Roche's hepatitis C virus tests get US marketing ok

The US Food and Drug Administration has granted marketing approval toRoche Diagnostics for two hepatitis C virus tests designed to directly detect the presence of HCV in patients who have evidence of liver disease and antibody evidence and who are suspected to be actively-infected.

Roche says that its Amplicor HCV Test, version 2.0, and the Cobas Amplicor HCV Test, version 2.0, are the first qualitative RNA tests for HCV to be approved by the FDA. It adds that Amplicor uses polymerase chain reaction technology to detect the hepatitis C viral RNA.