Mologic, the US subsidiary of Global Access Diagnostics (GADx), has announced that its proprietary COVI-Go SARS-CoV-2 Ag Self-Test received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for over-the-counter home use.
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 neutralises 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 two 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.
The development of the test was funded through the US National Institutes of Health (NIH) RADx initiative. As a social enterprise, COVI-Go will be commercialised through partnering with other organisation(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 prioritising US manufacturing, deployment and equitable access to testing across the country.”
Global Access Diagnostics (GADx) is a social enterprise prioritising equitable access to diagnostics and driving local manufacturing to create sustainable independent production. GADx was formed by the acquisition of two companies, Mologic and Global Access Diagnostics, by a consortium of social impact investors called Global Access Health. As part of this transition, GADx became a social enterprise, dedicating its profits and mission to improving the health and wellbeing of underserved populations around the world. GADx is headquartered in Bedford in the United Kingdom and has a US subsidiary, Mologic Inc, situated in Maine, New Gloucester.
For more information visit www.globalaccessdx.com.
