A workshop report by the Academy of Medical Sciences calls for a greater focus on the role of diagnostic tests in addressing the burden of disease in low- and middle-income countries.

Current approaches have largely focussed on drugs and treatments, while the value of diagnostics has been overlooked. The Academy report, which summarises the issues raised at a workshop on 'Global health diagnostics: research, development and regulation', highlights that the deployment of safe, accurate and affordable diagnostic tests could revolutionise the diagnosis, monitoring and treatment of disease globally.

Professor Sir Andy Haines FMedSci, Director of the London School of Hygiene & Tropical Medicine and Chair of the Academy workshop said, 'This report addresses an issue which has all too often been neglected by policymakers, research funding bodies and researchers compared with drugs and vaccines. As effective drugs become more widely available to low income populations, the need for accurate diagnosis becomes paramount to ensure that vital medicines are not used inappropriately resulting in drug resistance, wasted resources and unnecessary side effects.'

Many diagnostic tests are developed in high-income countries, and are inappropriate to local needs and contexts in poorer parts of the world. Tests are often prohibitively expensive, or they require skilled personnel or equipment - some tests do not give accurate results at temperatures above 30degC. Most tests for HIV are optimised for virus subtypes that are prevalent in the USA and Europe, whereas HIV subtypes vary markedly in Africa.

For many diseases it can be cheaper to prescribe drugs based on symptoms, rather than run a diagnostic test that requires days or weeks for a result. This prevents treatment for infections without symptoms, including many sexually transmitted infections, which can lead to long-term complications and increases the risk of transmission. Without diagnostic testing, there is a greater risk of misdiagnosis and unnecessary treatment with costly drugs. This wastes resources and contributes to an increase in drug resistant disease strains.

The report recommends steps for: capacity strengthening in research and development in diagnostics; 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.

Professor Robert Souhami CBE FMedSci, Foreign Secretary of the Academy of Medical Sciences, said, 'The lack of regulation enables counterfeit and ineffective tests to reach the market in many low and middle income countries, and there is no requirement for manufacturers to provide data detailing the sensitivity of their tests. The limited size of the diagnostics market, and the large number of ineffective tests in circulation in these parts of the world, are discouraging reputable companies from investing in the development of novel diagnostics.'

Attendees at the Academy workshop called for the development of a single body that represents researchers, clinicians, industry, funders, charities and stakeholders, which acts on behalf of the diagnostics research and development community, and holds responsibility for the implementation of regulatory policy and advocacy.

Academy of Medical Sciences

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