Cepheid has announced that its Xpert Xpress CoV-2 plus test has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).
Xpert Xpress CoV-2 plus is a rapid molecular diagnostic test designed to identify the virus that causes Covid-19.
The test has been approved for use by authorised laboratories to detect nucleic acid from SARS-CoV-2.
According to the company, the new test adds a third conserved genetic target for SARS-CoV-2 detection. This will help with the detection of potential future mutations of the virus.
The Xpert Xpress CoV-2 plus test can be used to test any individual, including those without symptoms. It is designed for use on Cepheid’s GeneXpert systems and can provide results in 20 minutes.
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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 Xpert Xpress CoV-2 plus further expands Cepheid’s portfolio of PCRplus respiratory tests, which deliver rapid results.
Last October, the California-based molecular diagnostics company obtained CE mark for its Xpert Xpress CoV-2/Flu/RSV plus test.
The test is capable of detecting SARS-CoV-2, influenza virus and respiratory syncytial virus (RSV) from one patient sample.