FDA approves first RNA-based HCV (hepatitis C virus) tests
This article was originally published in Clinica
Executive Summary
The FDA has approved the first qualitative RNA tests for sale in the US. Roche Diagnostics' Amplicor HCV Test, version 2.0, and Cobas Amplicor HCV Test, version 2.0 have gained market go-ahead for the direct detection of hepatitis C virus in patients who have evidence of liver disease and antibody evidence of HCV infection.