FDA Lists SARS-CoV-2 MDx Tests Potentially Impacted by Omicron Variant

Original from: Genomeweb

Image Credit: FR24 News

The US Food and Drug Administration said on Friday that it has updated its website tracking the potential impact of SARS-CoV-2 variants on molecular diagnostic tests to include tests likely affected by the Omicron variant.

The updated site lists 26 assays from 23 developers and manufacturers "whose performance may be impacted by mutations in the SARS-CoV-2 Omicron variant."

For each of the tests, the FDA's bioinformatics analysis suggests that one genetic target will have significantly reduced sensitivity due to a mutation in Omicron.

"A specific deletion in the spike (S) gene (Δ69-70) results in an S-gene dropout, also referred to as an S-gene target failure (SGTF), where the genetic target that covers the portion of the S-gene where the deletion occurs fails to detect the virus," the agency wrote.

The listed assays will still be able to detect SARS-CoV-2 infection, however.

"Since these tests are designed to detect multiple genetic targets, the overall test sensitivity should not be impacted," the FDA said. 

The agency recommended that clinical lab staff and healthcare providers using the listed tests be aware of the potential for SGTF.

Furthermore, as SGTF is typically not observed in the Delta variant — which is the primary variant currently circulating in the United States — specimens "with an S-gene dropout detection pattern may potentially be Omicron variants and should be prioritized for sequencing confirmation," the FDA said.

Source: FDA Lists SARS-CoV-2 MDx Tests Potentially Impacted by Omicron Variant