NEW YORK – Cepheid announced on Thursday that it has obtained the CE mark for a rapid molecular test to detect the SARS-CoV-2 virus. The new test will begin shipping this month.
Called Xpert Xpress CoV-2 plus, the new rapid molecular diagnostic test adds a third gene target to enhance detection of future viral variants and proactively address increasing genetic diversity of the virus, Cepheid said in a statement.
The test garnered Emergency Use Authorization from the US Food and Drug Administration last week.
"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," Persing added.
Xpert Xpress CoV-2 plus is authorized to test symptomatic patients as well as for screening those without symptoms or reasons to suspect COVID-19. It can provide on-demand detection of SARS-CoV-2 in as little as 20 minutes for positive results and it is designed for use on Cepheid's GeneXpert instruments, which have an installed base of more than 40,000 systems worldwide.