Abstract

Abstract 9 Cancer kills more people worldwide than HIV/AIDS, tuberculosis, and malaria combined, and low- and middle-income countries (LMICs) bear the majority of this burden. While success in detection, diagnosis, and treatment has been reported in LMICs through the use of low-cost, point-of-care (POC) technologies, this area has been largely overlooked by the medical device industry and venture capital communities, as low-cost solutions offer less financial incentive for investment. The program presented here aims to simplify the pathway to market by funding investigation teams to adapt and validate existing technologies in low-resource settings. This program specifically supports the translation of these technologies, prioritizing patient outcomes in a manner not typically seen. This program, currently in its second year, will soon support 15 technologies for cancer detection, diagnosis, and treatment (e.g., in vitro assays, imaging devices, ablation devices). It is anticipated that by year seven of the program, at least nine projects will have progressed through optimization, clinical validation, and business planning for dissemination and commercialization. Each project consists of an adaptation phase (two years: $500k total costs/year) and validation phase (three years: $1M total costs/year). Projects are selected through the National Institutes of Health peer review process by a special emphasis panel briefed on the goals of the program. Projects are competitively vetted for Phase II funding based on completion of Phase I milestones. All teams contain expertise in engineering, oncology, and business/manufacturing, uniquely leveraging their devices for success in translation. The seven preliminarily funded projects are making strides in optimization, and the projects range from an LED-based photodynamic therapy device for oral cancer to POC tests for Hepatitis C viral antigen level and viral load detection. This program is funded by the National Cancer Institute and the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: No COIs from the authors.

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