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® HBV
Applicant: Roche Molecular Systems, Inc.
Address: 4300 Hacienda Drive, Pleasanton, CA 94588
Approval Date: October 14, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150014a.pdf
What is it? The cobas® HBV is a laboratory test used to measure the amount of hepatitis B virus (HBV) DNA (deoxyribonucleic acid) in patient’s blood. Viral DNA is genetic material from HBV.
Hepatitis B is a liver infection caused by HBV. Hepatitis B is transmitted when blood or another body fluid from a person infected with the Hepatitis B virus enters the body of someone who is not infected. This can happen through sexual contact; sharing needles, syringes, or other drug-injection equipment; or from mother to baby at birth. For some people, hepatitis B is an acute, or short-term, illness but for others, it can become a long-term, chronic infection. Risk for chronic infection is related to age at infection: approximately 90% of infected infants become chronically infected, compared with 2%–6% of adults. Chronic Hepatitis B can lead to serious health issues, like cirrhosis or liver cancer.
The results from the cobas® HBV 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 (DNA) is automatically separated from serum or EDTA plasma using the cobas® 6800 or8800 Systems. Separated DNA is mixed with the assay reagents. The cobas® 6800/8800 Systems calculate the amount of HBV DNA in the patient’s blood based on the fluorescent signal measured by the analyzer during polymerase chain reaction (PCR). Measurement of the amount of HBV DNA 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 determine whether a person has active HBV infection and to evaluate the patient’s response to treatment.
When should it not be used? The cobas® HBV should not be used if it is not ordered by a physician. It should not be used to screen blood or blood products for transfusion. The assay should not be used to determine if a person is infected with the hepatitis B virus or to determine the stage of HBV infection. It should not be used to predict the outcome of anti-viral treatment.
Additional information (including warnings, precautions and adverse events): The Summary of Safety and Effectiveness Data and labeling are available online.