Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform
Roche Molecular Diagnostics announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS AmpliPrep / COBAS TaqMan HCV Test for use in the United States. The test uses Roche's proprietary real-time PCR technology to quantify the amount of Hepatitis C RNA in a patient's blood. Physicians use Hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy. [more...]
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