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Mologic, a leading developer of lateral flow and rapid diagnostic technologies, has announced its rapid antigen self-test for COVID-19 has been selected by the Rapid Acceleration of Diagnostics (RADxSM) initiative launched by the U.S. National Institutes of Health (NIH). The initiative aims to speed innovation in the development, commercialisation, and implementation of technologies for COVID-19 testing. 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 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 RADxSMinitiative, 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.
Mologic is a leading developer of advanced lateral flow and rapid diagnostic technologies. Leveraging its core technology platforms, the Company works with global organisations, researchers and clinicians to help them deliver fast, reliable and accurate diagnosis at the point-of-need. Mologic’s founder, Professor Paul Davis, was one of the co-inventors of the Clearblue pregnancy test that was launched in 1988 as the world’s first commercial application of lateral flow technology. The creativity, insight and knowledge that led to that ground-breaking invention has guided Mologic since its formation in 2003.
Mologic offers world-leading technology and scientific research expertise for contract research and development, alongside a portfolio of device and reagent products for clinical applications. The Company also helps organisations to scale-up manufacturing from initial prototyping through low to mid-scale production. Mologic’s science has broad application across markets and disease states where rapid, accurate point-of-need testing can help make a difference in patient care and patient outcomes.
Clients include the Bill & Melinda Gates Foundation where Mologic is leveraging core technology through its Centre for Advanced Rapid Diagnostics (CARD) to develop the next-generation of ultra-sensitive point-of-need diagnostics which are easy to use and low cost to manufacture - critical to the success of many global health programmes.
The Company is actively seeking strategic partners for its internal pipeline of respiratory, infectious disease and women’s health diagnostics.
Mologic is headquartered in Bedford in the United Kingdom and has a US subsidiary in the greater Boston area, MA, USA.