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.