Navigation Links
Roche Submits Acute Hepatitis B Test to FDA for Premarket Approval
Date:7/26/2011

INDIANAPOLIS, July 26, 2011 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for the Elecsys Anti-HBc IgM assay for use on the cobas e 411, cobas e 601 and MODULAR ANALYTICS E170 analyzers. The hepatitis B test represents the final component of the acute panel within the hepatitis menu on Roche's family of immunoassay analyzers.

The PMA submission is for use of the assay in 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 acute or recent hepatitis B virus (HBV) infection.* The assay is intended to be used with Roche's electrochemiluminescence (ECL) immunoassay technology.

Roche currently has seven other immunoassay tests available on its hepatitis menu:  HBsAg, HBsAg Confirmatory, Anti-HBs, Anti-HCV, Anti-HAV, Anti-HAV IgM and Anti-HBc.

The FDA has 45 days after the PMA is received to notify Roche whether the application has been filed. If the PMA is accepted for filing, the FDA has a 180-day period for substantive review of the application.

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 biology technology :

1. China Agri-Business Acquired Management and Operation Rights of Shaanxi Qinfeng Agrochemical Inc. in Xian, China
2. Proceedings of the National Academy of Sciences (PNAS) Publishes Roche Manuscript on Production of Bispecific IgG Antibodies
3. Roche Building Awarded LEED® Gold Certification
4. Rules-Based Medicine Reaches a Significant Milestone in Companion Diagnostic Program With Roche
5. Designed by Kids, Built by Volunteers: Roche, New Jersey Community Development Corporation, and KaBOOM! Build New Playground in Just One Day for Paterson Public School Children
6. Roche Diabetes Care in the U.S. Turns to Social Media to Promote Diabetes Education, Awareness and Advocacy
7. Pivotal Study Validates Roches cobas® HPV Test with HPV-16 and 18 Genotyping for Identifying Women at Highest Risk for Cervical Cancer
8. Halozyme Announces Roche Doses First Patient in Phase 3 Clinical Trial With Subcutaneous MabThera® (rituximab)
9. Roche, Baylor Research Institute Partner in Human Immunology Research
10. Roche Diabetes Care Forms Human Blue Circle, Supports Viral Video for World Diabetes Day
11. Heiner Dreismann, Ph.D., Former President of Roche Molecular Systems, Joins the HistoRx Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  Regular discussions on a ... take place between the two entities said Poloz. ... Ottawa , he pointed to the country,s ... the federal government. ... said, "Both institutions have common economic goals, why not sit ...
(Date:6/24/2016)... ... June 24, 2016 , ... Researchers at the Universita Politecnica delle Marche in ... peritoneal or pleural mesothelioma. Their findings are the subject of a new article on ... biomarkers are signposts in the blood, lung fluid or tissue of mesothelioma patients that ...
(Date:6/23/2016)... 23, 2016   Boston Biomedical , an ... designed to target cancer stemness pathways, announced that ... Orphan Drug Designation from the U.S. Food and ... cancer, including gastroesophageal junction (GEJ) cancer. Napabucasin is ... inhibit cancer stemness pathways by targeting STAT3, and ...
(Date:6/23/2016)... 2016 Houston Methodist Willowbrook Hospital has ... Association to serve as their official health care ... Willowbrook will provide sponsorship support, athletic training services, ... coaches, volunteers, athletes and families. "We ... Association and to bring Houston Methodist quality services ...
Breaking Biology Technology:
(Date:6/22/2016)... , June 22, 2016   ... management and verification solutions, has partnered with ... software solutions for Visitor Management, Self-Service Kiosks ... provides products that add functional enhancements to ... provides corporations and venues with an automated ...
(Date:6/15/2016)... 15, 2016 Transparency Market ... Recognition Market by Application Market - Global Industry Analysis Size ... to the report, the  global gesture recognition market ... and is estimated to grow at a CAGR ... 2024.  Increasing application of gesture recognition ...
(Date:6/2/2016)... 2016 The Department of Transport Management ... 44 million US Dollar project, for the , ... Personalization, Enrolment, and IT Infrastructure , to ... and implementation of Identity Management Solutions. Numerous renowned international vendors ... Decatur was selected for the most compliant and ...
Breaking Biology News(10 mins):