COVID-19 diagnostic test to be manufactured following successful validation

Written by Kate Lovesey, Future Science Group

Update: 20 April 2020

Mologic Ltd (Bedford, UK), a developer of lateral flow and rapid diagnostic technologies has announced that its laboratory diagnostic test for COVID-19 has successfully been independently validated by Liverpool School of Tropical Medicine (UK) and St George’s University of London (UK). The test will enter the manufacturing process immediately.

The first-generation ELISA diagnostic tests are to be submitted to Public Health England for a formal validation. Manufacturing will begin immediately by Omega Diagnostics Ltd (Cambridgeshire, UK) following a Material Transfer Agreement with Mologic Ltd.

It is hoped the laboratory-based test will be able to contribute up to 46,000 results a day, a significant portion of the UK government’s daily test target of 100,000. The test will be prioritized for health services and key worker communities in the UK and Africa as a result of Mologic Ltd’s partnership with the Institut Pasteur de Dakar (Senegal).

Mark Davis, CEO (Mologic) commented: “The launch of Mologic’s laboratory-based test for COVID-19 is an exciting development in our efforts to support the global pandemic response. With the capability to process tens of thousands of tests results every day, these kits will relieve immediate testing pressures in the UK and Africa.”


25 March 2020

Researchers from Mologic Ltd (Bedford, UK), a developer of lateral flow and rapid diagnostic technologies are currently validating a COVID-19 diagnostic test with the Liverpool School of Tropical Medicine (UK) and St Georges’ University (London, UK). Prototype tests are to be sent to laboratories around the world for independent evaluation. The test, which is set to be manufactured at diaTROPIX (Senegal) – could facilitate the fast and reliable diagnosis of COVID-19.

COVID-19 hubEmily Adams, Senior Lecturer in Diagnostics for Infectious Diseases  (Liverpool School of Tropical Medicine), commented: “We are extremely pleased to be working alongside Mologic and diaTROPiX on the evaluation and validation of rapid diagnostic tests for COVID-19. These tests could be a game changer for diagnosis and follow-up of patients both in hospital and in the community, allowing us to detect cases early and isolate patients and their families rapidly. Of course in low-resource settings, where we are starting to see cases, these are the only tests that are appropriate for use. We need to manufacture and deliver as soon as we possibly can”

The accelerated development of this COVID-19 diagnostic test – which makes use of gold nanoparticles to detect COVID-19 biomarkers – has been made possible by UK aid, as part of the £46 million the UK government has made available for COVID-19 research. However, rigorous testing is still required before the diagnostic test is made available for human use.

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International Development Secretary (UK) Anne-Marie Trevelyan, explained: “The UK has been at the heart of the global response to the coronavirus outbreak, investing heavily in the research and development of potential new tests and vaccines, including the work of world-class scientists across the UK. It is enormously encouraging to see the progress the British-based lab Mologic, funded by UK aid, has already made to develop a reliable test for the virus, for use in the UK and around the world.”

Prototypes of this COVID-19 diagnostic test will be delivered to world-leading laboratories including, the Institut Pasteur de Dakar (Dakar, Senegal), La Jolla Institute for Immunology (CA, USA), the Wuhan Institute of Virology (China), the University of Malaya (Kuala Lumpur, Malaysia), the Institute for Health Science Research Germans Trias I Pujol (Catalonia, Spain) and the Oswaldo Cruz Foundation (Rio de Janeiro, Brazil). These laboratories will independently assess the ability of the test to quickly and reliably diagnose COVID-19.

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Paul Davis, Co-Founder and Chief Scientific Officer (Mologic Ltd) commented: “Completion of the first prototypes is a significant step in Mologic’s development of a rapid diagnostic test for COVID-19 and we are proud of our team’s achievement in reaching this point so quickly, while maintaining the most rigorous standards. Diagnostics are a critical weapon in the fight against this pandemic and, once ready, this test will enable affordable, more accurate and earlier diagnosis of infection, limiting the spread of the disease.”

Once the COVID-19 diagnostic test has been validated by the international laboratories, it is anticipated that it will allow users to test their exposure to the COVID-19 virus at home, in the community, or in the clinic. The test could provide results within 10 minutes, without the need for special training, electricity or a laboratory.

Joe Fitchett, Medical Director (Mologic Ltd, UK), explained: “Until a vaccine is ready or a medicine is proven to be effective, we need to decentralize diagnostics to the community as quickly as possible. Properly assessing new tests during an epidemic is a critical and necessary step to ensuring access to the technology. Mologic’s prototypes will now be subject to international validation, with leading labs across the world.”

Mologic Ltd are working with the Institut Pasteur de Dakar to validate and manufacture their COVID-19 diagnostic test at diaTROPiX, a new facility in Senegal. It is intended that this UK-created COVID-19 diagnostic test will be jointly manufactured in Africa and made available to low-income countries with limited access to laboratories.

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