Welcome!

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
Both SaaS vendors and SaaS buyers are going “all-in” to hyperscale IaaS platforms such as AWS, which is disrupting the SaaS value proposition. Why should the enterprise SaaS consumer pay for the SaaS service if their data is resident in adjacent AWS S3 buckets? If both SaaS sellers and buyers are using the same cloud tools, automation and pay-per-transaction model offered by IaaS platforms, then why not host the “shrink-wrapped” software in the customers’ cloud? Further, serverless computing, cl...
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem" ...
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, explained the best practices of continuous testing at high scale, which is rele...
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Hardware virtualization and cloud computing allowed us to increase resource utilization and increase our flexibility to respond to business demand. Docker Containers are the next quantum leap - Are they?! Databases always represented an additional set of challenges unique to running workloads requiring a maximum of I/O, network, CPU resources combined with data locality.
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"A lot of times people will come to us and have a very diverse set of requirements or very customized need and we'll help them to implement it in a fashion that you can't just buy off of the shelf," explained Nick Rose, CTO of Enzu, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and micro services. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your contain...
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
"We host and fully manage cloud data services, whether we store, the data, move the data, or run analytics on the data," stated Kamal Shannak, Senior Development Manager, Cloud Data Services, IBM, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Who are you? How do you introduce yourself? Do you use a name, or do you greet a friend by the last four digits of his social security number? Assuming you don’t, why are we content to associate our identity with 10 random digits assigned by our phone company? Identity is an issue that affects everyone, but as individuals we don’t spend a lot of time thinking about it. In his session at @ThingsExpo, Ben Klang, Founder & President of Mojo Lingo, discussed the impact of technology on identity. Sho...
Information technology (IT) advances are transforming the way we innovate in business, thereby disrupting the old guard and their predictable status-quo. It’s creating global market turbulence. Industries are converging, and new opportunities and threats are emerging, like never before. So, how are savvy chief information officers (CIOs) leading this transition? Back in 2015, the IBM Institute for Business Value conducted a market study that included the findings from over 1,800 CIO interviews ...