Abbott has received a CE Mark for its Panbio Covid-19 antigen self-test, which allows the company to directly sell the product to consumers throughout Europe. The is designed to detect the SARS-CoV-2 virus in adults and children suffering with or without symptoms. The over-the-counter approval is expected to speed access to safe and reliable Covid-19 self-testing.
Avellino Lab USA, a molecular diagnostics company, announced that more than two million of its AvellinoCoV2 tests have now been performed in the US. It was one of the first tests to receive an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) March 2020. The test offered much-needed capacity during the early days of the pandemic in the country, particularly in nursing facilities, government municipalities, schools, and colleges. The AvellinoCoV2 test targets the N-gene region of the SARS-CoV-2 virus, which is less prone to mutations seen in Covid-19 variants, thereby helping to prevent false negatives.
Meridian Bioscience, a global diagnostic testing solutions provider, announced that it has re-submitted an Emergency Use Authorisation (EUA) application to the US FDA for its SARS-CoV-2 molecular diagnostic test on the Revogene platform. On 22 February 2021, Meridian had voluntarily withdrawn its EUA application to conduct additional research based on FDA guidance. Meridian completed its additional studies and re-applied for EUA on 25 June 2021.