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Mologic Receives CE Mark Approval for Professional-Use COVID-19 Rapid Antigen Test

by Mologic
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BEDFORDSHIRE, UK — December 24, 2020 — Mologic Ltd, a leading developer of lateral flow and rapid diagnostic technologies, is pleased to announce 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.

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

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 percent, and a specificity of 100 percent, corresponding to RT-qPCR-confirmed COVID-19 cases. Limit of detection studies estimate a 50 percent tissue culture infectious dose (TCID50/ml) of 100-350 (<5x10^2 pfu/ml), a key tool for estimating the infectious titer 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 commercialization 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.”

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