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Mologic secures CE mark for rapid antigen test

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Mologic say their findings are very encouraging

Mologic, a developer of diagnostic technologies, has announced that its professional-use COVID-19 Rapid Antigen Test has been certified with a CE mark.

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.

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.

Additionally, 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.

Dr Joe Fitchett, medical director and epidemics lead, Mologic, said:“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.

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.

Professor Luis Cuevas, Liverpool School of Tropical Medicinesaid: “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.

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