Meridian’s molecular diagnostic test is now authorised for the qualitative detection of the SARS-CoV-2 virus, including its Omicron variant, using nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens
Meridian Bioscience has secured the US Food and Drug Administration (FDA) expanded the Emergency Use Authorisation (EUA) for its Revogene SARS-COV-2 molecular assay.
The US-based diagnostic solutions provider designed its molecular diagnostic test for the detection of the SARS-CoV-2 virus from nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens.
In November last year, US FDA granted emergency authorisation for Revogene SARS-CoV-2 assay, which lacked the ability to detect the Omicron variant.
As the earlier design was not capable of detecting the new variant, Meridian stopped distributing the assay to modify its design, to enable the detection of the Omicron variant.
In March this year, the company completed development work and submitted preliminary data to the FDA to validate the performance of the revised assay.
The US health agency expanded the authorisation for Revogene assay after the company completed additional clinical studies in consultation with the FDA.
Meridian is planning to commence distribution of the test before the end of the fiscal fourth quarter ending 30 September 2022.
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.”
Meridian claimed that its Revogene SARS-CoV-2 test provides superior results with a 97.7% positive predictive agreement (PPA) and 97.7% negative predicative agreement (NPA).
Its flexible Revogene molecular testing platform can easily integrate into any laboratory or health system, said the company.
The company’s other FDA-approved tests in the Revogene portfolio include Revogene C. difficile, Revogene Strep A, Revogene GBS LB, and Revogene Carba C.
Its Revogene SARS-CoV-2 assay will help improve the Covid-19 testing capacity of labs and healthcare systems, and enable healthcare providers to rapidly deliver the care, said Meridian.
Last month, a consortium of newly formed affiliates of SD Biosensor and SJL Partners agreed to acquire Meridian Bioscience in an all-cash transaction valued at around $1.53bn.