Abstract

Non-Communicable Diseases in Global Health Settings – New Opportunities, True Value and Proper Valuation of Point-of-Care Diagnostics

Bernhard Weigl, Director, Center for In-Vitro Diagnostics, Intellectual Ventures/Global Good

The emergence of point-of-care (POC) diagnostics specifically designed for low-resource settings (LRS) coupled with the rapid increase in need for routine care of patients with chronic diseases should prompt reconsideration of how health care can be delivered most beneficially and cost-effectively in developing countries as well as in non-traditional and home care settings in developed countries. Bolstering support for primary care in LRS to provide rapid and appropriate integrated acute and chronic care screening, diagnosis, and treatment may be a possible solution. POC diagnostics can empower local and primary care providers and enable them to make better clinical decisions. This talk explores the opportunity for POC diagnostics to strengthen primary care and chronic disease diagnosis and management in a low resource setting (LRS) to deliver appropriate, consistent, and integrated care, as well as present examples of diagnostic technologies for diabetes and other chronic conditions that are targeted to those settings. We analyze the requirements of resource appropriate chronic disease care, the characteristics of POC diagnostics in LRS versus the developed world, the many roles of diagnostics in the care continuum in LRS, and the process and economics of developing LRS-compatible POC diagnostics. Further, while several different frameworks for evaluating diagnostic tests have been proposed, practically all diagnostics evaluations, especially those looked at by gatekeepers such as regulatory agencies, focus almost exclusively on clinical sensitivity and specificity. Since these parameters are what is being “evaluated” this also ends up what is being “valued” in diagnostics – hence that is what is being optimized by assay developers and commercializers. We believe that there is a need for an expanded understanding and evaluating of medical tests that makes explicit the attributes of tests needed to fully evaluate them, and proposes a simultaneous rather than linear