Rapid and Affordable Point-of-Care HPV Diagnostics for Cervical Cancer Control

Fast-Track proposals will be accepted. Direct-to-Phase II proposals will be accepted. Only Direct-to-Phase II and Fast-Track proposals will be accepted. Phase I proposals will NOT be accepted. Number of anticipated awards: 3-5 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary Cervical cancer is the fourth most common cancer in women. When pre-cancer or cancer is diagnosed early, cervical cancer is one of the most preventable or treatable forms of cancer. Cervical cancer has become a cancer that defines global health disparity populations based on inequities in the feasibility of delivering effective, but complex and costly screening programs based on cytology and colposcopic diagnosis in low-resource settings. Because of this, the World Health Organization (WHO) Cervical Cancer Elimination strategy calls for screening the majority of women with a high-performance HPV test twice in their lifetime. Realization of that goal using current commercial HPV tests is unlikely. To realize cervical cancer screening elimination goals in low-resource settings, it is essential that new tests can be performed and analyzed outside of traditional healthcare settings and are at a price point that is affordable to enable scalability. Fortunately, emerging test chemistries, including those based on isothermal amplification of HPV DNA, have shown significant promise for the design of highly accurate HPV diagnostics at a lower cost than existing tests. Recent developments in microfluidics, microfabrication, and hand-held computers further improve the prospects for adaptation of accurate, low-cost point-of-care versions of existing lab-based assays. The overarching goal of the work to be supported by this initiative is to bring new alternatives for HPV testing to the market that are, both in a form factor as well as price point, will enable self-testing programs to be established globally at point-ofcare or near point-of-care. This topic is aligned with the Cancer Moonshot Blue Ribbon Panel recommendation to expand the use of proven cancer prevention and early detection strategies (G)