The use of appropriate point-of-care (POC) diagnostic tests can mean the difference between the right treatment or continued sickness or death: In low-resource settings (LRS), especially in developing countries, diagnostic capabilities are minimal, inadequate, or nonexistent. New and innovative POC diagnostic technologies designed specifically for LRS will have a major impact on global public health by: providing timely and appropriate patient treatment, reducing over-prescription of drugs, restraining the spread of drug resistance and raising early alerts of a potential pandemic disease. Emerging technologies in diagnostics offer the opportunity to address many of the clinical unmet needs in LRS. PATH, an international leader in the development of affordable and appropriate diagnostic tests, and its partners are proposing a Center to Advance Point-of-Care Diagnostics for Global Health (the Center). Over the course of five years, the Center will accelerate the development and deployment of POC diagnostic tests essential to LRS by: conducting laboratory- and field-based clinical evaluation of up to five selected prototype POC diagnostic tests (Core 1);identifying and selecting up to four innovative and promising technologies for potential development as POC diagnostic tests (Core 2);conducting assessments of the critical clinical needs related to POC diagnostics in relevant resource-limited settings (Core 3);offering a rigorous training program to educate technology developers and researchers, scientists, and engineers, including those from private-sector companies, on the realities of providing health care in LRS (Core 4);and lastly by coordinating activities through a strong, integrated management team and with the required institutional support (technical, facilities, administrative, financial, legal, and logistical) (Core 5). Through training and generation of manuals, tutorials, and standard operating procedures for the activities of all cores, and rigorous plans for dissemination of needs assessment and research, the Center will have an impact beyond its five-year duration. Managed by PATH, with collaboration from the University of Washington (UW) Department of Global Health as the lead on the training core, the Center will play a central role in accelerating the development and introduction of diagnostic tests for use at the POC. PATH'S unique and extensive experience in working with public- and private-sector partners at all stages of the product development, field testing, and introduction process, together with the UW's experience in training in LRS, provide the ideal support for the project's ultimate goal: to improve health among underserved populations worldwide by increasing the availability, accessibility, and affordability of essential POC diagnostic tests.

National Institute of Health (NIH)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Specialized Center--Cooperative Agreements (U54)
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Special Emphasis Panel (ZEB1)
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