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Tide Labs Resolves Issue With Molecular SARS-CoV-2 Test to Detect Omicron Variant

NEW YORK – The US Food and Drug Administration announced on Monday that Tide Labs' DTPM COVID-19 RT-PCR test can now detect the Omicron variant and has been removed from its list of tests affected by the mutation.

Last week, the agency reissued the test's Emergency Use Authorization, originally issued in June 2020, after the company modified it. The original test was a single target test that was expected to miss Omicron variant due to the mutation's deletion of nine nucleotides in the N gene that the single target covered, the FDA said. 

The test is now a multiplex test with an added reverse primer to detect the variant, the agency added. Additional lab testing is ongoing as a condition of the reissued EUA, but bioinformatics analysis has demonstrated a 100 percent match with Omicron and Delta variant sequences, the FDA said.

Currently, the FDA lists two molecular tests that are expected to fail to detect the Omicron variant: Meridian Bioscience's Revogene SARS-CoV-2 test and Applied DNA Science's Linea COVID-19 Assay Kit.