This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: COBAS TaqMan HCV Test For Use With the COBAS AmpliPrep Instrument and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer
PMA Applicant: Roche Molecular Systems, Inc. (RMS)
Address: Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588
Approval Date: October 30, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060030a.pdf
What is it? This laboratory test measures the amount of hepatitis C viral RNA in a patient’s blood. Viral RNA (ribonucleic acid) is genetic material from the hepatitis C virus. The individual’s hepatitis C viral RNA load is measured before beginning treatment, and during treatment to predict and assess an individual’s response to the treatment. This test is used with the Roche COBAS TaqMan Analyzer for automated amplification and detection. The results from the COBAS TaqMan HCV Test must be interpreted within the context of all other relevant clinical and laboratory findings.
How does it work? A sample of a patient’s blood is obtained and sent to a clinical laboratory. Nucleic acid (RNA) is automatically separated from the cells in the blood sample using the COBAS AmpliPrep instrument. Separated RNA is mixed with the assay reagents and the resulting mixture put into the COBAS TaqMan Analyzer. The COBAS TaqMan Analyzer calculates the amount of HCV RNA in the patient’s blood based on the amount of produced light measured by the analyzer after completion of the reaction. Measurement of the amount of HCV RNA in the blood together with clinical presentation and other laboratory findings is used by physicians to help determine an individual’s response to treatment.
When is it used? This test is used together with other laboratory results and clinical information to evaluate the treatment of an individual infected with the hepatitis C virus.
What will it accomplish? Test results help predict an individual’s response to treatment and aid in the management of patients with HCV infection undergoing anti-viral therapy.
When should it not be used? This lab test should not be used if it is not ordered by a physician. The assay should not be used to determine if a person is infected with the hepatitis C virus. It should not be used to screen blood or blood products for transfusion.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P060030