Click here to close now.

SYS-CON MEDIA Authors: VictorOps Blog, Tim Hinds, Mike Kavis, Plutora Blog, Andreas Grabner

News Feed Item

Roche launches the cobas® Cdiff Test for detection of Clostridium difficile in markets accepting the CE Mark

-- New test expands menu for hospital-acquired infections testing on the cobas® 4800 System

PLEASANTON, California, March 19, 2014 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE-IVD launch of the cobas® Cdiff Test for the detection of Clostridium difficile (C. difficile ) in stool specimens. The cobas® Cdiff Test directly targets the toxin B gene found in toxigenic C. difficile strains in specimens from symptomatic patients and provides accurate information to assist clinicians in making timely treatment decisions and prevention of further infection in healthcare settings.

The cobas® Cdiff Test combines high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps, to facilitate earlier intervention of patients suffering from C. difficile-associated disease. Earlier intervention can also lead to more effective implementation of infection control interventions, which can prevent further transmission to additional patients.

"PCR methods for the detection of toxigenic strains of C. difficile have demonstrated sensitive performance," said Dr. Frederic Barbut, Head of the National Reference Laboratory for Clostridium difficile, Hospital Saint-Antoine, France. "Broad strain coverage and excellent analytical performance can have a positive impact on identifying C. difficile-associated diarrhea, leading to improved patient management."

"With the addition of the cobas® Cdiff Test to our cobas® 4800 menu, Roche offers clinicians an additional tool to aid in the management of hospital-acquired infections," said Paul Brown, head of Roche Molecular Diagnostics. "When compared to other molecular methods, the cobas® Cdiff Test requires less sample handling and provides laboratories with a simplified workflow. It also delivers a lower inhibition rate, which means fewer repeat samples and chances for error, enabling better patient care."

The test is performed on the cobas® 4800 System, currently the only CE-IVD marked system that offers the flexibility to evaluate clinical specimens for the causative agents of sexually transmitted infections (cobas® HSV 1 and 2 Test, cobas® CT/NG Test) and hospital-acquired infections (cobas® Cdiff Test, cobas® MRSA/SA Test), in the same run, on a single platform.

About C. difficile
C. difficile is an anaerobic, toxin producing microorganism known to cause severe diarrhea, pseudomembranous colitis or toxic megacolon, often in patients where normal bacterial flora of the gut has been decimated following antibiotic therapy. Traditional methods for identification include toxigenic culture, which is labor intensive and slow, and enzyme immunoassays (EIA), which have limited sensitivity[1]. Algorithms have been developed using combinations of culture and EIA testing for C. difficile toxins and/or a C. difficile-specific enzyme, glutamate dehydrogenase antigen (GDH), to improve the sensitivity of individual assays alone. Nucleic acid amplification tests provide sensitive and timely identification of patients with C. difficile infection, and exhibit better performance than EIAs[2].

About the cobas® 4800 System
The cobas® 4800 System offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas® MRSA/SA Test, cobas® HSV 1 and 2 Test, cobas® CT/NG Test (chlamydia/gonorrhea), cobas® HPV Test, cobas® BRAF V600 Mutation Test, cobas® EGFR Mutation Test, and the cobas® KRAS Mutation Test.

About Roche
Headquartered 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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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



References:

[1].

Cohen SH, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol 2010; 31:431–55.

[2].

Carroll KC. Tests for the diagnosis of Clostridium difficile infection: the next generation Anaerobe. 2011 Aug;17(4):170-4.

 

For media inquiries please contact:


Bob Purcell, Roche Molecular Diagnostics

888-545-2443


Claudia Panozzo, Austria

+43 1 277 87 360


Bianca Hermle, Germany

+49 621 759 5156


Silvia Zucca, Italy

+39 039 2817 612


Hazel Clarke, UK

+44 1444 256922


Francisco Aguilar-Alvarez, Spain

+34 93583 4011


Eudes de Villiers, France

+33 4 76 76 31 26


Banu Kutlu, Turkey

00902123060606


Harald Borrmann, Switzerland

+41 41 799 6253

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Thanks to Docker, it becomes very easy to leverage containers to build, ship, and run any Linux application on any kind of infrastructure. Docker is particularly helpful for microservice architectures because their successful implementation relies on a fast, efficient deployment mechanism – which is precisely one of the features of Docker. Microservice architectures are therefore becoming more popular, and are increasingly seen as an interesting option even for smaller projects, instead of bein...
Security can create serious friction for DevOps processes. We've come up with an approach to alleviate the friction and provide security value to DevOps teams. In her session at DevOps Summit, Shannon Lietz, Senior Manager of DevSecOps at Intuit, will discuss how DevSecOps got started and how it has evolved. Shannon Lietz has over two decades of experience pursuing next generation security solutions. She is currently the DevSecOps Leader for Intuit where she is responsible for setting and driv...
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @Things...
SYS-CON Events announced today that Open Data Centers (ODC), a carrier-neutral colocation provider, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Open Data Centers is a carrier-neutral data center operator in New Jersey and New York City offering alternative connectivity options for carriers, service providers and enterprise customers.
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along...
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @Things...
PubNub on Monday has announced that it is partnering with IBM to bring its sophisticated real-time data streaming and messaging capabilities to Bluemix, IBM’s cloud development platform. “Today’s app and connected devices require an always-on connection, but building a secure, scalable solution from the ground up is time consuming, resource intensive, and error-prone,” said Todd Greene, CEO of PubNub. “PubNub enables web, mobile and IoT developers building apps on IBM Bluemix to quickly add sc...
Data-intensive companies that strive to gain insights from data using Big Data analytics tools can gain tremendous competitive advantage by deploying data-centric storage. Organizations generate large volumes of data, the vast majority of which is unstructured. As the volume and velocity of this unstructured data increases, the costs, risks and usability challenges associated with managing the unstructured data (regardless of file type, size or device) increases simultaneously, including end-to-...
Sensor-enabled things are becoming more commonplace, precursors to a larger and more complex framework that most consider the ultimate promise of the IoT: things connecting, interacting, sharing, storing, and over time perhaps learning and predicting based on habits, behaviors, location, preferences, purchases and more. In his session at @ThingsExpo, Tom Wesselman, Director of Communications Ecosystem Architecture at Plantronics, will examine the still nascent IoT as it is coalescing, includin...
The cloud has transformed how we think about software quality. Instead of preventing failures, we must focus on automatic recovery from failure. In other words, resilience trumps traditional quality measures. Continuous delivery models further squeeze traditional notions of quality. Remember the venerable project management Iron Triangle? Among time, scope, and cost, you can only fix two or quality will suffer. Only in today's DevOps world, continuous testing, integration, and deployment upend...
The excitement around the possibilities enabled by Big Data is being tempered by the daunting task of feeding the analytics engines with high quality data on a continuous basis. As the once distinct fields of data integration and data management increasingly converge, cloud-based data solutions providers have emerged that can buffer your organization from the complexities of this continuous data cleansing and management so that you’re free to focus on the end goal: actionable insight.
In the consumer IoT, everything is new, and the IT world of bits and bytes holds sway. But industrial and commercial realms encompass operational technology (OT) that has been around for 25 or 50 years. This grittier, pre-IP, more hands-on world has much to gain from Industrial IoT (IIoT) applications and principles. But adding sensors and wireless connectivity won’t work in environments that demand unwavering reliability and performance. In his session at @ThingsExpo, Ron Sege, CEO of Echelon...
With several hundred implementations of IoT-enabled solutions in the past 12 months alone, this session will focus on experience over the art of the possible. Many can only imagine the most advanced telematics platform ever deployed, supporting millions of customers, producing tens of thousands events or GBs per trip, and hundreds of TBs per month. With the ability to support a billion sensor events per second, over 30PB of warm data for analytics, and hundreds of PBs for an data analytics arc...
Between the compelling mockups and specs produced by your analysts and designers, and the resulting application built by your developers, there is a gulf where projects fail, costs spiral out of control, and applications fall short of requirements. In his session at DevOps Summit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, will present a new approach where business and development users collaborate – each using tools appropriate to their goals and expertise – to build mo...