Global health diagnostics: research, development and regulation

To highlight the promise of diagnostics, and to discuss barriers to their development, regulation and use in low- and middle-income countries, the Academy held a workshop on the topic of 'Global Health Diagnostics: Research Development and Regulation'.

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To date, efforts to address the burden of infectious diseases in low- and middle-income countries (LMIC) have largely focused on the development and delivery of vaccines and therapeutic interventions, whilst the importance of diagnostics has been comparatively neglected.

As a result, current diagnostic methodologies are often inappropriate to needs and contexts of LMIC, and there remain a number of barriers to the development and delivery of safe, effective and affordable diagnostics. Yet, diagnostics guide the majority of healthcare decisions and the advent of rapid point-of-care diagnostics holds significant promise for addressing the health burden in LMIC.

In order to highlight the promise of diagnostics, and to discuss barriers to their development, regulation and use in LMIC, the Academy held a workshop on the topic of 'Global Health Diagnostics: Research Development and Regulation' on 3 December 2008. The workshop included presentations by leading experts in the field and provided an opportunity to bring together representatives from academia, industry, stakeholders and government for an active and open discussion.

The report highlights challenges and opportunities to research, development and regulation of diagnostics pertinent to LMIC, with a focus on rapid diagnostic tests for infectious diseases. In particular, the report considers: the design and development of diagnostic tests; access to diagnostics; use of diagnostics in practice; regulation and evaluation of diagnostic tests; and challenges and opportunities for the diagnostics industry.

Bringing these themes together, the report highlights the need for capacity strengthening in research and development, a greater focus on the priorities and contexts of LMIC during the design of diagnostics, and a tightening of regulatory requirements - potentially through a World Health Assembly resolution. The report also highlights scope for the development of a single body, involving academia, industry and relevant stakeholders, which could provide leadership and guidance on behalf of the diagnostics community, and contribute to the implementation of regulatory policy.

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