In the current COVID-19 pandemic, the need for rapid diagnostic tests (RTDs) has become very urgent. Can you tell us about your current research project AdjustEBOVGP-Dx?

Misaki Wayengera (MW): Never before have we had such a huge demand for testing as in the short period of the COVID19 pandemic. The demand for the WHO-accredited (reverse transcription-polymerase chain reaction) test kits is so huge that it ceased to be about the ability to pay, supply is simply limited. This gap can only be met with cheap and easy-to-produce rapid diagnostic tests.

The need for affordable, rapid, easy-to-use tests that can be deployed at the point of care is the same across viral haemorrhagic fevers (VHF) epidemics and the on-going global COVID19 pandemic. Our rationale for embarking on the development of a rapid diagnostic test, Panfilovirus RDT^®, detecting all species of Ebola and Marburg viruses, was largely inspired by the fact that the outbreaks of VHF started in remote equatorial African settings. There was no laboratory capacity to detect the bugs.

In 2007, therefore, we started studying filovirus genomes and proteomes, to identify epitopes that we could advance into an RTD for filoviruses. In 2012, Grand Challenges Canada awarded us seed funding, through their Stars in Global Health Programme. Before we could file our end-of-project report for this phase, the 2013-2016 Ebola virus disease outbreak in West Africa peaked. In August 2014, Grand Challenges Canada (GCC) reached out to us requesting preliminary data. These were successfully evaluated by the independent global diagnostics R&D monitoring firm, Halteres LLC, in California, USA. They also visited our facilities.

That is how we got fast-tracked funding for transition-to-scale. A major bottleneck was the requirement for matching funding (US$1 million). When the Ugandan government did not come through, GCC went on to invest in us anyway. After a US$1 million investment, the test did not work. You can understand our disappointment. It took us a lot of troubleshooting before we thought of a solution. That is when we sought EDCTP funding, first through the fellowship, then also via the ADJUSTEBOVGP-Dx project, that developed a solution that made the epitopes detectable with our diagnostic test. The prototypes developed under this project finally won us the WHO AFRO Innovation prize.

Dr Misaki Wayengera

Global partnerships and ecosystems are key to success. While we had the initial aha moment of insight, it has taken us many partnerships across academia, industry and private-public partnerships to get to the result. Interregional funding such as from EDCTP enables the building of teams that can respond rapidly to future situations.

The AdjustEBOVGP-Dx Consortium brings together two African institutions: Makerere University in Uganda and the National Institute for Communicable Diseases (NICD) in South Africa. The EDCTP career development fellowship helped me do my post-doctoral studies in filovirology at the P4 laboratory of the NICD. I was also training two master’s students. These two are now PhD candidates, who do much of the benchwork that validates reagents before we take them to the lateral flow test platform.

And the consortium has four EU partners: Prof. Dimitrios Vlachakis at the Agricultural University of Athens, Greece; Prof. Dariusz Plewcynzski at the University of Warsaw, Poland; Prof. Erik Bongcam-Rudloff at the Swedish Agricultural University, Sweden; and Dr Fabien Jovelin at GeneCUST, France. The last company is in itself a collection of ecosystems: 3-D computational virologists; a WHO-accredited bio level safety P4 facility hosting Ebola virus samples obtained from and cleared by the government of Sierra Leone during the West African outbreak; a GLP/GMP reagent facility and more.

This is an important reason why, during this pandemic, we already were positioned to produce three rapid diagnostic tests for COVD19. Our kits are produced by Astel Diagnostics LTD in Uganda. We have a long-standing partnership with Prof. Vinand Nantulya and Dr James Njuguna at Astel, which is a leading GMP-certified, WHO-accredited, NDA-cleared manufacturer of RDTs for HIV-1, syphilis, hepatitis, and malaria.

In 2019, you won the WHO Africa Innovation Challenge (R&D) with the Panfilovirus Rapid Diagnostic Test. What advice would you like to give to young African researchers who want to pursue a career in science?

Truthfully, I was honoured by this 1^st prize. Most work behind the scenes never gets the limelight. That award has helped us to show-case many years of work and inspired confidence in what we do. I may be still relatively young but in terms of work, I am quite senior in the making. The Panfilovirus RDT® work alone took more than 13 years. The HIV cure work (funded by the GlaskoSmithKline Trust in Science-Africa), has more than 20 years behind it. So, I would argue, the trick is to find your passion early, and spend much of your life pursuing it. This will also keep you out of a lot of danger, which all young people face daily.

Whereas there is inexhaustible advice I could give to young African researchers, perhaps nothing beats that offered by Richard Hamming in his 1986 talk titled “You and your research”, at the Bell Labs Colloquium. The journal PLoS computational biology has condensed J.F Kaiser’s transcript of this talk, into Ten simple rules for doing your best research, according to Hamming. The only thing I can perhaps emphasise is that African researchers must get their courage up to solve Africa’s persistent development challenges, including those related to health.

Dr Misaki Wayengera

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Diagnostics are the most important tools for curbing an epidemic or pandemic since they enable case detection for isolation and/or treatment. You cannot confront an enemy you cannot identify. The world must invest in low-cost, rapid diagnostic technology platforms, suitable for use at the point of care.

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In 2018, Dr Wayengera started his EDCTP career development fellowship. Then, in October 2018, he received a grant under the Ebola emergency call (September 2018) for his research project on a rapid diagnostic test for the detection of both the EBOV and Marburg viruses (AdjustEBOVGP-Dx project). The development by him and his team of the rapid diagnostic test for viral haemorrhagic fevers (Ebola and Marburg viruses) won him in 2019 the first prize in the category R&D of the WHO AFRO Innovation Challenge.

What lessons regarding diagnostics can we learn from recent epidemic outbreaks like Ebola and how can they contribute to the response against COVID-19?

MW: Diagnostics are the most important tools for curbing an epidemic or pandemic since they enable case detection for isolation and/or treatment. You cannot confront an enemy you cannot identify. The world must invest in low-cost, rapid diagnostic technology platforms, suitable for use at the point of care. 

Therefore, I urge developing countries to scale up their contribution to R&D and do it generously. R&D is riddled with unpredictable bottlenecks that can only be overcome with sustained funding, such as Grand Challenges Canada and EDCTP have done for the Panfilovirus RDT®. Without that, we could not have developed the prototypes, which are now due for clinical validation in the ongoing Ebola virus disease outbreak in Beni, DRC.