FDA Expands Use for Roche's HCV RNA Diagnostic Test
Roche announced that the Food and Drug Administration (FDA) has approved its hepatitis C virus (HCV) quantitative RNA test, COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0, to aid in the diagnosis of HCV infection for certain patient populations.
A positive HCV antibody test alone does not indicate an active infection. Physicians need to diagnose an active infection by detecting the presence of HCV RNA. The COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 can now be used to confirm active hepatitis infection and accurately measure how much virus is present in the patient's blood. This expanded indication saves the physician time in making a decision regarding the course of treatment.
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The COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0, a dual-probe PCR assay, is the first quantitative HCV RNA test to be approved for use as a diagnostic aid. The test is an in vitro nucleic acid amplification test that detects and quantifies HCV RNA genotypes 1 to 6 in human EDTA plasma or serum. It is designed for use on Roche's COBAS AmpliPrep/COBAS TaqMAn System.
The COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 is already approved for use as a viral load test to help assess a patient's response to antiviral therapy
For more information call (800) 526-6367 or visit RocheUSA.com.