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Mologic Receives CE Mark for COVID-19 Rapid Antigen Test

NEW YORK – Diagnostic firm Mologic said on Thursday it received the CE mark for its COVID-19 Rapid Antigen Test.

In preliminary findings in 28 symptomatic patients with PCR-confirmed COVID-19, the test diagnosed infection with a sensitivity of 92 percent and specificity of 100 percent.

The Bedfordshire, UK-based company is now planning additional UK studies at St. George’s University of London, Northumbria Healthcare NHS Foundation Trust, Imperial College London, Nottingham University Health Trust, and the Hull Royal Infirmary, and plans to report findings in January 2021.

Mologic has also started global trials with the Institut Pasteur de Dakar in Senegal, West Africa and plans to launch additional trials in Boston and Jakarta, Indonesia in January. It has also been invited to take part in the US National Institutes of Health's RADx initiative.

The company said that to guarantee access to the test in low- and middle-income countries, it will be manufactured and made available by Global Access Diagnostics at the cost of production.

"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," Luis Cuevas, professor of tropical epidemiology at Liverpool School of Tropical Medicine, said in a statement. "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."