FDA says COVID-19 tests not likely to be impacted by Omicron

Dec. 1, 2021

The U.S. Food and Drug Administration (FDA) said a preliminary review shows that high-volume polymerase chain reaction (PCR) and antigen (rapid) tests have a low likelihood of being impacted by Omicron, and the tests should continue to work.

However, the FDA said it will continue to monitor the performance of these assays.

The FDA’s Acting Commissioner Janet Woodcock, MD, made those pronouncements as part of an official statement the agency released about Omicron, which is the SARS-CoV-2 variant first detected in South Africa. The World Health Organization (WHO) has classified Omicron as a variant of concern.

“The FDA has been actively monitoring for the possible emergence of SARS-CoV-2 variants since early in the pandemic and has worked with medical product developers when a new variant (or mutation) emerges that could impact product performance,” Woodcock said.

In addition to diagnostics, the FDA also is evaluating the impact of Omicron on therapeutics and vaccines. Woodcock also said the FDA expects to have more information about how well current vaccines work against the new variant in a few weeks.

In separate announcements related to the new variant, Abbott and BD (Becton, Dickinson and Company) expressed confidence that their SARS-CoV-2 tests will continue to detect the virus.

“While the Omicron variant contains mutations to the spike protein, Abbott's rapid and molecular tests – antigen and PCR – do not rely on the spike gene to detect the virus,” Abbott said.

Meanwhile, Dave Hickey, President of Life Sciences for BD, said the company “has conducted an analysis of the recently identified Omicron variant of concern, and we are confident that our rapid antigen and PCR tests for COVID-19 will detect the novel variant.”

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