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:2/11/2016)... -- Walgreens has committed to provide drug disposal kiosks ... D.C. as part of a program to combat ... advocacy organization As You Sow. Conrad MacKerron , ... on to unneeded drugs because they lack easily accessible collection ... --> Conrad MacKerron , Senior Vice President at As ...
(Date:2/11/2016)... Ga. , Feb. 11, 2016  MiMedx Group, ... company utilizing human amniotic membrane and other birth tissues, ... platforms to develop and market advanced products and therapies, ... Capital Markets, 2016 Global Healthcare Conference in ... Chairman and CEO, Michael J. Senken , Chief ...
(Date:2/11/2016)... de 2016  A Proliant Biologicals anuncia, com ... bovina (BSA -- Bovine Serum Albumin ) ... Norte da Nova Zelândia, em Feilding. ... da Proliant nos EUA, localizada em ... dos equipamentos foram feitos de forma a reproduzir ...
Breaking Medicine Technology:
(Date:2/11/2016)... , ... February 11, 2016 , ... Florida Hospital presents ... take on the St. Louis Blues at the Amalie Arena. The puck drops at ... walk-through heart exhibit, the MEGA Heart, prior to the game. The MEGA Heart will ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... reverse diabetes has been gearing up for their simultaneous grand openings in March. ... about right now that you’re probably wondering, is reversing diabetes possible? According to ...
(Date:2/11/2016)... ... February 11, 2016 , ... veEDIS Clinical Systems, LLC, ... highly adaptable algorithms, has been updated to help Emergency Department physicians and nurses ... with Zikas and a travel history to affected regions, or potential exposure through ...
(Date:2/11/2016)... FL (PRWEB) , ... February 11, 2016 , ... ... the commencement of a master charity program created to assist the people of ... days, working closely with nonprofit organizations and community leaders. Their hope is to ...
(Date:2/11/2016)... ... ... Dickinson Insurance & Financial Services continues their commitment to act as Agents ... local boy named Barrett, who has been fighting ALL leukemia for almost two years. ... all local families dealing with childhood cancer. Information on how to help is now ...
Breaking Medicine News(10 mins):