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 worldwi
'/>"/>

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

Page: 1 2

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:6/3/2015)... 02, 2015 Research and Markets ... of the "2015 Strategies in the ... to their offering. This new ... immunoprotein diagnostic market, including emerging tests, technologies, ... profiles of leading suppliers. During ...
(Date:6/3/2015)... Minn. , June 3, 2015 ... that supports the entire spectrum of clinical research, is ... iMedNet eClinical technology platform will ... by the end of this month.  iMedNet ... – built from the ground up by MedNet Solutions, ...
(Date:6/3/2015)... 2015 Typical racks for laboratory freezers ... and depths often taking up unnecessary room in already ... Low 5 Box Freezer Racks offer a customizable ... freezer storage boxes and freezers. , “These racks ... experiments or multiple people because users can configure freezer ...
(Date:6/3/2015)... 2015 Green Earth Energy has restructured ... support the RCBC Waste to Energy system. Paul ... the family business, http://www.greenearthwaste.com which has been ... added recycling to their waste collection services in 2012 ... the Fortune 500 companies with manufacturing plants in West ...
Breaking Biology Technology:United States Strategies in the Immunoprotein Diagnostic Testing Market Report 2015 2MedNet Announces "2015 Feature 1" Release Of iMedNet eClinical 2Freezer Space Can Now Be Configured Your Way with New Modular Freezer Racks 2
... BioNeutral Group, Inc. ("BioNeutral") (OTC Bulletin Board: BONU), ... that at ATS Labs, using a Quantitative Disk ... (C.diff) spores, BioNeutral,s Ygiene(TM) Hospital Grade antimicrobial delivered ... Clostridium Difficile, an extremely dangerous and difficult to ...
... Novavax, Inc. (Nasdaq: NVAX ) ... their joint venture in India under the agreement signed ... joint venture, called CPL Biologicals Pvt. Ltd., will develop ... using technology contributed from Novavax and Cadila Pharmaceuticals. ...
... safety of their drinking water for granted, that ordinary tap ... of Tel Aviv University,s School of Physics and Astronomy. ... natural disaster or sabotage, the physicist has developed a new ... water supply in real time. Modifying special fibers ...
Cached Biology Technology:BioNeutral's Ygiene(TM) Hospital Grade Antimicrobial Demonstrates a 99.9997% Kill Rate Against Clostridium Difficile Spores (C.diff) in Independent Lab Pre-testing Phase 2BioNeutral's Ygiene(TM) Hospital Grade Antimicrobial Demonstrates a 99.9997% Kill Rate Against Clostridium Difficile Spores (C.diff) in Independent Lab Pre-testing Phase 3Cadila Pharmaceuticals Launches Joint Venture With Novavax in India 2Cadila Pharmaceuticals Launches Joint Venture With Novavax in India 3Cadila Pharmaceuticals Launches Joint Venture With Novavax in India 4Monitoring water through a snake's eyes 2Monitoring water through a snake's eyes 3
(Date:5/29/2015)... May 28, 2015 Research and Markets ... the "Facial Recognition Market by Solution, by ... Forecast to 2020" report to their offering. ... facial recognition technology become more efficient and cost ... traction and investment from the commercial sector. The ...
(Date:5/27/2015)... , May 27, 2015   ... medication safety systems and image documentation solutions ... of comprehensive, technologically-advanced automation solutions, is pleased ... integration. The Codonics® Safe Label System® (SLS), ... in conjunction with the Omnicell Anesthesia Workstation, ...
(Date:5/25/2015)... -- Australia,s market for wearable technologies is considered to be ... of several trials and prototypes. The release of the ... ignite interest in wearables as well as accelerate sales ... This in turn will spur greater innovation from other ... vendors and distributors. Photo - ...
Breaking Biology News(10 mins):Global advanced Facial Recognition Market Expected to Grow From $2.77 Billion in 2015 to $6.19 Billion in 2020, at an Estimated CAGR of 17.4% 2Codonics and Omnicell Expand Partnership 2Codonics and Omnicell Expand Partnership 3Codonics and Omnicell Expand Partnership 4Australian wearables market to grow at CAGR of 78%; revenue of A$1 billion by 2018, says Frost & Sullivan 2Australian wearables market to grow at CAGR of 78%; revenue of A$1 billion by 2018, says Frost & Sullivan 3Australian wearables market to grow at CAGR of 78%; revenue of A$1 billion by 2018, says Frost & Sullivan 4
... reserves such as gold, diamond and natural gas isn,t ... look. Now researchers at Tel Aviv University have modernized the ... signs of lucrative resources that could lurk beneath our feet. ... first time, Prof. Lev Eppelbaum of TAU,s Department of ...
... Bethesda, MDA new research report published in The ... and scientists better understand a rare genetic disease that ... decreased vision called Enhanced S-Cone Syndrome or Goldman-Favre Syndrome. ... genes responsible for the healthy renewal of rods and ...
... had officials along the East Coast preparing for mass ... the University of Delaware were grabbing their best data ... It was a rare opportunity for the scientists ... as Irene threatened to be the biggest hurricane to ...
Cached Biology News:The geophysicist's guide to striking it rich 2Scientists unravel the cause of rare genetic disease: Goldman-Favre Syndrome explained 2Hurricane Irene: Scientists collect water quality and climate change data from huge storm 2
... include: ,ICC and IHC Protocol Development ... ,Antibody Screenings in Animal or Human ... of Cells and Tissues ,Peroxidase, Alkaline ... Fluorescent, or Electron Microscopy ,Protein Localization ...
... the optimization of immunostaining. ... the primary antibody, selection and ... Alk. Phos., HRP, fluorescence, or ... evaluation by light or fluorescence ...
Request Info...
Request Info...
Biology Products: