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 vol
'/>"/>

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

Page: 1 2 3

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:9/30/2014)... , Sept. 30, 2014 This ... for molecular imaging informatics solutions including nuclear imaging ... and comparison. The study assesses the size of ... 2010 and 2013, and projects future growth based ... as the dynamics taking place in the broader ...
(Date:9/30/2014)... BURLINGTON, Mass. , Sept. 30, 2014  Decision ... (PV) devices in Brazil , ... and China (BRIC) will see ... techniques are increasingly favored over surgical procedures. Although revenues ... care resources, reimbursement challenges, prolonged device approval times and ...
(Date:9/30/2014)... 2014  Alimera Sciences, Inc. (NASDAQ: ALIM ... research, development and commercialization of prescription ophthalmic pharmaceuticals, announced ... from Hercules Technology Growth Capital, Inc. (NYSE: ... final advance under the Loan and Security Agreement that ... , Alimera Sciences Limited, entered into with Hercules in ...
Breaking Medicine Technology:Analysis of the US Molecular Imaging Informatics Market 2Analysis of the US Molecular Imaging Informatics Market 3Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 2Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 3Alimera Sciences Receives $25 Million Advance from Hercules Technology Growth Capital 2
... Planet Biopharmaceuticals, Inc. and its wholly owned Subsidiaries ... on providing products for allergy and asthma sufferers, today ... ALLERGY CONTROL PRODUCTS, INC., a Delaware corporation("ACP") to RH ... Theron E. Odlaug, Ph. D., CEO and ...
... Communication efforts on behalf of the public and private healthcare ... are today, according to a new book , "Health ... Nancy J. Hicks and Christina Mazzola Nicols of Ketchum ... The book, released this fall from Jones & ...
Cached Medicine Technology:New Book Highlights Opportunities for Healthcare Industry Communications 2New Book Highlights Opportunities for Healthcare Industry Communications 3New Book Highlights Opportunities for Healthcare Industry Communications 4New Book Highlights Opportunities for Healthcare Industry Communications 5
(Date:10/1/2014)... Nev. (PRWEB) October 01, 2014 First ... measuring abnormal circadian cellular changes throughout the body, announced ... Inc. to better address the company’s breadth of upcoming ... early breast cancer screening technology. , “Our initial focus ... cancer system which detects abnormal circadian cellular changes over ...
(Date:10/1/2014)... finding from Duke Medicine suggests that some people who ... be hard-wired to gain weight when exposed to chronic ... estimated 13 percent of people, all of whom are ... could help them reduce heart disease with simple interventions ... , "Genetic susceptibility, psychosocial stress and metabolic factors act ...
(Date:10/1/2014)... Inc., announced today their new NoteSwift™ 2.0 for Allscripts ... the bridge between the EHR and Dragon Medical interpreting ... at the point of care. NoteSwift reduces the time ... than half – and virtually eliminates mouse clicks – ... EHR use according to the June 12, 2014 HIMSS ...
(Date:10/1/2014)... Nordic Naturals is kicking off a ... The campaign—“Buy One Bottle. Help Two Heroes.”—will raise ... nonprofit organization that helps rebuild the lives of ... would otherwise face euthanasia. From October through December ... donations of Nordic Naturals omega-3s to veterans and ...
(Date:10/1/2014)... Blaine, WA (PRWEB) October 01, 2014 ... that will take them across the country in an ... of today’s military families. The cyclists, a father-daughter ... 12 states, beginning in Blaine, Washington and finishing in ... will benefit Hope For The Warriors®, a national nonprofit ...
Breaking Medicine News(10 mins):Health News:First Warning Systems Changes Name to Cyrcadia Health to Better Reflect Core Competency and Goals of Company 2Health News:First Warning Systems Changes Name to Cyrcadia Health to Better Reflect Core Competency and Goals of Company 3Health News:First Warning Systems Changes Name to Cyrcadia Health to Better Reflect Core Competency and Goals of Company 4Health News:Gene interacts with stress and leads to heart disease in some people 2Health News:NoteSwift Joins Allscripts Developer Program 2Health News:NoteSwift Joins Allscripts Developer Program 3Health News:Nordic Naturals® Inspires Support for Paws for Veterans -- ‘Buy One Bottle. Help Two Heroes.’ Initiative Kicks Off October 1 2Health News:Father-Daughter Cycling Duo to Ride Cross-Country to Benefit Hope For The Warriors 2
... said that fish was capable of scaling down the risk ... fish do not serve to reduce cancer risk, according to ... // witnessed in the case of people who consume large ... have attempted to assess the effects of omega-3 fatty acids ...
... health department officials have proposed the administration of flu vaccine ... in an attempt to prevent the incidence of seasonal flu. ... the population during winter, had claimed the valuable lives of ... Committee on Vaccination and Immunisation that addresses important medical issues ...
... to start “Hope Lodges” near major cancer hospitals to ... getting treatment in these major cancer hospitals//. ... patients who are coming from far off distances to ... facilities to these patients during their treatment which would ...
... Health Systems Association has launched a hospital information website ... of treatment// offered by the hospital which would help ... for their treatment. ,There are 35 State ... about the number of patients visiting the hospital, specialization ...
... his post-doc Chengcheng Zhang from Whitehead Institute for Biomedical Research ... enriches and increases the number of stem cells in the ... ,Stem cell therapy as shown that the quantity ... and it requires isolating large number of stem cells. Stem ...
... restored to their respective mothers, after they were swapped due to ... Jan 17, two women delivered surgical babies in the Ranchi Institute ... to a daughter at 10.30 p.m. and Meena Devi gave birth ... half an hour before I. When Savitri was shifted to my ...
Cached Medicine News:
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: