Navigation Links
Roche Receives FDA Approval for Second-Generation Hepatitis B Viral Load Test
Date:9/22/2010

PLEASANTON, Calif., Sept. 22 /PRNewswire-FirstCall/ -- Roche Molecular Diagnostics (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food & Drug Administration (FDA) has approved the COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0 for use in the United States. The new Roche test provides a fully automated solution for the quantitative detection of hepatitis B virus (HBV) DNA in human plasma or serum for patients on HBV antiviral therapy.  

"This new test enables clinicians to follow best practices in patient care with standardized viral load measurements, a broad range of detection, and high sensitivity," said Paul Brown, Ph.D., President and CEO of Roche Molecular Diagnostics. "The system is also carefully designed to protect the integrity of each patient result, so clinicians can make key medical decisions about therapy with confidence."

According to the Centers for Disease Control, an estimated 1.2 million people in the United States are living with chronic hepatitis B. Clinical practice guidelines for chronic HBV highlight the importance of monitoring the levels of circulating hepatitis B viral DNA as an indicator of when hepatitis B therapies should be started, and to measure response to treatment, including suppression of HBV replication.

"Viral load testing remains the gold-standard for the management of HBV antiviral therapy," said Teresa Wright, MD, Chief Medical Officer of Roche Molecular Diagnostics. "Roche's new HBV test provides accurate and reproducible results at the key medical decision points, allowing the clinician to optimize patient outcomes."

About the COBAS® AmpliPrep/COBAS® TaqMan® HBV Test v2.0 The Roche COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0 has been validated to quantify diverse samples from genotypes A-H and pre-core mutants across a broad linear dynamic range of 20 IU/mL to 1.7E+08 IU/mL. The new assay uses a reduced sample input volume of 650 uL of either serum or plasma specimens and is standardized against the World Health Organization (WHO) Standard for hepatitis B.

This test is designed for use on Roche's fully automated COBAS® AmpliPrep/COBAS® TaqMan® System that is used in more than 250 clinical laboratories across the U.S.

The platform combines the COBAS® AmpliPrep Instrument for automated sample preparation and the COBAS® TaqMan® Analyzer or the smaller COBAS® TaqMan® 48 Analyzer for automated real-time PCR amplification and detection.

"Sample in/results out" testing eliminates manual intervention between steps and configuration options allow for customizable solutions for throughput needs. For a flexible throughput solution, the test offers 72 tests per kit in self sealing, ready-to-use reagent cassettes. Roche's proprietary AmpErase enzymes are also included in each test and are designed to prevent cross-contamination of samples and labs.

About Hepatitis B Approximately 4,500 cases of acute hepatitis B in the United States are reported to CDC each year and each year an estimated 43,000 persons are newly infected with HBV.(1) However, because many HBV infections are either asymptomatic or never reported, the actual number of new infections is estimated to be approximately tenfold higher.  

The hepatitis B virus is spread through having unprotected sex, by sharing needles, or from an infected mother to her baby during child birth. Symptoms occur in about 70 percent of patients and include jaundice, fatigue, abdominal pain, loss of appetite, nausea and vomiting.  

About RocheHeadquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.(1)

Centers for Disease Control.  http://cdc.gov/hepatitis/HBVAll trademarks used or mentioned in this release are legally protected by law.

For further information please contact: Jessica E. BrillantMolecular Diagnostics Communication925.730.8503
'/>"/>

SOURCE Roche Molecular Diagnostics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AstraZeneca Joins Rochester Initiative to Further Cardiac Safety
2. Roche Launches New Initiative - Roche Goes to Town
3. Roche Diagnostics Introduces Full Line of 9-Minute STAT Assays for Cardiac Biomarker Testing on cobas 6000 Analyzer Series
4. Roche Receives FDA Clearance for U.S. Launch of cobas 8000 Modular Analyzer Series for High-Volume Laboratory Testing
5. New England Biolabs Launches NEBNext™ Quick DNA Sample Prep Reagent Sets for Use With Roche/454 Next Generation Sequencing Platforms
6. caprotec bioanalytics Announces the Successful Completion of a Collaborative Research Project With Roche
7. Rochester Medical Corporation Honored by Premier Healthcare Alliance for Exceptional Supplier Performance
8. Roche Holds Seventh Annual Childrens Walk
9. Roche Symposium Showcases Accomplishments of Next Generation of Chemists
10. ThromboGenics and BioInvent to Receive EUR10 Million Milestone as Partner Roche Begins New Clinical Study with TB-403
11. Roche Women Honored as 2010 TWIN Awardees
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, ... design, development and manufacturing of collagen and mineral ... announced today that Bill Messer has ... Marketing to further leverage the growing portfolio of ... devices. Bill joins the Collagen Matrix ...
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... 2016   Pulmatrix, Inc ., (NASDAQ: ... drugs, announced today that it was added to the ... its comprehensive set of U.S. and global equity indexes ... important milestone for Pulmatrix," said Chief Executive Officer ... our progress in developing drugs for crucial unmet medical ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... that was developed to enhance the health of felines. The formula is all-natural and ... main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are ...
(Date:6/25/2016)... ... , ... Austin residents seeking Mohs surgery services, can now turn to Dr. ... Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include ... in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
Breaking Medicine News(10 mins):