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Cepheid Adds New Gene Target to SARS-CoV-2 Molecular Test to Account for Variants

NEW YORK – Danaher subsidiary Cepheid announced on Thursday that its Xpert Xpress CoV-2 plus test has received Emergency Use Authorization from the US Food and Drug Administration.

The test, a new version of the company's original Xpert Xpress CoV-2 test, includes a new third conserved gene target for the SARS-CoV-2 virus to proactively address the increasing genetic diversity of SARS-CoV-2. The test "optimizes nucleocapsid gene probes to enable consistent virus detection," Cepheid said in a statement. 

The assay runs on Cepheid's GeneXpert systems and provides positive results in about 20 minutes. It is expected to begin shipping in the US this month. 

"From the beginning of the pandemic, we have been keenly focused on staying ahead of SARS-CoV-2 genetic drift and have designed our tests in anticipation of current and potential future variants," Cepheid CSO David Persing said in a statement. "The high sensitivity of this test is now especially important for recently announced Test-to-Treat initiatives, for which early detection is important for achieving the best clinical outcomes of antiviral therapies."

SARS-CoV-2 variants have caused concerns for some manufacturers of both rapid antigen and molecular tests about the effectiveness of their assays when a new variant emerges. In December, the FDA released a list of molecular tests that may have been affected by the Omicron variant, and companies like Meridian Bioscience have pulled their molecular tests to conduct additional studies to ensure their ability to detect variants.