Cepheid Gets EUA for Test for COVID-18, Flu, RSV
Cepheid has received an Emergency Use Authorization from the FDA for its Xpert Xpress CoV-2/Flu/RSV-plus rapid molecular diagnostic test.
The test, which can detect the viruses that cause COVID-19, Influenza A, Influenza B and respiratory syncytial virus (RSV) infections from a single patient sample, delivers results in approximately 36 minutes, according to the Sunnyvale, Calif.-based company.
Cepheid says its new version of the test includes a third gene target to detect the SARS-CoV-2 coronavirus that causes COVID-19 so that it can pick up future viral mutations. The molecular diagnostic test is designed to be used with Cepheid’s GeneXpert Systems.