Supported by US initiative to accelerate development and manufacturing including regulatory guidance
Advanced diagnostic technology and fully integrated proprietary design requires no specialist training and can be performed at home
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 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 RADxSM initiative, Mologic will accelerate development and clinical validation of its COVID-19 self-test, with guidance provided on US regulatory approvals (Emergency Use Authorization; EUA) from the U.S. Food and Drug Administration (FDA).
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.
Dr Elisabetta Groppelli, Virologist and Lecturer in Global Health and Medical Research Foundation Fellow, St George’s University of London commented: "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. 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 specialistic expertise or laboratory. This is fantastic news because, if we can see the viral enemy, we will be able to tackle it much more effectively.”
Mark Davis, CEO, Mologic added: “Mologic is totally focused on supporting efforts to tackle the COVID-19 pandemic and improve access to rapid testing technology that will help open up society and the economy. We are delighted to be part of RADx program in the US and look forward to seeing Mologic diagnostics rolled out there and across the world through our LMIC partners.”
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.