Navigation Links
Roche Receives FDA Approval for Acute Hepatitis B Test
Date:10/31/2011

INDIANAPOLIS, Oct. 31, 2011 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) granted Premarket Approval (PMA) for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay for use on the cobas e 601 analyzer, the immunoassay module of the cobas® 6000 analyzer series for mid-volume laboratories. The test represents the final component of the acute panel within the hepatitis test menu for the cobas 6000 series.

The Anti-HBc IgM assay is used for the in-vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma.  The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of an acute or recent hepatitis B virus (HBV) infection.* The assay is intended for use with Roche's electrochemiluminescence (ECL) technology, a highly sensitive light detection system that provides excellent low-end sensitivity and broad dynamic measuring ranges.

With this approval, Roche now offers a full selection of hepatitis tests in its immunoassay portfolio:  HBsAg, HBsAg Confirmatory, Anti-HBs, Anti-HCV, Anti-HAV, Anti-HAV IgM, Anti-HBc IgM (approved for cobas e 601 analyzer) and Anti-HBc (approved for MODULAR ANALYTICS E170 analyzer). The combination of full hepatitis menu with the lowest assay duration on the market, the broadest integrated menu and ECL technology allows the Roche total solution to inspire confidence in the laboratory environment. The Anti-HBc IgM assay is also pending FDA approval for use on Roche's cobas e 411 and MODULAR ANALYTICS E170 analyzers. Roche's current analyzer portfolio offers labs short assay duration (9 to 27 minutes) and the broadest test menu available on an integrated platform.  

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 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 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 or www.roche-diagnostics.us.

*The Elecsys Anti-HBc Igm immunoassay's performance has not been established for the monitoring of HBV disease or therapy.

All trademarks used or mentioned in this release are protected by law.

For further information, please contact: Betsy Cox Director, Corporate Communications

Roche Diagnostics Corporation

Indianapolis, IN(317) 521-3911betsy.cox@roche.com
'/>"/>

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

Related medicine technology :

1. Wyeths Torisel and Roche/Genentechs Avastin Will Challenge Pfizers Sutent to Become the Clinical Gold Standard for Treatment of Metastatic Renal Cell Carcinoma
2. Researchers Identify Virus Possibly Responsible for Declining Honeybee Population Using 454 Sequencing Technology from Roche
3. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
4. MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera
5. Roche Announces Positive Results in Solid Tumors Using Human Monoclonal Antibody Against IGF-1R (R1507)
6. Roche Diagnostics HIV Viral Load Test Used in Clinical Trials for Isentress, a New Class of HIV Drug
7. Roches Investigational Polymerase Inhibitor, Combined with PEGASYS(R) and COPEGUS(TM), Shows Potent Antiviral Activity in Treatment of Chronic Hepatitis C at Four Weeks
8. Two Pivotal Phase III Studies for Roches ACTEMRA(TM) (tocilizumab) Demonstrate Significant Improvement in Rheumatoid Arthritis Symptoms
9. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
10. Roche responds to announcement of IDEAL hepatitis C trial results
11. Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/5/2017)...  Just 18 months after its February 2016 launch, ... the appointment of three new senior people to its ... Jones-Phillips and James Wright bring decades ... Tammy Wynne joins as Director, ... She has over ten years, experience in global market ...
(Date:9/1/2017)... Sept. 1, 2017 Michael Penna , ... , highlights opportunities for growth in his response to ... Marlin Equity is seeking a buyer for eMDs. Penna,s ... 22-year-old healthcare solutions Value Added Reseller and national leader ... "As the healthcare market continues to ...
(Date:9/1/2017)... , Sept. 1, 2017  Bayer will present the ... European Society for Medical Oncology (ESMO) 2017 Congress, September 8-12 ... will include new preclinical and clinical data on Bayer,s marketed ... earlier pipeline projects. ... best minds in cancer research at ESMO," said Carsten ...
Breaking Medicine Technology:
(Date:9/20/2017)... ... ... Houston, Texas, investment firm CORDA Investment Management, LLC, believes in giving back. ... work and rolled up their sleeves to help with relief efforts. The team picked ... process of rebuilding. , CORDA founder Bonner C. Barnes notes that investment management firms ...
(Date:9/20/2017)... ... September 20, 2017 , ... “The Financial Favor of God; Second ... of God; Second Edition” is the creation of published author, Brooks Rathell. , “We ... to talk to you about the financial favor of God. Not only does it ...
(Date:9/19/2017)... ... September 19, 2017 , ... Only a few physicians were ... Brevard’s own Ross A. Clevens, MD, FACS . The founder and medical director ... and Reconstructive Surgeon who trained at Yale, Harvard and the University of Michigan. He ...
(Date:9/19/2017)... ... September 19, 2017 , ... ... for the President’s Malaria Initiative (PMI) Africa Indoor Residual Spraying (AIRS) Project ... Award. , The Innovation to Action Award, a USAID Catalyst Award, recognizes ...
(Date:9/19/2017)... ... September 19, 2017 , ... The American College ... to its recently formed Corporate Roundtable, a group of individuals and organizations whose ... world. , Canyon Ranch is a unique collection of lifestyle-based immersion vacation settings ...
Breaking Medicine News(10 mins):