The MedTech Europe blog

Events which force us to confront our limitations are powerful experiences to learn from. They make us change our assumptions and, ultimately, can lead to actions that will impact our world.

The Ebola outbreak of 2014 is showing the existing limitations of health systems around the world. Declared a Public Health Emergency of International Concern by the World Health Organization, by now the Ebola outbreak has claimed over a thousand lives and is yet to be brought under control.

Effectively diagnosing Ebola patients is critical, as, in many diseases, rapid diagnosis followed by treatment increases the survival rate of patients. In the case of Ebola, a fast diagnosis will be critical in curbing the transmission of the disease. In vitro diagnostic testing is the only way to diagnose the disease, as the symptoms of Ebola are not specific: fever, headaches, muscle pain, sore throat…

Shortcomings in diagnostic capacity for Ebola in West Africa, where there has never been an Ebola outbreak, were apparent from the start of the crisis. The WHO, in its recommendations, emphasises the need for diagnostic facilities near the outbreak. This makes for a faster diagnosis of Ebola patients.

Ebola is no longer a concern just for West Africa

However, Ebola is no longer a concern just for West Africa: the WHO after its announcement has recommended that every country needs to have access to diagnostic laboratories capable of diagnosing it, which will require deploying both material and human resources in order to ensure that any case can be adequately detected.

But this Ebola outbreak does provide insights into how diagnostics can help in future health emergencies if adequate preparations are in place.

Incentivise the development of rapid diagnostics – The public health benefit of rapid diagnostics for diseases like Ebola, which are highly infectious and capable of causing outbreaks, is clear. The incentive to develop such rapid tests is not. Handling of these pathogens is complex and not without risk, and the investing R&D resources into developing devices that may never be needed is something that cannot be justified from a purely economic perspective. Therefore, incentives need to be developed so that, when they are needed, rapid diagnostic tests to combat such outbreaks are available.

Deployment – Even when a rapid test has been developed, the question of deployment is critical. Under normal circumstances, maintaining large stocks of tests that will expire before they can be used is not sustainable. Expedited production in the case of an outbreak could be a possible solution. Equally important is being able to get the tests to health workers in affected areas so they can be effectively used.

Safety and results – Special considerations may be needed when designing a rapid test for a pathogen like Ebola in order to ensure the safe handling and disposal of what is potentially a highly infectious sample of a deadly disease. At the same time, it remains critical that the test accurately detects the disease.

It’s not just Ebola – Unfortunately, there are other pathogens with the potential to result in outbreaks. Rapid diagnostic tests should also be developed for them, as any of them could be the root of the next outbreak.

And, while we think of the future, our support goes out to the men and women who are out on the ground today fighting this outbreak. MSF, in particular, deserves our support and admiration for their unrelenting work in this outbreak.

-Jesús Rueda Rodríguez, EDMA, Regulatory Affairs Director

Editors’ note: This post is part 2 of a 3 part series on Ebola Epidemic. Read Part 1 of the series: Ebola Epidemic: Insights from a health expert in the field

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