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.
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.