Diagnostics

First Tests To Detect Hepatitis C Virus RNA Approved

Published in Medical Letter on the CDC and FDA, August 19th, 2001

Roche's qualitative Amplicor^R hepatitis C virus (HCV) tests could bring more accurate identification of liver disease to the clinical setting.

Roche Diagnostics Corporation announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for two hepatitis C tests designed to directly detect the presence of the HCV in patients who have evidence of liver disease and antibody evidence of HCV and who are suspected of being actively infected with HCV. The Amplicor HCV Test, version 2.0, and the COBAS Amplicor HCV Test, version 2.0, are the first qualitative RNA tests to be approved for marketing by the FDA.

"As the...

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Source: Medical Letter on the CDC and FDA (2001-08-19)

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