The latest information on the potential impact of the omicron variant; update on the Meridian Bioscience, Inc. Revogene SARS-CoV-2 test

If your email program has trouble displaying this email, view as a webpage. Update: SARS-CoV-2 Omicron Variant: Impact on COVID-19 Tests Today, the U.S. Food and Drug Administration (FDA) updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information. The update added new information about: The Meridian Bioscience, Inc. Revogene SARS-CoV-2 test, including: The impact of the SARS-CoV-2 omicron variant on test performance. Since the Revogene SARS-CoV-2 test is a single target test that targets a portion of the N-gene where deletions occur with the omicron variant, the test is expected to fail to detect the SARS-CoV-2 omicron variant. Meridian Biosciences has not yet distributed this test and does not intend to distribute this test, within or outside the United States, until this issue is resolved. Read More Questions? If you have questions about this update, email COVID19DX@fda.hhs.gov.

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