FDA Approves Hepatitis B Viral DNA Test
Posted on: Thursday, 4 September 2008, 15:00 CDT
The U.S. Food and Drug Administration has approved the first hepatitis B nucleic acid test that measures the amount of viral DNA in a patient's blood.
The FDA said assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.
"The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum," the federal agency said. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual's response to therapy.
"Measuring a patient's HBV viral load is an important aspect of managing chronic hepatitis B infections," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "The COBAS TaqMan test gives health care providers a new and sensitive tool for this process."
The newly approved test is manufactured by Roche Diagnostics of Basel, Switzerland.
Source: United Press International
Related Articles
- New Report Calls Lab, Diagnostic Tests Critical to Health Reform Goals
- Dialysis Is Safe For Kidney Patients' Heart Health
- No Regrets Over Handling of Cancer Test Errors, Ex-N.L. Health Minister Says
- Microsoft Launches Fund to Enable Patient-Centric Health Solutions
- ViraCor Laboratories Is First National Reference Laboratory To Offer Novel Respiratory Viral Testing
- Patient Personal Health Records Have Become Reality Through Provider Endorsed Web-Based System
- Study Finds Amendment 2 Will Benefit Hundreds of Thousands of Patients, Reduce Health Care Costs and Boost Economy
- WellPoint's East Region Reports Strong, Rapid Growth With Innovative Quality Program Rewarding Hospitals for Patient Safety, Health Outcomes and Satisfaction
- The American Red Cross, Penn-Jersey Region is Offering State-of-the-Art Testing for DNA Molecular Genotyping
- Health Hero Network Unveils Health Buddy 2, Opens Next Phase in Transformation of Relationship Between Patients and Health Care
 |
 |
User Comments (0)
RSS Feeds