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.
Later, the company completed additional clinical studies to obtain EUA re-authorisation.
It intends to commence shipping of the assay before the end of its fiscal fourth quarter, which ends on 30 September.
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A real-time RT-PCR test, Revogene SARS-CoV-2 has been designed to detect RNA from SARS-CoV-2 in anterior nasal, nasopharyngeal, oropharyngeal and mid-turbinate nasal swab samples collected from individuals who are suspected of having Covid-19 by their healthcare provider.
It runs on the company’s Revogene platform and can provide positive results in 47 minutes.
The company stated that the test has demonstrated good clinical performance, with 97.7% of negative and positive predictive agreements.
Meridian Bioscience Diagnostics executive vice-president Tony Serafini-Lamanna said: “There continues to be demand for fast, accurate detection of Covid-19, especially considering the high transmissibility of these new variants and the upcoming respiratory season.
“We believe our Revogene SARS-CoV-2 assay and growing Revogene platform can help clinicians and health systems meet these demands now and in the future.”
The company’s fully automated Revogene molecular platform can easily integrate into any laboratory or health system and optimise the laboratory’s Covid-19 testing capacity in two steps.
Other FDA-approved tests that can run on the Revogene platform include Revogene Carba C, Revogene Strep A, Revogene C difficile and Revogene GBS LB.