Navigation Links
Roche Submits Application for Clearance of Chlamydia and Gonorrhoeae Test
Date:5/6/2011

PLEASANTON, Calif., May 6, 2011 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has filed for FDA clearance of its Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) tests.

When cleared this standardized and fully automated test will help physicians detect and subsequently treat patients with the disease. Clinical trial data will be presented at the 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID, May 7-13, Milan, Italy) demonstrating the effectiveness of the assay using multiple sample types. The test is suitable for use in a broad range of settings and laboratories. Roche was the first company to offer a Polymerase Chain Reaction (PCR) based CT/NG test. This latest offering builds on that legacy while introducing novel features that meet customer needs.

"We are pleased to submit for review this innovative test that will address a key medical need," said Paul Brown, Ph.D., Head of Roche Molecular Diagnostics. "With this test Roche will expand the menu on the recently approved cobas 4800 platform currently in use in the US for HPV testing and so continue to improve the workflow for laboratories."

About ChlamydiaChlamydia is the most common bacterial Sexually Transmitted Disease (STD) with the highest prevalence among youth. Routine screening for chlamydial infection in young women has been demonstrated to reduce infection rates and the long-term consequences of untreated disease, as well as lowering the cost of this STD to society.  The Center for Disease Control recommends annual Chlamydia trachomatis screening for all sexually active females under 25 years old and additional testing for pregnant women and those with risk factors.

About cobas 4800 CT/NG testThe test runs on the fully automated cobas 4800 platform which was recently introduced in the US concurrent with the approval of Roche's HPV test.

The cobas CT/NG  test is a qualitative in-vitro test for the detection of CT/NG in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of CT/NG in a single analysis. The test, CE marked in 2009, is currently available in numerous countries around the world.

The cobas 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information.  

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.

All trademarks used or mentioned in this release are protected by law.Roche Molecular SystemsPhone: 888-545-2443
'/>"/>

SOURCE Roche
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Rochester Medical Reports Second Quarter Results
2. Rochester Medical Announces Second Quarter 2011 Earnings Conference Call Thursday, May 5, 2011
3. Roche Launches EMR Interface for VA to Facilitate Diabetes Management
4. Rochester Medical Completes Acquisition of Laprolan
5. MITs Koch Institute to use Roche LightCycler 480 System to Help Advance Cancer Research
6. Fornix Shareholders Approve the Sale of Laprolan B.V. to Rochester Medical Corporation
7. Janet Hammond Joins Roche as Vice President, Translational Medicine - Virology
8. Cellular Dynamics International and Roche Transition Early Access Collaboration into a Standard Supply Agreement Ahead of Schedule
9. Roche Teams with Womack Army Medical Center to Become First IVD Manufacturer approved for Remote Network Connectivity with DOD
10. Rochester Medical Reports First Quarter Results and Recent Developments
11. Rochester Medical Announces First Quarter 2011 Earnings Conference Call Tuesday, January 25, 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2017)... Period October – December 2016 ... to SEK -16.4 (-6.4) million Result after tax amounted to ... after dilution Cash flow from operating activities amounted to SEK ... Period full ... Operating result amounted to SEK -39.5 (-29.5) million ...
(Date:2/24/2017)... Mass. , Feb. 24, 2017  Today, ... US dental labs have a new path to ... using the Biodenta implant library integrated into exocad ... must implement FDA compliant Good Manufacturing Processes (GMP,s) ... manufacturer with Biodenta, and complete an audit process. Then, ...
(Date:2/24/2017)... Research and Markets has announced the addition ... Industry Forecast to 2025" report to their offering. ... The Global Wireless Health ... over the next decade to reach approximately $330.5 billion by 2025. ... for all the given segments on global as well as regional ...
Breaking Medicine Technology:
(Date:2/26/2017)... ... February 26, 2017 , ... NuevaCare, a leading home care agency based ... and Palo Alto, is proud to announce an important upgrade to its geographic information ... home care close to home, and by having city-specific pages, NuevaCare is answering that ...
(Date:2/26/2017)... ... February 26, 2017 , ... ... staffing, scheduling, and reporting for healthcare organizations. This comprehensive and customizable solution ... staffing process. StaffBridge technology improves staffing efficiency, maximizes resource allocation, collects critical ...
(Date:2/26/2017)... ... February 26, 2017 , ... Occupational pesticide exposure is ... specific LRRK2 mutation, according to a study released today at the 1st Pan ... a link between pesticides and incidence of sporadic PD through occupational exposure. This ...
(Date:2/24/2017)... ... February 24, 2017 , ... ... tooth replacement options at his office, Antoine Dental Center. Currently, patients can get ... Some restrictions may apply, but patients can learn more about these offers by ...
(Date:2/24/2017)... ... 24, 2017 , ... An in-depth computational analysis of genetic variants implicated in ... eight genes that may explain why susceptibility to one of the disorders could place ... published today in the journal npj Schizophrenia. , “There is a wealth of ...
Breaking Medicine News(10 mins):