of cancer, but still the fourth most common cancer in women. To eliminate cervical cancer by 2030, one of the WHO’s targets is to screen 70% of 35 to 45-year old women globally using a high-precision test, such as an HPV test. Approximately 90% of the globe’s 350,000 annual cervical cancer related deaths occur in low- and middle-income countries. These areas are insufficiently equipped with the skilled personnel, well-equipped labs, and technologies available to reach this target with tests currently available on the market. The objective of this project is to develop a point-of-care diagnostic tool to advance near-patient HPV detection and genotyping. We will validate a chip- based, spatial-multiplexed, real-time isothermal amplification assay to detect and genotype high-risk HPV with eventual self-collected swab implementation. A 10-minute process of sample concentration and lysing steps without DNA purification will be optimized. The lysate will then be diluted with water and delivered directly into reaction wells that contain lyophilized master mix for the isothermal amplification in lt 60 minutes. Subcontractor, Professor Jeanne Jordan, a molecular/microbiology expert for infectious diseases at George Washington University will validate our assay at the end of Phase I.