Mologic and Partners Begin Validation Process for COVID-19 Point-of-need Diagnostic Test

Mologic Ltd has announced that it has initiated early validation of COVID-19 point-of-need diagnostic tests with the Liverpool School of Tropical Medicine and St Georges’ University London.

The availability of fast, reliable diagnostics for COVID-19 has been identified as one of the critical opportunities to support the control of the pandemic and “flatten the curve” of cases worldwide.

The accelerated development of the test has been made possible by funding from UK Aid, as part of the £46 million the UK government has announced so far for international coronavirus (COVID-19) prevention and research.

Mologic’s early prototypes of antibody tests have made it possible to begin a process of optimization. Leading laboratories on each continent will evaluate these different prototypes to independently assess their performance.

While the assessment and optimization will be expedited, it is vital that any prototype device for COVID-19 is subject to rigorous validation before it is made available for use in the global pandemic response.

Following rapid assessments in the UK, the technology will be shipped to global validation partners including the Institut Pasteur de Dakar in Senegal, La Jolla Institute for Immunology in the United States, the Wuhan Institute of Virology in China, the University of Malaya in Malaysia, the Institute for Health Science Research Germans Trias I Pujol (IGTP) in Spain, and the Oswaldo Cruz Foundation (Fiocruz) in Brazil.

Once ready, the device will allow users to test for exposure to the virus at home, in the community, or in the clinic, providing a result within 10 minutes, without the need for special training, electricity or a laboratory. The company is working in close partnership with the Institut Pasteur de Dakar to validate the COVID-19 test and manufacture at diaTROPiX, a new facility in Senegal. This will be the first time that a diagnostic kit created in the UK will be jointly manufactured in Africa, ensuring tests are available in settings with limited access to laboratory facilities.

Mologic has taken the decision to sell the diagnostic test at cost to low-income settings to ensure affected countries have access to the kits during the global emergency. This will allow high-quality diagnostics to be produced in low-income settings with the aim of ensuring that the test is available to all.

Professor Paul Davis, Co-Founder and Chief Scientific Officer, Mologic, 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.”

Dr Joe Fitchett, Medical Director, Mologic, said: “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.”

International Development Secretary Anne-Marie Trevelyan, said: “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.”

Dr Emily Adams, Senior Lecturer in Diagnostics for Infectious Disease, 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.”