Mologic Inc., a leading provider of lateral flow and quick diagnostic technologies, products, and services, disclosed that the US Food and Drug Administration (FDA) had granted emergency use approval (EUA) for its proprietary COVI-Go SARS-CoV-2 Ag Self-Test for over-the-counter use at home. With the US National Institutes of Health (NIH) RADx initiative, the test’s development was financed.
The COVI-Go Covid-19 Self-Test is a unique, quick antigen test that is simple to use thanks to its simplified, innovative design, which consists of only two parts: an anterior nasal swab and test gadget. Buffer solutions don’t need to be mixed or poured when using this all-in-one testing method. The mobile, self-contained equipment is safe and completely neutralises the Covid-19 virus found in the sample, lowering the danger of cross-contamination and biohazards. A nasal swab obtained by an adult from a child as young as 2 years old can be tested anywhere and by anyone who is at least 14 years old. The test takes only a few quick steps and takes around 20 minutes to qualitatively identify the nucleocapsid protein antigen from SARS-CoV-2.
COVI-Go, a social enterprise, will answer the requirements of low- and middle-income groups in the US and around the world by partnering with other organisations to promote production to meet demand.
“Validation of the COVI-Go Self-Test by the FDA under EUA is a crucial step in assisting the international campaign against the threat of Covid-19,” stated Mark Davis, CEO of GADx. Through clinical trials and EUA registration, RADx has been a crucial support system for the product prototype. We are giving American production, deployment, and fair access to testing a priority as a result.
In developing COVI-Go, he continued, “As a social enterprise, we will be using manufacturing size, expertise, and FDA authorization. The device is special in that it was created exclusively for the home user, regardless of their situation, and is focused on accessibility for everyone. The Americans with Disabilities Act (ADA) and other accessibility organisations have praised COVI-Go for its distinctive unitized design and user-friendly functionality. COVI-Go was created for regular people, and we look forward to assisting our partners in marketing its positive accessibility aspects. The potential to use such a platform with the inclusion of more respiratory disorders will be crucial to our future approach because Covid-19 is here to stay along with accompanying health issues.
