New Lab-based COVID-19 Antibody Tests Launched

Mologic Ltd, a leading developer of lateral flow and rapid diagnostic technologies, has announced that it will begin manufacturing its laboratory diagnostic test for COVID-19. Following successful independent validation by the Liverpool School of Tropical Medicine and St George’s, University of London, the test has also been submitted to Public Health England for formal validation.

Mologic has entered into a Material Transfer Agreement with Omega Diagnostics Ltd and Omega will immediately start manufacture of Mologic’s first-generation ELISA diagnostic tests. The laboratory-based ELISA diagnostic test is expected to produce up to 46,000 results per day, potentially contributing a significant portion of the UK government’s planned 100,000 tests per day.

Mologic will make the technology and materials for its tests available for use in Africa through a partnership with the Institut Pasteur de Dakar in Senegal, in order to support efforts to contain the pandemic on the continent. The availability of fast, reliable diagnostics for COVID-19 has been identified as a critical opportunity to facilitate contact tracing and ‘flatten the curve’ of the global pandemic.

Since March, leading laboratories across the world have partnered with Mologic to evaluate a variety of diagnostic prototypes and independently assess performance. Results have now been submitted to Public Health England for review. While the assessment and optimisation has been 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.

Mark Davis, CEO, Mologic: “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.”

Dr Joe Fitchett, Medical Director, Mologic: “Alongside the Liverpool School of Tropical Medicine and St George’s, University of London we launched a radically open, responsive, and rapid validation model to accelerate the submission of our COVID-19 diagnostics to Public Health England and for regulatory approval. Our laboratory and point-of-need tests will allow individuals to detect whether they have antibodies to COVID-19 and bring us one step closer to improving access to high quality diagnostics.”

Colin King, CEO, Omega Diagnostics Group PLC: “I am pleased that Omega has been able to support Mologic with the development and scale up of their ELISA test. This is another example of the UK diagnostics industry working in collaboration to bring effective solutions in the fight against this global pandemic.”

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