Welcome!

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.

Latest Stories
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Deploying applications in hybrid cloud environments is hard work. Your team spends most of the time maintaining your infrastructure, configuring dev/test and production environments, and deploying applications across environments – which can be both time consuming and error prone. But what if you could automate provisioning and deployment to deliver error free environments faster? What could you do with your free time?
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...