Click here to close now.

Welcome!

iPhone Authors: Roger Strukhoff, Mike Kavis, Jayaram Krishnaswamy, Elizabeth White, Kevin Benedict

News Feed Item

Roche Announces Expanded CE Mark Indication for cobas® 4800 HPV Test Supporting Its Use as a Primary Screen for Cervical Cancer

-- HPV DNA detection finds disease missed by Pap cytology

PLEASANTON, California, Nov. 27, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announces an expanded CE mark indication for the cobas® 4800 HPV Test. The newly expanded indication for the cobas® 4800 HPV Test as a primary screen means Pap cytology is no longer required as a co- or pre-test in countries that accept a CE mark.  Persistent infection with Human Papillomavirus is the principal cause of cervical cancer in women.  The expanded indication is supported by data to be presented at the International Papillomavirus Conference, November 30-December 6, 2012 in San Juan, Puerto Rico.

"HPV testing provides a more sensitive level of screening than the Pap test.  Whereas a Pap smear looks for abnormal cells, an HPV test looks for the presence of HPV DNA itself," says Eduardo Franco, director, Division of Cancer Epidemiology, McGill University, Montreal, Canada. "The prevalence of HPV means that many women may test positive, so it is important to also identify those most at risk to progress to cervical cancer. Genotyping for HPV types 16 and 18 provides sufficient additional specificity to identify the women most at risk, and spares the rest from potentially unnecessary intervention.  The two HPV genotypes, 16 and 18, account for 70% of cervical cancer cases."

HPV DNA testing has more traditionally been used as a co-test or reflex test to an abnormal or borderline cytology result.  While Pap screening has dramatically decreased the prevalence of cervical cancer over the past several decades, Pap cytology has limitations due to low sensitivity and the subjective nature of results interpretation.  However, studies show that HPV DNA testing is more sensitive than the Pap smear in picking up disease – important in a front-line screen.  In the landmark ATHENA study,  it is shown that the cobas® 4800 HPV Test finds disease that is missed by cytology - 1 in 10 women who tested positive for either HPV genotypes 16 or 18 by the Roche cobas® 4800 HPV Test already had evidence of cervical pre-cancer, even though their Pap test was normal.

Approximately 275,000 women worldwide still die of cervical cancer each year, and many countries are in the process of piloting HPV DNA testing as a primary screening replacement for Pap cytology.  "Switching towards use of the cobas® 4800 HPV Test as a first line screen enables countries to implement strategies that catch more disease with fewer medical interventions, allows physicians to better manage their patients, and reduces economic costs to the healthcare system," said Paul Brown, Head of Roche Molecular Diagnostics.

The cobas® 4800 HPV Test is the only clinically validated, and FDA-approved test, that simultaneously provides pooled results on known "high-risk" genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18, giving three results in just one test.  The cobas® 4800 HPV Test has a fully automated sample preparation workflow process, and unique efficiency features allowing for higher throughput, making it well suited for high volume screening programs.

"As an organization committed to women's health, Roche Diagnostics is dedicated to keeping women healthy and improving patient care," Paul Brown continued. "Combined with our products from the mtm business acquisition announced last year, Roche has a broad cervical cancer prevention portfolio which redefines cervical cancer screening and more effectively guides patient management decisions." 

International Papillomavirus Conference
Roche will present data which supports the cobas® 4800 HPV Test expanded indication as well as the broader Roche cervical cancer portfolio at the International Papillomavirus Conference, November 30-December 6, 2012 in San Juan, Puerto Rico.

Roche Satellite Symposium:  Translating Science into Primary Screening Practice
Monday, 3 December, 12:30 PM1:45 PM, Puerto Rico Convention Center, Ballroom B

Primary HPV screening: Impact of varying the age of initiation on the performance of screening
Wright TC, Cox JT, Sharma A, Apple R, Behrens CM
Tuesday, 4 December, 2:00PM - 3:30PM, Room 208

3 Year cumulative incidence rates for high-grade cervical disease: Interim analysis from the ATHENA study
Castle PE, Wright TC, Stoler, MH, Zhang, Behrens CM
Tuesday, 4 December, 2:00PM- 3:30PM, Room 208

Intra-laboratory variation in the performance of liquid-based cytology; insights from ATHENA
Stoler MH, Wright TC, Apple R, Sharma A, Behrens CM
Tuesday, 4 December, 5:30PM - 7:30PM (Poster Session)

About the ATHENA Study
Roche's landmark ATHENA study for the cobas® 4800 HPV Test is the largest U.S.-based registration study for cervical cancer screening, including more than 47,000 women. 

About the cobas® 4800 HPV Test and cobas® 4800 System
The cobas® 4800 HPV Test is a qualitative in-vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies the high risk HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68), while simultaneously also detecting the highest risk types, HPV 16 and HPV 18. It is now available in the US and all countries accepting a CE mark.  

The cobas® 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information. The system offers true walk-away automation and can run up to 282 tests in less than 12 hours, providing rapid analysis of screening tests for HPV infections meeting the needs of the majority of clinical labs.

About Human Papillomavirus and Cervical Cancer
Persistent infection with Human Papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. According to the National Cancer Institute, there are 12,200 new cases of cervical cancer in the United States annually and 4,210 deaths due to the disease. The World Health Organization estimates there are 470,000 new cases of cervical cancer annually.

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, 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 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 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 are protected by law.

For media inquiries please contact:
888-545-2443

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.

@ThingsExpo Stories
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada. Our partner network encompasses some 300 of the world's leading systems integrators and security s...
What exactly is a cognitive application? In her session at 16th Cloud Expo, Ashley Hathaway, Product Manager at IBM Watson, will look at the services being offered by the IBM Watson Developer Cloud and what that means for developers and Big Data. She'll explore how IBM Watson and its partnerships will continue to grow and help define what it means to be a cognitive service, as well as take a look at the offerings on Bluemix. She will also check out how Watson and the Alchemy API team up to offer disruptive APIs to developers.
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquired by Aditi Technologies. He is a Microsoft Regional Director for Hyderabad, India, and one of the f...
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal today!
With IoT exploding, massive data will transform businesses with opportunities to monetize almost anything that can be measured. In this C-Level Roundtable Discussion at @ThingsExpo, Brendan O’Brien, Aria Systems Co-founder and Chief Evangelist, will lead an expert panel of consultants, thought leaders and practitioners who will look at these new monetization trends, discuss the implications, and detail lessons learned from their collective experience. Finally, the panel will point the way forward for enterprises who wish to leverage the resulting complex recurring revenue models, adding valu...
SYS-CON Events announced today that Ciqada will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Ciqada™ makes it easy to connect your products to the Internet. By integrating key components - hardware, servers, dashboards, and mobile apps - into an easy-to-use, configurable system, your products can quickly and securely join the internet of things. With remote monitoring, control, and alert messaging capability, you will meet your customers' needs of tomorrow - today! Ciqada. Let your products take flight. For more inform...
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applications - creating more engaging experiences for their customers and boosting collaboration and productiv...
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Company’s core communications platform enables the delivery of a range of enterprise and consumer calling...
VoxImplant has announced full WebRTC support in the newest versions of its Android SDK and iOS SDK. The updated SDKs, which enable audio and video calls on mobile devices, are now compatible with the WebRTC standard to allow any mobile app to communicate with WebRTC-enabled browsers, including Google Chrome, Mozilla Firefox, Opera, and, when available, Microsoft Spartan. The WebRTC-updated SDKs represent VoxImplant's continued leadership in simplifying the development of real-time communications (RTC) services for app developers. VoxImplant (built by Zingaya, the real-time communication servi...
SYS-CON Events announced today that Creative Business Solutions will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Creative Business Solutions is the top stocking authorized HP Renew Distributor in the U.S. Based out of Long Island, NY, Creative Business Solutions offers a one-stop shop for a diverse range of products including Proliant, Blade and Industry Standard Servers, Networking, Server Options and Care Packs. As a trusted supplier, CBS guarantees quality controlled stock levels thanks to an Auto...
SYS-CON Events announced today that AIC, a leading provider of OEM/ODM server and storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. AIC is a leading provider of both standard OTS, off-the-shelf, and OEM/ODM server and storage solutions. With expert in-house design capabilities, validation, manufacturing and production, AIC's broad selection of products are highly flexible and are configurable to any form factor or custom configuration. AIC leads the industry with nearly 20 years of ...
SYS-CON Events announced today that Optimal Design, an Internet of Things solution provider, will exhibit at SYS-CON's Internet of @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Optimal Design is an award winning product development firm offering industrial design and engineering services to the consumer, medical, and defense markets.
SYS-CON Events announced today that Vicom Computer Services, Inc., a provider of technology and service solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. They are located at booth #427. Vicom Computer Services, Inc. is a progressive leader in the technology industry for over 30 years. Headquartered in the NY Metropolitan area. Vicom provides products and services based on today’s requirements around Unified Networks, Cloud Computing strategies, Virtualization around Software defined Data Ce...
How is unified communications transforming the way businesses operate? In his session at WebRTC Summit, Arvind Rangarajan, Director of Product Marketing at BroadSoft, will discuss how to extend unified communications experience outside the enterprise through WebRTC. He will also review use cases across different industry verticals. Arvind Rangarajan is Director, Product Marketing at BroadSoft. He has over 19 years of experience in the telecommunications industry in various roles such as Software Development, Product Management and Product Marketing, applied across Wireless, Unified Communic...
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? Join this panel of experts as they peel away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud environment, and we must architect and code accordingly. At the very least, you’ll have no problem filling in your buzzword bingo cards.
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, will discuss how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at the same time reduce Time to Market (TTM) by using plug and play capabilities offered by a robust I...
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this case) takes into account the number and quality of contextual references that a user receives.
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures traffic gets delivered faster, safer, and more reliably than ever.
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what the future may hold. Mike Kavis is Vice President & Principal Cloud Architect at Cloud Technology Pa...
The only place to be June 9-11 is Cloud Expo & @ThingsExpo 2015 East at the Javits Center in New York City. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT & Big Data companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterprise. Speakers from all over the world will be hand-picked for their ability to explore the economic strategies that utility/cloud computing provides. Whether public, private, or in a hybrid form, clo...