A rapid COVID-19 antigen test, validated by researchers at Liverpool School of Tropical Medicine (LSTM) through the Infection Innovation Consortium (iiCON), will be used to deliver large-scale testing in key areas of need in Africa as part of a major FIND and UNITAID programme.
The tests, developed by Mologic Ltd, a leading developer of lateral flow and rapid diagnostic technologies, provide health professionals with an accurate detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs, within 10 minutes.
As part of a collaboration supported by iiCON’s specialist diagnostics platform, independent validation and testing by LSTM enabled Mologic’s test to secure CE mark certification.
The consortium supported development and validation through a joint grant from the Wellcome Trust and the Foreign, Commonwealth and Development Office (FCDO) Joint Initiative on Research in Epidemic Preparedness and Response.
Now, Mologic’s tests will play a key role in supporting high-quality rapid testing across Africa as part of a major programme of investment being delivered through FIND and Unitaid to support technology transfer and boost local production of COVID-19 rapid tests in low- and middle-income countries.
A technology transfer agreement has been signed between Mologic and DIATROPIX of the Institut Pasteur de Dakar in Senegal to enable expanded production of high-quality antigen rapid tests across the continent. DIATROPIX is being supported by FIND and Unitaid to scale up manufacturing of Ag RDTs transferred from Mologic Ltd.
DIATROPIX will seek regulatory authorization for the transferred tests and commercialise them under its own brand, with the aim of reaching 2.5 million tests per month by 2022, at prices ranging from US$2.50 to US$2.00 (ex-works) with a view to further reductions in the near future.
Recently released WHO guidance on national SARS-CoV-2 testing strategies emphasises the important role of high-quality Ag RDTs. They remain the primary diagnostic test for detection of active SARS-CoV-2 infection in decentralised settings where timely molecular testing is not available.
The pandemic has exposed how fragile health systems and an exclusive reliance on global supply chains leave many countries without access to the tests they need to control COVID-19.
Today, high-income countries are testing people for COVID-19 over 60 times more than low-income countries. Expanded production capacity in local and regional hubs is critical to ensuring that healthcare providers in low- and middle-income countries (LMICs) can implement effective testing strategies to contain the spread of the virus.
Dr Joe Fitchett, Medical Director at Mologic, said: “We’re delighted to have confirmed a technology transfer agreement with DIATROPIX as part of this significant FIND and UNITAID programme. Through this agreement, our product will deliver significant benefit across the African continent – supporting some of our most vulnerable global communities with the diagnostics they need to contain the virus.
“The Centre for Drugs and Diagnostics at LSTM, working through the iiCON platform, supported and enabled the evaluation of our antigen test and secure the validation and accreditation needed to bring it to market. We are incredibly pleased that this collaborative effort has resulted in an innovative, affordable product that will now be rolled out widely and play a role in easing the global burden of infectious disease.”
Dr Emily Adams, who has recently been appointed Director of Epidemics and NTDs at Mologic, led LSTM’s diagnostic team in their evaluation of the test last year. She said: “We were delighted to evaluate this test, which will now be made available at cost price across Africa. These tests are the most appropriate kind of test and potentially a game-changer for the region, which is central to LSTM’s mission to bring relief to those living in diseases endemic countries, especially in low resource settings.
“The fact that the test will be manufactured in Africa through DIATROPIX means that the test will be local and readily available to provide those on the front line with effective diagnostic tools that will help ease the burden of COVID-19 in Africa.”
LSTM’s Professor Janet Hemingway, founding Director of iiCON, said: “Working with industry to support the development of innovative diagnostics and anti-infectives and overcome barriers to market is at the heart of iiCON’s purpose. The consortium, supported by the UKRI Strength in Places initiative, is designed to bolster the anti-infective pipeline and provide the global community with innovative therapeutics and diagnostics to tackle COVID and other key infectious diseases. This project is a great example of the regional, national and international impact of the iiCON programme.
“LSTM’s diagnostics team, based within iiCON, worked closely with Mologic and St George’s Hospital, University of London to support the company through testing and validation to bring their outstanding diagnostic product to market quickly, cost effectively, and safely. We are delighted that Mologic’s product will be used across Africa under this key agreement which will support the global COVID effort and bring real benefit to communities across the continent.”
iiCON, which is led by LSTM, bridges the gap in the infection innovation ecosystem between industry, academia, and the NHS to accelerate and support the discovery and development of innovative new anti-infectives.
The consortium proactively identifies and engages with the most innovative companies working in the sector globally. iiCON forges long-term collaborative relationships with these organisations and facilitates impactful partnerships that accelerate and enable innovative research and product development – bringing the next generation of game-changing new products to market more quickly, safely, and affordably.
The iiCON consortium comprises LSTM, Liverpool University Hospitals NHS Foundation Trust, Unilever UK, the University of Liverpool, Infex Therapeutics, and Evotec at Alderley