NEW YORK – Meridian Bioscience announced on Wednesday that its Revogene SARS-CoV-2 test has received Emergency Use Authorization from the US Food and Drug Administration.
The molecular test runs on the firm's Revogene instrument and returns positive results in 47 minutes and negative results in 70 minutes from a nasopharyngeal, oropharyngeal, anterior nasal, or mid-turbinate nasal swab. Both the test's positive and negative predictive agreements are 97.7 percent, the company said in a statement.
Cincinnati-based Meridian said it expects to begin shipping the test before the end of the calendar year.
"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," Tony Serafini-Lamanna, Meridian's executive VP for diagnostics, said in a statement. The Revogene test can help meet those demands, he added.
In February, the FDA requested additional information for Meridian's EUA application for the test, and later that month the firm announced it would withdraw its application to conduct additional studies on the test.
Meridian resubmitted its application to the FDA in June after conducting a new clinical validation study and limit-of-detection bridging study.