Roche Hepatitis C PCR test
This article was originally published in The Gray Sheet
FDA grants Roche Molecular Systems expedited review for the Amplicor HCV test version 2.0 and Cobas Amplicor HCV test version 2.0, designed to directly detect the presence of hepatitis C virus "due to the recognized public health problems" and "the lack of standardized HCV RNA tests," Roche announces April 17. The two tests are the first qualitative RNA tests to be submitted for agency review
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