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· Novel two-component, all-in-one design significantly simplifies testing for consumers
· COVI-Go delivers results in 20 minutes; suitable for age 2 and above
· FDA Emergency Use Authorization permits over-the-counter self-use for people with or without symptoms
New Gloucester, Maine, USA, February 23rd, 2023 – Mologic Inc., the US subsidiary of Global Access Diagnostics (GADx), a leading developer of lateral flow and rapid diagnostic technologies, products and services, announced today that its proprietary COVI-Go™ SARS-CoV-2 Ag Self-Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter home use. The development of the test was funded through the US National Institutes of Health (NIH) RADx ® initiative*.
The COVI-Go COVID-19 Self-Test is a differentiated, rapid antigen test that is easy to use with its proprietary, streamlined design comprising of two components only - an anterior nasal swab and test device. This all-in-one testing format eliminates the need for mixing and pouring of buffer solutions. The self-contained unit is safe and portable with an integrated buffer that fully neutralizes the COVID-19 virus present in the sample to reduce biohazard risk and cross-contamination. The design makes testing possible anywhere and by individuals aged 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old. Following a few simple steps, the test qualitatively detects the nucleocapsid protein antigen from SARS-CoV-2 in approximately 20 minutes. Of those who tested, 97% of patients agreed that the COVI-Go Self-Test was easy to perform.
As a social enterprise, COVI-Go will be commercialized through partnering with other organization(s) to support manufacturing to meet demand and will address the needs of low and middle income groups in the US and worldwide
Mark Davis, CEO of GADx, said: “Validation of the COVI-Go Self-Test by the FDA under EUA is a significant step in supporting the global fight against the threat of COVID-19. RADx has been invaluable in supporting the product prototype through clinical trial and EUA registration. Accordingly, we are prioritizing US manufacturing, deployment and equitable access to testing across the country.”
He added: “As a social enterprise, we will be leveraging manufacturing scale, knowledge and FDA authorization in launching COVI-Go. Being focussed on accessibility for all, the device is unique in having been developed specifically for the home user whatever their situation. COVI-Go was made for everyday people and we look forward to supporting our partners in marketing its positive accessibility aspects, which also received positive feedback from accessibility groups like the Americans with Disabilities Act (ADA), highlighting its unique unitized design and easy to use functionality. As COVID-19 is here to stay alongside associated health challenges, the ability to leverage such a platform with the inclusion of additional respiratory diseases will be paramount to our continued strategy.”
*This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx®) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92021C00010.
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