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FDA Reissues EUA for Meridian Bioscience COVID-19 Test After Omicron Variant Trouble

NEW YORK — Meridian Bioscience said on Friday that the Emergency Use Authorization for its Revogene SARS-CoV-2 molecular test has been reissued by the US Food and Drug Administration.

The test, which runs on the firm's Revogene instrument and which Meridian originally said returns positive results in 47 minutes and negative results in 70 minutes from a nasopharyngeal, oropharyngeal, anterior nasal, or mid-turbinate nasal swab, first received EUA from the FDA in November.

However, Meridian held off on launching the test when it was discovered that the assay would not detect the Omicron SARS-CoV-2 variant. Following updates to the test to enable detection of the variant and the completion of additional clinical testing, the FDA has reauthorized the EUA, the Cincinnati-based company said.

Meridian said that it expects to begin shipping the test before the end of September.

Meridian isn’t the only company to find that its SARS-CoV-2 test couldn't detect Omicron. In 2021, Tide Labs had to make changes to its DTPM COVID-19 RT-PCR test to ensure it could detect the variant.