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:12/24/2014)... 2014  Actavis plc (NYSE: ACT ... a complete response letter from the U.S. Food ... Application (NDA) for the fixed-dose combination (FDC) of ... Photo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO ... receipt of a complete response letter, Actavis remains ...
(Date:12/24/2014)... Dec. 24, 2014 Kinex Pharmaceuticals announced today ... at Roswell Park Cancer Institute. KX2-361 (KX02), ... that has shown potent inhibitory activity against a broad ... are resistant to Temozolomide (T98G), the most widely used ... well-established brain tumor mouse model, KX2-361 consistently clears brain ...
(Date:12/24/2014)... Dec. 24, 2014  Conkwest, Inc., the Natural ... proprietary Natural Killer (NK) cell-line platform, Neukoplast® (NK-92™) ... Patrick Soon-Shiong , NantWorks founder, physician scientist and ... to purchase approximately $48 million of the Company,s ... investment, he will be named Co-Chairman of the ...
Breaking Medicine Technology:Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension 2Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension 3Actavis Confirms Complete Response Letter for Nebivolol/Valsartan Fixed-Dose Combination for Hypertension 4Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 2Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 3Conkwest Announces $50m In Strategic Investments And Appoints NantWorks Founder, Dr. Patrick Soon-Shiong As Co-Chairman Of The Board 2Conkwest Announces $50m In Strategic Investments And Appoints NantWorks Founder, Dr. Patrick Soon-Shiong As Co-Chairman Of The Board 3Conkwest Announces $50m In Strategic Investments And Appoints NantWorks Founder, Dr. Patrick Soon-Shiong As Co-Chairman Of The Board 4Conkwest Announces $50m In Strategic Investments And Appoints NantWorks Founder, Dr. Patrick Soon-Shiong As Co-Chairman Of The Board 5
(Date:12/26/2014)... (PRWEB) December 26, 2014 Parker ... for the best in heating, cooling and plumbing ... 24 hour emergency services in 2014 with regard ... know that Arizona is known for its incredibly ... that understands the intricacies and details of a ...
(Date:12/25/2014)... (PRWEB) December 26, 2014 ... BambooFlooringChina.com combines beauty, strength and durability. Today, the ... promotion, which is valid until Jan. 30, 2015. ... grain of traditional hardwood. BambooFlooringChina.com is a well-known ... help consumers worldwide to find a reliable bamboo ...
(Date:12/25/2014)... 25, 2014 Product liability lawsuits filed ... recall ( http://www.consumerinjurylawyers.com/DePuy/ ) continue to move forward in ... Order issued in the U.S. District Court, Northern District ... an open conference on January 7, 2015, at the ... in West Palm Beach, Florida. The Conference is scheduled ...
(Date:12/25/2014)... Recently, Dylan Queen, a famous online company ... collection of discounted prom dresses, most of which are ... of the company, the promotion is valid until Jan. ... expand the UK market. , The prom dresses in ... and styles: A-line strapless, empire strapless chiffon, one shoulder, ...
(Date:12/25/2014)... 2014 BambooFlooringChina.com sells many bamboo products ... flooring. Today, the company announces big discounts on ... and colors. , BambooFlooringChina.com is the world’s leader in ... is valid until Jan. 20, 2015. , The bamboo ... with a natural thread. All the bamboo strips for ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2
... on the Vine Varieties not Subject to Salmonella ... ... brand, and is North America,s largest grower of greenhouse,tomatoes, wants to let consumers ... US are not subject to the most recent June,7, 2008 Salmonella alert issued ...
... ST. LOUIS, June 9 ETHEX Corporation announced today,that ... sulfate 60 mg,extended release tablets (Lot No. 91762) due ... thickness. Oversized tablets may contain as much as,two times ... was,distributed by ETHEX Corporation under an "ETHEX" label between ...
... parasite, a team of researchers has been able to ... has thereby broken the cycle of infection during recent ... parasite through gene knock-out technol-ogy, a research team consisting ... Hopkins University, Baltimore, has prevented the parasite from going ...
... both genders over 25-year period , , MONDAY, June 9 ... arteries work just as well in women as in men, ... recent years, new research finds. , The study in the ... College of Cardiology is a marker in a fading ...
... Sen. Max Baucus,(D-MT), chair of the Senate ... bill that includes pharmacy-related provisions to provide ... claims and delay the,implementation of Medicaid reimbursement ... Roberts, RPh, executive vice president and CEO ...
... ALBANY, Ore., June 9 Synthetech, Inc. (OTC,Bulletin ... 2008 Dr. Gregory R.,Hahn will become Synthetech,s President ... has served as Synthetech,s President and Chief,Operating Officer. ... Dr.,Daniel T. Fagan, who will continue as Synthetech,s ...
Cached Medicine News:Health News:Consumers Can Purchase Majority of Tomato Varieties 2Health News:ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets 2Health News:ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets 3Health News:Researchers block transmission of malaria in animal tests 2Health News:Researchers block transmission of malaria in animal tests 3Health News:Artery-Opening Method Works Well in Women 2Health News:Artery-Opening Method Works Well in Women 3Health News:NCPA Statement on Sen. Baucus' Medicare Bill Inclusion of Solutions for Medicare and Medicaid Reimbursement Problems 2Health News:Synthetech Announces Appointment of Dr. Gregory R. Hahn as President and Chief Executive Officer 2Health News:Synthetech Announces Appointment of Dr. Gregory R. Hahn as President and Chief Executive Officer 3
... 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 ...
... 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 ...
... 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 ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: