NEW YORK – Mologic said Tuesday that it has launched an accelerated program with the Institut Pasteur de Dakar to develop a low-cost, high-performance rapid diagnostic test for Ebola virus disease.
Bedfordshire, UK-based Mologic said that it will apply ultra-sensitive lateral flow technology developed at its Centre for Advanced Rapid Diagnostics and lead product development and manufacturing. Senegal-based Institut Pasteur de Dakar will lead test validation in collaboration with the Institut National de Recherche en Biologie (INRB) in Kinshasa, Democratic Republic of the Congo (DRC). The collaborators anticipate manufacturing the test in the UK and in Senegal at the Institut Pasteur de Dakar.
Mologic and Institut Pasteur de Dakar staff are currently validating three rapid diagnostic test prototypes prior to initiating a trial with INRB in the DRC during March 2020.
Financial and other terms of the deal were not disclosed.
The new test is being developed to detect the Ebola infection early in blood by embedding monoclonal antibodies against surface glycoproteins. The project is building on development work by BIOASTER, the French Technology Research Institute, during the West Africa outbreak from 2014 to 2016, Mologic said.
BIOASTER has developed six mouse-derived monoclonal antibodies to the surface glycoproteins of the Ebola virus that have been shown to have high performance in a clinical evaluation involving human infected samples. A surface glycoprotein-targeted detection prototype showed better diagnostic performance than commercially available rapid diagnostic tests using viral culture supernatants and infected monkey plasmas, said Mologic, citing a clinical study.
Early detection of a confirmed Ebola case is a major challenge that can be a bottleneck to initiating an effective public-health response and preventing its transmission to urban centers in DRC and internationally, Mologic said. The disease has overlapping symptoms with other endemic diseases, making an accurate diagnosis even more challenging.
"With support from the Gates Foundation, since 2016, Mologic has deepened its focus on epidemics and neglected diseases," the firm's Medical Director Joe Fitchett said in a statement.
The new project aims to overcome obstacles associated with case identification, logistics, and sample transportation to a central qualified lab, by developing a simple test deployed at the point of need, Mologic said.
The test has potential to significantly improve response times and control of the epidemic through time-critical contact tracing, community engagement, immunization, and safe and dignified burial, the firm added.