Cepheid this week announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert Flu/RSV XC, an on-demand molecular test for diagnosis of Flu A, Flu B, and differentiation of RSV infection.
The assay runs on Cepheid’s GeneXpert System, which has a worldwide install base of more than 7,500 systems.
Upper respiratory infections are one of the most common reasons for doctor and hospital visits and, in the United States, are the most common illness leading to school or work absences. Early symptoms for a wide variety of viral and bacterial respiratory infections are similar, yet treatment is different depending on the cause of infection.
With Xpert Flu/RSV XC, hospitals and clinicians can reliably diagnose and differentiate influenza strains and RSV in real-time.
“Influenza strains are notoriously unpredictable and the severity of flu outbreaks can vary widely from season to season,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “Recent media coverage of serious viruses such as Enterovirus D68 and Ebola have raised public awareness, and created a greater need for healthcare workers to deliver timely and accurate test results for flu or RSV infection.”
Source: Cepheid press release, adapted. Xpert and GeneXpert are registered, protected terms by Cepheid.