Mologic, Thurleigh, UK, has launched an accelerated program with the Pasteur Institute of Dakar to develop a low-cost, high-performance rapid diagnostic test for Ebola virus disease.

The project is supported by the Wellcome Trust and the UK government’s department for international development through their joint call to advance epidemic preparedness. The World Health Organization declared Ebola a public health emergency of international concern in July 2019 for the North Kivu province of the Democratic Republic of Congo (DRC).

Amadou Sall, PhD, Pasteur Institute of Dakar.

Amadou Sall, PhD, Pasteur Institute of Dakar.

Mologic will apply ultrasensitive lateral-flow technology developed at the company’s center for advanced rapid diagnostics to lead product development and manufacture, while the Pasteur Institute of Dakar will lead validation of the test in collaboration with the Senegalese national institute for biology research. The test will be manufactured both in the United Kingdom and in Senegal at the Pasteur institute’s new diaTropix facility.

The early detection of a confirmed Ebola case is a major challenge and bottleneck in initiating an effective public health response to prevent the disease’s spread to urban centers. In addition, Ebola has overlapping symptoms with other endemic diseases, making an accurate diagnosis even more challenging.

Joe Fitchett, DrPH, Mologic.

Joe Fitchett, DrPH, Mologic.

By developing a simple test that can be deployed at the point of need, the project aims to overcome obstacles related to case identification, logistics, and sample transportation to a central qualified lab. Such a test has the potential to significantly improve response times and control of the epidemic through time-critical contact tracing, community engagement, immunization, and safe and dignified burial.

“Following the mobile ‘lab in a suitcase’ development that fostered rapid and decentralized Ebola testing in Guinea, this project will provide a breakthrough in the ecosystem of rapid diagnostic discovery, development, and delivery, not only for Ebola but for epidemic diseases in general,” says Amadou Sall, PhD, head of the arboviruses and viral hemorrhagic fever unit at the Pasteur Institute of Dakar. “In an era of regular emergencies caused by pathogens, our partnership will strengthen the capability of local communities who are first detectors and responders to any outbreak.”

A health worker at the Pasteur Institute of Dakar in Senegal.

A health worker at the Pasteur Institute of Dakar in Senegal.

The new Ebola diagnostic test builds on early development by Bioaster, the French technology research institute, during the West African outbreak from 2014 to 2016. It will detect the infection early in blood by embedding monoclonal antibodies against surface glycoproteins, one of the first detectable biomarkers of infection.

The glycoprotein-targeted detection prototype kit showed better diagnostic performances than commercially available VP40-based rapid diagnostic tests using viral culture supernatants and infected monkey plasmas.1 Six mouse-derived monoclonal antibodies to the glycoprotein of the Ebola virus have been developed by Bioaster, with their clinical evaluation demonstrating high performance with human infected samples. Staff of Mologic and the Pasteur Institute of Dakar are currently validating three prototypes.

With support from the Bill and Melinda Gates Foundation since 2016, Mologic has deepened its focus on epidemics and neglected diseases,” says Joe Fitchett, DrPH, medical director at Mologic. “For rapid epidemic preparedness and response, we need to have a platform that is readily modified according to a novel pathogen. This is increasingly important, especially when faced with emerging epidemics such as covid-19.”

For more information, visit Mologic.

Reference

1. Couturier C, Wada A, Louis K, et al. Characterization and analytical validation of a new antigenic rapid diagnostic test for Ebola virus disease detection. PLoS Negl Trop Dis. Epub January 17, 2020; doi: 10.1371/journal.pntd.0007965.