Point of Care Technologies for Nutrition, Infection, and Cancer for Global Health (PORTENT)

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1.0 Overall Abstract We propose the establishment of PORTENT – “Point-of-Care Technologies for Nutrition, Infection and Cancer for Global Health” centered at Cornell University in partnership with Columbia and McGill Universities. The recent Lancet Diagnostic Commission report states that the “diagnostic gap is most severe at the level of primary health care, in which only about 19% of populations in low-income and lower-middle-income countries have access to the simplest of diagnostic tests … People who are poor, marginalized, young, or less educated have the least access to diagnostics.” Developing PoC devices for these populations is challenging. The needs are unique, the users have disparate qualifications, the path to commercialization is different, the settings have variable infrastructure, the regulatory agencies have distinctive requirements, and the stakeholders are diverse. The PORTENT Center is unique as it (1) focuses on primary health care globally; (2) addresses the needs of the most vulnerable in the US and internationally; and (3) enables a broad range of diagnostic technologies to be validated on a global scale while simultaneously developing expertise and building capacity internationally to have the most impact even beyond the center. The center builds on our decades of international experience in validation, deployment, and commercialization of POC systems and incorporates clinical validation and satellite technology sites across four continents enabling testing on diverse populations and with a unique set of users. Our approach is fundamentally enabled by 5 key differentiable elements: (1) A rigorous approach to Needs Assessment through the establishment of an annual Global PoC Needs Assessment Consensus developed by a Needs Assessment Advisory Board; (2) The ability to validate PoC technologies on an exceptionally broad range of established populations and biospecimens in New York City, Ecuador, India, and Uganda; (3) The establishment of a “Lab-to-Market accelerator for Global Health Point of Care Technologies” to provide commercialization and tech-to-market support for PORTENT projects; (4) Unique training opportunities and knowledge transfer workshops for healthcare workers in LMICs on the use of PoC devices and clinical rotations at our international sites for PoC developers; (5) Access to the team’s network of industrial partners, diagnostics companies, regulatory experts, venture capital groups, and domestic & international non-governmental organizations. Illustrative of what we will fund through PORTENT, we describe four “Year 1” projects that (1) enable early screening of cervical cancer, (2) determination of iron status enabling anemia screening, (3) combined HIV and multiplexed detection of sexually transmitted diseases, and (4) broader, cheaper, and more accurate malaria testing. By the end of year 5, PORTENT will: initiate 20 independent PoC technology projects (with 30% from outside US), engage ~ 15 teams in the Global Health Lab-to-Market accelerator program, train 30 health care workers from LMICs on use of PoC technologies, and provide >20 clinical rotations for technology developers.