Abstract 1428: The program for cancer detection, diagnosis, and treatment technologies for global health: Translating affordable, minimally invasive point-of-care technologies to less-resourced settings

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. Success in detection, diagnosis and treatment has been reported in LMICs through the use of low-cost point-of-care (POC) technologies, and the program presented offers a unique pathway to this POC market by funding multidisciplinary investigative teams to adapt and clinically validate existing technologies for cancer detection, diagnosis and treatment in low-resource settings. Each project consists of an adaptation phase (2 years: $500k total costs/year) and validation phase (3 years: $1M total costs/year). Projects are selected through NIH peer review process by a carefully-selected 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. The program currently supports seven technologies for cancer detection, diagnosis and treatment, each of which is progressing towards experimental and clinical validation. The first project is an LED-based photodynamic therapy device for oral cancer, that has similar efficacy in vivo and ex vivo as existing laser phototherapy. Another supported project is an automated high resolution microendoscope for cervical cancer detection, with an impressive histological concordance in detecting CIN2/3 (90%+ for CIN3). Two cervical cancer cryotherapy projects are funded: a cryopen, that can achieve an approximately 4.0 mm depth of necrosis (>90% of disease) for cervical cancer treatment, and an efficient cryopop device that consumes less than 10% of CO2, compared to commercially-available devices and exhibits comparable therapeutic efficacy in ballistic gel studies. The program is also supporting two POC tests, a HPV test and a Hepatitis C viral antigen level and viral load detection. Additionally, a breast cancer triaging device/algorithm, with 95% sensitivity and capabilities to reduce false positive detection rate by 40%, is also being supported. Each project has its own detailed outline for Phase I and Phase II studies, which will be highlighting in our presentation. The program is in the process of adding another six projects, and 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 commercialization and field/clinic dissemination. Through these process, we