The firm has added a third gene target to the new "plus" version of the test to help detect future SARS-CoV-2 mutations and optimise nucleocapsid gene probes
Cepheid secured the Emergency Use Authorization (EUA) for its Xpert Xpress CoV-2 plus test. (Credit: Cepheid)
US-based molecular diagnostics company Cepheid has secured the emergency use authorization (EUA) from the Food and Drug Administration (FDA) for its Xpert Xpress CoV-2 plus test.
The Xpert Xpress CoV-2 plus, a rapid molecular diagnostic test, is intended for the qualitative detection of the COVID-19 virus.
The latest product joins the Xpert Xpress CoV-2/Flu/RSV plus and other PCRplus respiratory tests in Cepheid’s growing line of tests for speedy, accurate, and actionable respiratory results.
The firm said that the Xpert Xpress CoV-2/Flu/RSV plus is suitable against viruses that cause influenza-like diseases.
To tackle the challenge of future viral alterations, the new plus version of the test adds a third conserved genetic target for SARS-CoV-2 identification and optimises nucleocapsid gene probes for consistent virus detection.
Cepheid chief scientific officer David Persing said: “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.
“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.”
The FDA’s approval cleared the usage of Xpert Xpress CoV2 plus on any individual, including those who have no symptoms or grounds to suspect COVID-19.
It is compatible for use on any of the 40,000 Cepheid’s GeneXpert systems present all over the world and can yield rapid on-demand detection of SARS-CoV-2 in 20 minutes for positive results, the firm said.
In October last year, Cepheid received the CE mark for its Xpert Xpress CoV-2/Flu/RSV plus.