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

0

GOOD

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:5/20/2013)... GLENWOOD, Ill. , May 20, 2013 ... leader in personal and environmental radiation measurement and monitoring, ... accessories, announced today that its Board of Directors declared, ... quarterly cash dividend of $0.55 per share for the ... paid on July 3, 2013, to shareholders of record ...
(Date:5/20/2013)... , May 20, 2013   National Community ... Hoey , RPh, MBA issued the following statement ... Associates regarding Medicare Part D "preferred pharmacy" drug ... offering patients the plan,s lowest advertised co-payments: ... Medicare and MedPAC , 16 ...
(Date:5/20/2013)...  TRACE International today released its Global Enforcement ... against individuals and government or business entities for bribery ... 2012 is the third in an annual series ... "Although the number of outbound enforcement actions fell ... priority," said Alexandra Wrage , TRACE ...
Breaking Medicine Technology:Landauer, Inc. Declares Regular Cash Dividend 2Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 2Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 3Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 4TRACE Releases 2012 Global Enforcement Report 2TRACE Releases 2012 Global Enforcement Report 3
... Elsevier, the world-leading publisher of ... announced today that its 2012 eBook Frontlist collections ... Elsevier,s online platform for scientific content. This release ... depth of the eBook collection on SciVerse ScienceDirect. ...
... 2011 Baxa Corporation , a leading provider ... has released a software upgrade for its ExactaMix® ... 14 updates that provide Directors of Pharmacy with enhanced ... worldwide use ExactaMix 2400 (EM2400) and ExactaMix 1200 (EM1200) ...
Cached Medicine Technology:Elsevier Announces New 2012 Frontlist eBooks Collection on SciVerse ScienceDirect Available for Advance Purchase 2Elsevier Announces New 2012 Frontlist eBooks Collection on SciVerse ScienceDirect Available for Advance Purchase 3Baxa Corporation Bolsters Patient Safety With ExactaMix® Compounder Software Upgrade 2Baxa Corporation Bolsters Patient Safety With ExactaMix® Compounder Software Upgrade 3Baxa Corporation Bolsters Patient Safety With ExactaMix® Compounder Software Upgrade 4
(Date:5/21/2013)... 2013, PHILADELPHIA ─ The negative effects of poorly ... performance in urban schoolchildren has been confirmed in ... been recognized that missed sleep and school absences ... our study is the first to explore the ... in real time, prospectively, using both objective ...
(Date:5/21/2013)... physical activity appears to be an independent predictor ... pulmonary disease (COPD) will end up being hospitalized, ... in Connecticut. The study also corroborates an earlier ... an increased incidence of hospitalizations among patients with ... be presented at the ATS 2013 International Conference. ...
(Date:5/21/2013)... 2013, PHILADELPHIA ─ A novel approach to obstructing ... of asthma has shown promise in a Phase ... , Their research will be presented at the ... simultaneously online in the New England Journal ... trial tested the efficacy and safety of the ...
(Date:5/21/2013)... PHILADELPHIA─Treatment with an Alpha-1 proteinase inhibitor (A1-PI), a ... breakdown and protects the lung,s elasticity, is effective ... with Alpha-1 antitrypsin deficiency (AATD), a life-threatening genetic ... the 2013 American Thoracic Society International Conference. , ... the loss of lung tissue as measured by ...
(Date:5/21/2013)... After the success of its inaugural 1,000 lb. ... Body Boot Camp Goderich will be hosting its 2nd Annual ... Goderich fitness center located at 199 Anglesea Street Goderich, ... goal is to inspire and motivate local community residents to ... The fee to participate is discounted to $40 for the ...
Breaking Medicine News(10 mins):Health News:Asthma symptoms impair sleep quality and school performance in children 2Health News:Exercise levels may predict hospitalizations in COPD population 2Health News:Monoclonal antibody appears effective and safe in asthma Phase IIa trial 2Health News:Monoclonal antibody appears effective and safe in asthma Phase IIa trial 3Health News:Treatment with A1-PI slows the progression of emphysema in Alpha-1 antitrypsin deficiency 2Health News:Treatment with A1-PI slows the progression of emphysema in Alpha-1 antitrypsin deficiency 3Health News:Goderich Fitness Center Promotes 2nd Annual 1,000 lb. Meltdown Challenge to Fight Obesity With All Proceeds Raised Going to Local Charity 2Health News:Goderich Fitness Center Promotes 2nd Annual 1,000 lb. Meltdown Challenge to Fight Obesity With All Proceeds Raised Going to Local Charity 3
... of Public Health reported that most of the flu shot ... to the department, 94% of the state's total order has ... 24. Over 1.7 million vaccines will be stocked that includes ... Centers for Disease Control and Prevention revealed that this flu ...
... The World Health Organization (WHO), on Friday, had initiated the ... prevent infections associated //with Health care practices. WHO said that ... costs but also will save lives. ,It is ... by the infections caused by the hospitals, which are mainly ...
... are more likely to develop certain types of cancer ... // ,Grace LeMasters and colleagues at the ... fire fighters from 32 previously published scientific studies to ... of their profession, reported science portal EurekAlert. ...
... recent study revealed that consuming just two cups of green ... Texas in collaboration with their counterparts in the UK carried ... online edition of the Journal of Allergy and Clinical Immunology. ... (EGCG) present in green tea has the ability to block ...
... disease are alarming. According to a news release by McGill ... Canada and 8,500 deaths from the disease are expected every ... deaths, as reported by the Centers for Disease Control and ... and 16,000 deaths. ,However, here is some good ...
... the eyes can diagnose cerebral malaria in children, according ... complication where the Plasmodium falciparum parasite infects capillaries that ... to detect as patients can be unconscious and have ... ratio in cerebral malaria is 25-50 percent, reported science ...
Cached Medicine News:Health News:The Anti-HIV Properties Of Green Tea Uncovered 2
... Helmer PC1200 Platelet Incubators ... your laboratory counter top. These ... institution to have the security ... environment without taking up a ...
The PC4200i is the largest capacity platelet incubator available. It features a built-in agitator with a capacity of 396 random bags (132 apheresis)....
... rotators and agitators for continual ... set at 22C (71F) or ... (59F to 104F). Uniformity is ... bottom. Recorder is standard on ...
An enzyme-linked immuno-sorbent assay for the detection and quantitation of anti-tissue Transglutaminase in serum of patients with Celiac Disease and Dermatitis Herpetiformis....
Medicine Products: