Welcome!

Agile Computing Authors: Elizabeth White, Yeshim Deniz, Carmen Gonzalez, Liz McMillan, Janakiram MSV

News Feed Item

QIAGEN Gains SFDA Approval to Market careHPV Test in China - Expanding Access to HPV Testing in Low-resource Countries

SHENZEN, China and HILDEN, Germany, November 28, 2012 /PRNewswire/ --

  • Commercial launch of careHPV in China and other emerging markets will enable high-quality screening for prevention of cervical cancer
  • "Country of Origin" approval key for dissemination, other countries are able to use this as a basis for registration
  • careHPV is the first HPV test designed for areas with limited healthcare infrastructure, complementing QIAGEN's market-leading digene  HC2 HPV Test

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that China's State Food and Drug Administration (SFDA) has approved QIAGEN's careHPV Test and instrument platform. The careHPV Test is the first molecular diagnostic to screen for high risk human papillomavirus (HPV) designed for low-resource clinical settings, such as areas lacking electricity, water or modern laboratory infrastructure. QIAGEN expects to announce the product availability of careHPV in China in January 2013, followed by India later in 2013 and other emerging markets as approvals are received. QIAGEN will introduce the careHPV Test and key data of its performance at the International Papillomavirus (IPV) conference, starting November 30 in Puerto Rico.

QIAGEN is the global market leader in HPV testing with its  "gold standard" digene HC2 HPV Test,  the most validated and sensitive diagnostic for detection of high-risk HPV - a primary cause of cervical cancer. It is the only assay that has demonstrated its effectiveness in close to 1 million women in clinical, randomized and independent studies. The digene HC2 test, compatible with modern laboratories and automated processing, is widely used in developed countries and large cities in emerging markets, including China. The digene HC2 test has protected more than 100 million women so far and remains QIAGEN's core product for cervical cancer prevention. The careHPV and digene HC2 tests are both based on clinically proven Hybrid Capture technology, and are highly complementary because they serve different laboratory needs.

QIAGEN developed the careHPV Test in collaboration with PATH, an international nonprofit organization, to expand access to HPV screening in low-resource settings. The robust, portable, and easy-to-use careHPV assay, instrument and collection devices are designed for areas with limited infrastructure and can provide results during the patient visit. Many regions with the highest burdens of cervical cancer lack electricity, water or modern laboratory infrastructure. To address the needs in such regions, QIAGEN's careHPV Test includes many innovative design and technology features. For example, the system has color coded, easy to understand menus, contained reagents, and tolerates temperature variations that occur in rural clinics lacking refrigeration for sample storage due to limited electricity or water. Non-medical staff can be trained in hours to use the careHPV system, and the test also has been shown to avoid cross-contamination of samples even in the most stringent settings.

"As the only test of its kind, careHPV offers the life-saving benefits of sensitive molecular diagnostics to resource-poor regions. About 275,000 women a year die from cervical cancer, more than 85 percent in less-developed countries. We have teamed with PATH to create careHPV as part of a preventive strategy that will save many women's lives," said Dr. Helge Lubenow, Senior Vice President, Molecular Diagnostics Business Area. "We are expanding QIAGEN's Prevention portfolio by launching the careHPV system in emerging markets, both through a commercial offering to healthcare providers and through donations to governments and NGOs that are in the process of implementing large scale cervical cancer prevention plans. This new product complements our well-established global leadership with the digene HC2 HPV test and can also be used very synergistically for example to allow national or regional screening programs to cover the infrastructure profiles of all segments within the targeted region."

The careHPV Test is manufactured by QIAGEN in Shenzhen, China, making the "country of origin" approval a critical milestone. Many countries are able to use this approval by the SFDA for their own regulatory approval, instead of conducting lengthy and costly local regulatory submissions. The careHPV rollout will target areas in Asia, Latin America, Eastern Europe and Africa.

Clinical studies with the careHPV Test have been conducted in China, Nigeria, Rwanda and Thailand in parallel with PATH demonstration trials in China, India, Uganda and Nicaragua. The data demonstrate the high sensitivity and reliability of the careHPV Test in low-resource settings.

The careHPV Test already plays a central role in QIAGENcares, the company's collaboration with NGOs and governments to expand access to high-quality cervical cancer screening in resource-poor regions. QIAGEN is committed to donating 1.5 million HPV tests to improve life in the world's poorest nations. For example, QIAGEN has partnered with vaccine manufacturer Merck & Co., Inc., to design and implement comprehensive public programs to fight cervical cancer in poor countries, starting in Rwanda. The programs have taken many forms: QIAGENcares has helped clinicians in Brazil install the careHPV device on mobile units to conduct cervical cancer screening in remote areas. El Salvador's government, working with the nonprofit group Basic Health International, is evaluating the integration of careHPV into a national screening program together with screening solutions based on the digene HC2 test which would be used in cities. Projects in South Africa and Burkina Faso have also used careHPV. To learn more about QIAGENcares please visit: http://www.qiagen.com/about/whoweare/qiagencares/qiagencares.aspx.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research). As of September 30, 2012, QIAGEN employed approximately 4,000 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results, including without limitation its expected operating results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products in  applied testing, personalized healthcare, clinical research,  proteomics, women's health/HPV testing and  nucleic acid-based  molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products, the consummation of acquisitions, and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

Contacts:

Public Relations:
Dr. Thomas Theuringer
Director Public Relations
+49-2103-29-11826
+1-240-686-7425

Email: [email protected]

http://www.twitter.com/qiagen
http://www.qiagen.com/about/press

Investor Relations:
John Gilardi
VP Corporate Communications
+49-2103-29-11711
+1-240-686-2222

Email: [email protected]
http://www.qiagen.com/about/investorrelation


SOURCE Qiagen N.V.

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
@ThingsExpo has been named the Most Influential ‘Smart Cities - IIoT' Account and @BigDataExpo has been named fourteenth by Right Relevance (RR), which provides curated information and intelligence on approximately 50,000 topics. In addition, Right Relevance provides an Insights offering that combines the above Topics and Influencers information with real time conversations to provide actionable intelligence with visualizations to enable decision making. The Insights service is applicable to eve...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, 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 opportunity. Submit your speaking proposal ...
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, 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.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software in the hope of capturing value in IoT. Although IoT is relatively new in the market, it has already gone through many promotional terms such as IoE, IoX, SDX, Edge/Fog, Mist Compute, etc. Ultimately, irrespective of the name, it is about deriving value from independent software assets participating in an ecosystem as one comprehensive solution.
SYS-CON Events announced today that Hitachi Data Systems, a wholly owned subsidiary of Hitachi LTD., will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City. Hitachi Data Systems (HDS) will be featuring the Hitachi Content Platform (HCP) portfolio. This is the industry’s only offering that allows organizations to bring together object storage, file sync and share, cloud storage gateways, and sophisticated search an...
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...