Meridian Bioscience has obtained emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Revogene SARS-CoV-2 assay.
The latest move comes after the company re-submitted its EUA application for the SARS-CoV-2 molecular diagnostic test in June.
The molecular test runs on the company’s Revogene platform and provides positive results in 47 minutes.
It returns test results from anterior nasal, nasopharyngeal, oropharyngeal and mid-turbinate nasal swab samples.
Meridian stated that the Revogene SARS-CoV-2 test provides positive and negative percentage agreements of 97.7%.
Additionally, the assay helps healthcare systems and laboratories to improve their testing capacity for Covid-19 and allows healthcare providers to deliver appropriate care and infection control treatment for patients.
Meridian Bioscience diagnostics executive vice-president Tony Serafini-Lamanna said: “There continues to be high demand for fast, accurate detection of Covid-19 especially considering the upcoming respiratory season and combating the Covid-19 variants that continue to emerge.
“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 Bioscience stated that its assay has been granted EUA by the FDA for use by authorised laboratories and only to detect nucleic acid from the SARS-CoV-2 virus.
It plans to commence shipping of the product before the end of its fiscal first quarter, which is 31 December 2021.
Furthermore, the Revogene flexible testing platform can be easily integrated into any health system or laboratory.
Last month, Meridian Bioscience launched its new Air-Dryable Direct RNA/DNA qPCR Blood Mix, designed to develop molecular diagnostic assays which are stable at room temperature.