|By PR Newswire||
|November 27, 2012 01:00 AM EST||
-- 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 PM – 1:45 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.
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:
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
Jul. 26, 2016 06:15 AM EDT Reads: 1,416
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2016 Silicon Valley. The 19th Cloud Expo and 6th @ThingsExpo will take place on November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Interne...
Jul. 26, 2016 05:15 AM EDT Reads: 2,082
Large scale deployments present unique planning challenges, system commissioning hurdles between IT and OT and demand careful system hand-off orchestration. In his session at @ThingsExpo, Jeff Smith, Senior Director and a founding member of Incenergy, will discuss some of the key tactics to ensure delivery success based on his experience of the last two years deploying Industrial IoT systems across four continents.
Jul. 26, 2016 05:00 AM EDT Reads: 1,529
CenturyLink has announced that application server solutions from GENBAND are now available as part of CenturyLink’s Networx contracts. The General Services Administration (GSA)’s Networx program includes the largest telecommunications contract vehicles ever awarded by the federal government. CenturyLink recently secured an extension through spring 2020 of its offerings available to federal government agencies via GSA’s Networx Universal and Enterprise contracts. GENBAND’s EXPERiUS™ Application...
Jul. 26, 2016 03:45 AM EDT Reads: 1,836
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develo...
Jul. 26, 2016 02:00 AM EDT Reads: 1,350
SYS-CON Events announced today that MangoApps 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. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device.
Jul. 26, 2016 01:45 AM EDT Reads: 1,318
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, explained how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
Jul. 26, 2016 01:30 AM EDT Reads: 1,013
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices 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 opportuni...
Jul. 26, 2016 01:15 AM EDT Reads: 2,540
In today's uber-connected, consumer-centric, cloud-enabled, insights-driven, multi-device, global world, the focus of solutions has shifted from the product that is sold to the person who is buying the product or service. Enterprises have rebranded their business around the consumers of their products. The buyer is the person and the focus is not on the offering. The person is connected through multiple devices, wearables, at home, on the road, and in multiple locations, sometimes simultaneously...
Jul. 26, 2016 12:45 AM EDT Reads: 665
“delaPlex Software provides software outsourcing services. We have a hybrid model where we have onshore developers and project managers that we can place anywhere in the U.S. or in Europe,” explained Manish Sachdeva, CEO at delaPlex Software, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 26, 2016 12:00 AM EDT Reads: 1,547
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
Jul. 25, 2016 11:15 PM EDT Reads: 2,022
"We've discovered that after shows 80% if leads that people get, 80% of the conversations end up on the show floor, meaning people forget about it, people forget who they talk to, people forget that there are actual business opportunities to be had here so we try to help out and keep the conversations going," explained Jeff Mesnik, Founder and President of ContentMX, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 25, 2016 11:15 PM EDT Reads: 1,321
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Jul. 25, 2016 10:00 PM EDT Reads: 2,524
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
Jul. 25, 2016 08:30 PM EDT Reads: 1,950
With 15% of enterprises adopting a hybrid IT strategy, you need to set a plan to integrate hybrid cloud throughout your infrastructure. In his session at 18th Cloud Expo, Steven Dreher, Director of Solutions Architecture at Green House Data, discussed how to plan for shifting resource requirements, overcome challenges, and implement hybrid IT alongside your existing data center assets. Highlights included anticipating workload, cost and resource calculations, integrating services on both sides...
Jul. 25, 2016 08:00 PM EDT Reads: 1,994
Big Data engines are powering a lot of service businesses right now. Data is collected from users from wearable technologies, web behaviors, purchase behavior as well as several arbitrary data points we’d never think of. The demand for faster and bigger engines to crunch and serve up the data to services is growing exponentially. You see a LOT of correlation between “Cloud” and “Big Data” but on Big Data and “Hybrid,” where hybrid hosting is the sanest approach to the Big Data Infrastructure pro...
Jul. 25, 2016 07:30 PM EDT Reads: 1,902
"We are a well-established player in the application life cycle management market and we also have a very strong version control product," stated Flint Brenton, CEO of CollabNet,, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 25, 2016 07:15 PM EDT Reads: 1,811
We all know the latest numbers: Gartner, Inc. forecasts that 6.4 billion connected things will be in use worldwide in 2016, up 30 percent from last year, and will reach 20.8 billion by 2020. We're rapidly approaching a data production of 40 zettabytes a day – more than we can every physically store, and exabytes and yottabytes are just around the corner. For many that’s a good sign, as data has been proven to equal money – IF it’s ingested, integrated, and analyzed fast enough. Without real-ti...
Jul. 25, 2016 07:15 PM EDT Reads: 1,035
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Jul. 25, 2016 06:30 PM EDT Reads: 1,046
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
Jul. 25, 2016 06:15 PM EDT Reads: 1,794