Meridian Bioscience’s COVID-19 Test Authorized for Emergency Use by FDA

Meridian Bioscience has received the FDA's Emergency Use Authorization for its Revogene SARS-CoV-2 COVID-19 test.

Cincinnati, Ohio-based Meridian said it expects to begin shipping the molecular assay before the end of December.

The test can return a positive result as soon as within 47 minutes from nasopharyngeal, oropharyngeal, anterior nasal and midturbinate nasal swab specimens. It features a positive predictive agreement of 97.7 percent and a negative predictive agreement of 97.7 percent.