Imagine walking for most of the day to get to the health center nearest your community, carrying your young child who is very ill. When you arrive, the doctor takes a sample from your child to perform a diagnostic test. You then learn that it will take a month or more to receive the results, as only a specialised laboratory can perform the necessary test to obtain a diagnosis. This sort of unnecessary delay can be the difference between life and death. It is still, nevertheless, the reality in many countries, especially in limited resource settings where diagnostic testing is centralised, and most patients live far from testing sites.
There are many high quality tests for the diagnosis of infectious diseases but they are neither accessible nor affordable for many people living in low resource settings. To avoid unnecessary delays in treatment, there is tremendous need in these settings to take simple, easy-to-use tests closer to the patients. In fact it will not be possible to achieve significant health outcomes without them.
A particularly relevant example is HIV/AIDS. The World Health Organization and UNAIDS want to put 15 million HIV positive individuals on treatment by 2015, yet millions of HIV patients in Africa do not have access to a CD4 test to determine if they are eligible for treatment. Diagnostic tests are also not widely available for the diagnosis of HIV in infants, which can substantially improve their chance of survival.
The good news is that companies have developed simple rapid tests for HIV and many other diseases, and that have been especially designed for low resource settings. The bad news is that there are still significant obstacles to getting these innovative, new tests into the markets where they are needed most.
What may be surprising to the general public is that there are no globally agreed and enforced standards for ensuring the quality of diagnostic tests. There is little, if any, transparency with respect to regulation, which leaves developers in the dark about required product standards, product registration as well as appropriate distribution channels to market. Delays become inevitable and the pathway from bench to bedside is fraught with uncertainties and high costs.
A new organization, the International Diagnostics Centre (IDC), has been established at the London School of Hygiene and Tropical Medicine to address these diagnostic barriers. IDC will be both a focal point for information sharing by the global diagnostics community and a global network for diagnostic stakeholders. Launched in November 2012, the IDC is a unique public/private collaboration, creating a new model of working that brings together developers, manufacturers, non-governmental organizations, and national and international bodies. The IDC promotes transparency, shares research, provides training and supports advocacy in order to accelerate the health impact of diagnostics.
In healthcare, access to accurate information is vital. The IDC is a comprehensive information hub, providing a digital platform for information for those working in diagnostic development and commercialization, and toolkits and workshops to promote best practice in the implementation of diagnostics for global health.
Imagine, then, a world where every sick child can be reliably tested in their nearest health center with diagnosis and treatment given the same day. The IDC is bringing stakeholders together globally to achieve this vision – a world where every person has access to the quality diagnostics they need to lead a healthier and happier life.
Dr. Rosanna Peeling
Professor and Chair of Diagnostics Research at the London School of Hygiene & Tropical Medicine
Director and founding board member of the International Diagnostics Centre.