75N91022C00058

Small Business Innovation Research Program (SBIR) Phase I

HPV POINT OF CARE MOLECULAR DIAGNOSTICS FOR LMICS

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.

The goal of phase I is to establish the technical merit, feasibility, and commercial potential of proposed R&D efforts and determine the quality of performance of the small business awardee organization.

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75N91022C00058

PHS-2022-1

Kumar Subramanian