Skip to main content
Premium Trial:

Request an Annual Quote

Meridian Biosciences SARS-CoV-2 Molecular Test May Fail With Omicron Variant, FDA Says

NEW YORK – The US Food and Drug Administration released a notice on Thursday that Meridian Biosciences' Revogene SARS-CoV-2 test is unlikely to be able to detect the Omicron variant.

As a result, the test may return false negative SARS-CoV-2 results for patients with the variant.

According to the agency, the test is expected to fail to detect the variant because of a nine-nucleotide deletion in the N-gene. The genetic target of the test covers this portion of the N gene, the FDA said, which will likely result in false negative results.

The FDA noted that the deletion is specific to Omicron, so the test's performance isn't affected by other SARS-CoV-2 variants. It added that Meridian Biosciences hasn't distributed the test in the US and doesn't intend to distribute it until the issue is resolved.

The FDA's notice about Meridian was added to a more comprehensive list of tests that could be impacted by Omicron released earlier this week. The list of 27 assays from 23 developers includes tests from Thermo Fisher Scientific, Tempus Labs, Applied DNA Sciences, and the Cleveland Clinic.

Meridian's Revogene test received Emergency Use Authorization from the FDA in November, after the firm withdrew its application in February following questions from the agency and resubmitted the test in June.

The Scan

Close Panel Vote on Califf Nomination

The New York Times reports there was a close committee vote to advance the nomination of Robert Califf to lead the US Food and Drug Administration to the full Senate.

Task Force Reports on Scientific Integrity

Nature News writes that that a new task force report recommends that the US establish a cross-agency scientific integrity council.

Across the Hall

Genetic testing, closed-circuit cameras, and more show how a traveler, without any contact, infected others at a New Zealand quarantine facility, CNN reports.

Science Paper Examines Influence of Chromatin Modifications on Obsessive-Compulsive Disorder

In Science this week: genes regulating chromatin modification may contribute to OCD risk.