Cepheid Announces European Launch of CE Mark Certified Smart HBV Test

Cepheid announced the European launch of the Smart HBV (hepatitis B virus) assay for clinical diagnostic use on the SmartCycler system.

The assay was released as a CE IVD Mark product, which means it met the most rigorous EU requirement, and is intended for the rapid identification of the HBV viral load, the company said.

The SmartCycler is a real-time polymerase chain reaction testing platform. It can deliver test results from biological samples in 3040 minutes, Cepheid said.

"Only the regular monitoring of HBV DNA during treatment allows the rapid detection of the resumption of viral multiplication before it continues to a cytolytic peak," Jean-Marie Seigneurin, professor of virology at the University of Grenoble, France, said.