Mologic Receives CE Mark Approval COVID-19 Rapid Antigen Test
BEDFORDSHIRE, UK - December 24, 2020 - Mologic Ltd, a leading developer of lateral flow and rapid diagnostic technology, is pleased to announce that its COVID-19 rapid antigen test for professional use has been certified with a CE mark, following an independent assessment by the Liverpool School of Tropical Medicine (LSTM). The test will provide healthcare professionals with accurate detection of SARS-CoV-2 virus nucleoprotein in respiratory swabs, within 10 minutes. Development and validation was supported by the Wellcome Trust and the Foreign, Commonwealth and Development Office (FCDO) Joint Initiative on Research in Epidemic Preparedness and Response.
"The urgency of affordable, quality-assured diagnostics has been underscored by the need to release people from quarantine and allow travel," commented Professor Sanjeev Krishna, from St George's University in London. "Working in 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, yielded a sensitivity of 92% and specificity of 100%, matching confirmed COVID-19 cases by RT-qPCR. 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 titer of a virus.
Given the preliminary number of patients included so far, further studies are planned across the UK with St George's University London, Northumbria Healthcare NHS Foundation Trust, Imperial College London, Nottingham University Health Trust and the Hull Royal Infirmary. January 2021. Data are available on request, pending full release of results.
Additionally, Mologic's COVID-19 Rapid Antigen Test has been invited to participate in the U.S. National Institutes of Health (NIH) RADx initiative which will expedite development, manufacturing and regulatory submissions.
Global validation trials have started with Institut Pasteur de Dakar in Senegal, West Africa and will start in Boston, USA and Jakarta, Indonesia from January 2021. Dossiers will be prepared to be submitted to the US FDA and WHO at the same time. .
To ensure 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 of marketing partners.
Dr. Joe Fitchett, Medical Director and Head of Epidemics at Mologic, commented: “The results are preliminary but very encouraging. We are therefore expanding trials in the UK, US, Senegal and Indonesia with support from the Wellcome Trust. We look forward to transferring the COVID-19 rapid antigen test for joint manufacturing in Europe and Africa with Institut Pasteur de Dakar in Senegal.