Mologic, a UK-based developer of lateral flow and rapid diagnostic technologies, announced on April 9 that its rapid antigen self-test for COVID-19 has been selected by the Rapid Acceleration of Diagnostics (RADx) initiative launched by the National Institutes of Health (NIH). Mologic’s easy-to-use nasal-swab test is intended for use by non-health professionals at home and accurately indicates the presence of SARS-CoV-2 nucleoprotein in approximately 20 minutes.
Mologic’s independently verified COVID-19 lateral flow technology combines all reagents in a unique design, and integrates reporting of results. The self-test can be used by a person without medical training at the point-of-need, including home, workplace, education and travel settings. Limit of detection and analytical sensitivity have been independently assessed by researchers at St Georges’ University of London, led by Dr Elisabetta Groppelli.
Accurate, fast, easy-to-use, and widely accessible testing is required before the world can safely return to normal life. To meet this challenge, with the support of the NIH RADx initiative, Mologic will accelerate development and clinical validation of its COVID-19 self-test, with guidance provided on US regulatory approvals (Emergency Use Authorization, or EUA) from the U.S. Food and Drug Administration (FDA). The initiative aims to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing.
Following successful completion of Phase 1 (development phase) of the initiative, Mologic’s self-test is continuing into Phase 2 (scale-up and manufacturing) intended for projects at an advanced stage of readiness.
Mologic aims to ensure affordable access to its COVID-19 diagnostics across all health systems, with low-income countries being given access to tests at cost through commercial and distribution partnerships. This will help to improve early detection and contact tracing in places with weaker health systems and vulnerable populations. Mologic has a long-standing partnership with the Institut Pasteur de Dakar on its flagship manufacturing facility, diaTROPiX, focused to provide quality diagnostics at cost for the African continent.
Mologic is also making this unique self-test design available to its customers and partners across a broad range of self-test applications, through the company’s contract research & manufacturing programme.
"We often hear that viruses are invisible, but we simply need the right technology to see them. So far, testing technologies have existed in diagnostic and research laboratories, but it is now crucial that testing becomes more accessible," said Groppelli, Virologist and Lecturer in Global Health and Medical Research Foundation Fellow at St George’s. "Our work in the research laboratory at St Georges’ University of London shows that the new home tests developed by Mologic offer the high-quality specifications that are needed to see the virus, but without the requirement for a laboratory or specialist expertise. This is fantastic news because, if we can see the viral enemy, we will be able to tackle it much more effectively.”
This project is being funded in whole or in part with federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92021C00010.