The US Food and Drug Administration (FDA) has re-authorised the emergency use authorization (EUA) for Meridian Bioscience’s Revogene SARS-CoV-2 molecular assay.
The regulator initially granted EUA for the Covid-19 molecular diagnostic test last November.
However, the company decided to delay the marketing of the assay so that its design could be modified to correctly detect the Omicron variant.
Meridian Bioscience completed this development work and submitted an initial set of data to the FDA for validation of the redesigned assay’s performance in March.
