Mologic’s COVID-19 rapid antigen self-test receives FDA Emergenc y Use Authorization for home use
US subsidiary of Global Access Diagnostics (GADx) ‒ adeveloper of lateral flow and rapid diagnostic technologies, products and services ‒ Mologic , has announced that its COVID-19 rapid antigen self-test has received FDA Emergency Use Authorization (EUA).
COVI-Go COVID-19 Self-Test is a differentiated, rapid antigen test composed of an anterior nasal swab and test device ‒ eliminating the need for the mixing and pouring of buffer solutions. The test qualitatively detects nucleocapsid protein antigen from SARS-CoV-2 in around 20 minutes.
Mark Davis, CEO of GADx, stated: “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. GADx has been invaluable in supporting the product prototype through clinical trial and EUA registration. Accordingly, we are prioritising US manufacturing, deployment and equitable access to testing across the country. As a social enterprise, we will be leveraging manufacturing scale, knowledge and FDA authorisation in launching COVI-Go. Being focused 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 unitised 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.”