Mologic receives CE mark approval for professional-use COVID-19 rapid antigen test

Mologic, one of the leading developers of lateral flow and rapid diagnostic technologies, has announced its professional-use COVID-19 Rapid Antigen Test has been certified with a CE mark, following independent assessment by the Liverpool School of Tropical Medicine (LSTM). The test will provide health professionals an accurate detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs, within 10 minutes. Development and validation were supported by the Wellcome Trust and the Foreign, Commonwealth and Development Office (FCDO) Joint Initiative on Research in Epidemic Preparedness and Response.

Independent assessment at Liverpool University Hospitals NHS Foundation Trust, as part of the FASTER study with 28 patients presenting for care, resulted in a sensitivity of 92%, and a specificity of 100%, corresponding to RT-qPCR-confirmed COVID-19 cases. Limit of detection studies estimate a 50% Tissue Culture Infectious Dose (TCID50/ml) of 100-350 (<5x10^2 pfu/ml), a key tool for estimating the infectious titre of a virus.

Considering the preliminary number of patients included so far, further studies are planned across the UK with St George’s University of London, Northumbria Healthcare NHS Foundation Trust, Imperial College London, Nottingham University Health Trust, and the Hull Royal Infirmary, with expected report findings in January 2021. The data is available on request, pending full publication of results.

In addition, Mologic’s COVID-19 Rapid Antigen Test has been invited to take part in the US National Institutes of Health (NIH) RADx initiative that will fast-track development, manufacture, and regulatory submissions.

Global validation trials have begun with the Institut Pasteur de Dakar in Senegal, West Africa and will commence in Boston, USA, and in Jakarta, Indonesia, from January 2021. Dossiers will be prepared for submission to the US FDA and WHO at that same time.

To guarantee access to the rapid test in low- and middle-income countries, the COVID-19 Rapid Antigen Test will be manufactured and made available by Global Access Diagnostics (GAD), at cost of production and distributed through commercialisation partners.

Dr Joe Fitchett, Medical Director and Epidemics lead, Mologic, commented: “The findings are preliminary but very encouraging. We are therefore extending trials in the UK, the US, Senegal, and Indonesia thanks to support from the Wellcome Trust. We look forward to transferring the COVID-19 Rapid Antigen Test for joint manufacture in Europe and in Africa with the Institut Pasteur de Dakar in Senegal”.

Dr Emily Adams, Liverpool School of Tropical Medicine, commented: “LSTM are pleased to be continuing their collaboration with Mologic, and preliminary results suggest that their antigen test is highly sensitive and specific, although in small numbers of recruits so far. We look forward to full evaluation data in the new year.”

Dr Amadou Sall, Director for the Institut Pasteur de Dakar in Senegal, commented: “In the context of second wave for COVID-19 in Africa, a low-cost rapid antigen test can be a game changer to bend the curve, and we look forward to manufacturing it at Institut Pasteur de Dakar.”

Prof. Luis Cuevas, Liverpool School of Tropical Medicine, commented: “Mologic’s low-cost rapid antigen detection tests will signal a step change for health services in low- and middle-income countries, where the supply of tests is limited. The tests will, for example, facilitate the field confirmation of epidemic hot spots, the rapid identification of symptomatic patients that can be admitted to COVID wards and more comprehensive surveillance.”

Prof. Sanjeev Krishna, St George's University of London, commented: ‘The urgency for affordable diagnostics that are quality assured has been highlighted by the need to free people from quarantine and enable travel. Working within a consortium with Mologic and academic partners has been one of the most effective ways to develop such tests.”

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