FDA Gives Approval for Cepheids’ Hepatitis C Test

The Danaher subsidiary Cepheid received de novo licence from the FDA to use a point-of-care molecular check for the detection of the hepatitis C virus.

The FDA released a statement announcing that the Xpert HCV test, which utilises the company’s GeneXpert Xpress platform, can identify hepatitis C RNA from a fingerstick sample of blood and provides findings in approximately one hour.

Adults who exhibit hepatitis C symptoms or whoever possess a risk for the illness should be tested. It is not designed to be used for tissue, plasma, or blood donor testing or for tracking patients during therapy.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health commented: “Equipping healthcare providers with tools to diagnose and treat patients in the same visit can result in hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing individual disease progression and additional spread of the virus.”