RE: Mologic tweet6 Apr 2021 19:49
Here is the tweet, this test is for low-income countries which our RNS said we were working with Mologic to produce.
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
Bedfordshire, UK, 06 April 2021: Mologic, a leading developer of lateral flow and rapid diagnostic technologies, today 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 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.
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