Welcome!

Agile Computing Authors: Harry Trott, Carmen Gonzalez, AppNeta Blog, Elizabeth White, Pat Romanski

News Feed Item

QIAGEN Seeks U.S. Regulatory Clearance for Full QIAsymphony RGQ MDx Workflow and Announces Submission of First Assay of its HAI Portfolio

GERMANTOWN, Maryland, and HILDEN, Germany, January 29, 2014 /PRNewswire/ --

  • Diagnostic workflow for C. difficile  is launched in Europe and submitted in the U.S. for 510(k) clearance as the first of several new kits in QIAGEN's pipeline for healthcare-associated infections (HAI)
  • QIAGEN submits automation system QIAsymphony RGQ MDx to FDA for regulatory clearance, reiterates goals of 1,250 cumulative placements by year-end 2014 and 1,500 by end of 2015

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced plans to roll out a portfolio of assays for the QIAsymphony platform to aid in the diagnosis of healthcare-associated infections. The first new test the artus C. difficile QS-RGQ MDx Kit has been submitted to the U.S. Food and Drug Administration (FDA). QIAGEN already launched a C. difficile test in Europe after receiving CE-marking in December.

Along with the C. difficile test, QIAGEN also submitted the automation platform QIAsymphony RGQ MDx to the FDA. QIAsymphony is a modular system that covers entire laboratory workflows from sample to results. It is composed of QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and QIAGEN's real-time PCR detection platform Rotor-Gene Q MDx, which received FDA clearance in 2012. While the QIAsymphony platform has the broadest menu in its category in Europe and other markets, the system is currently primarily used for laboratory developed assays in the United States.

"QIAGEN's highly reliable diagnostics running on the QIAsymphony platform allow customers to experience excellent assay performance, quicker results to benefit patients, and improved laboratory efficiency. The expanding content menu adds value to QIAsymphony, which has become the system of choice in medium-throughput molecular testing," said Peer M. Schatz, Chief Executive Officer.

"The U.S. submission of the QIAsymphony RGQ MDx system is a pivotal step in expanding global adoption of the QIAsymphony platform to revolutionize laboratory workflows. As novel new content continues to emerge from our pipeline, users will be able to consolidate the broadest range of molecular tests available on a single instrument platform," Mr. Schatz said. "The QIAsymphony platform is positioned for long term, strong growth for QIAGEN. In 2013 we exceeded our target of 1,000 placements and we now target more than 1,250 placements by the end of 2014 and 1,500 by the end of 2015. The strong increase in placements coupled with the expanding menu creates an exciting future for this franchise."

Healthcare-associated infections - addressing an urgent need

Healthcare-associated infections (also called HAIs) affect an estimated 5.8 million hospitalized patients a year in Europe and the United States, leading to more than 100,000 deaths, according to the World Health Organization. These pathogens also impose an economic burden with direct costs estimated at 7 billion euros in Europe and $6.5 billion in the U.S. due to extra days of hospitalization, according to the World Health Organization. Figures are less precise in less developed regions of the world, but HAIs pose a global challenge in healthcare.

The C. difficile tests launched in Europe and under review in the U.S. will aid in the diagnosis of Clostridium difficile infection, the most prevalent HAI in the United States. C. difficile often infects patients in hospitals or nursing facilities, causing symptoms ranging from diarrhea to life-threatening inflammation of the colon. QIAGEN's ready-to-use molecular assay delivers sensitive and specific detection of both toxin A and toxin B of C. difficile. This assay for the QIAsymphony system was developed in partnership with IntelligentMDx, based in Waltham, Massachusetts, under a multiyear agreement.

QIAGEN aims to market the broadest test portfolio for healthcare associated infections in Europe, North America and rest of the world. The VanR and MRSA/SA tests are in advanced stage of development and will be submitted for clearance this year, followed by further additions to QIAGEN's HAI panel as well as other panels.

QIAsymphony content menu expanding

QIAGEN's portfolio now includes more than 20 CE-marked assays in Europe along with one FDA-cleared and two FDA-approved diagnostic assays in the United States designed to run on the Rotor-Gene Q MDx platform, which is part of the QIAsymphony family. About 35 new tests are currently in development for a variety of biomarkers.

In Personalized Healthcare, the QIAsymphony content menu continues to add companion diagnostics in cancer and other diseases. In January, the CE-marked therascreen IDH1/2 RGQ Kit was launched in Europe, enabling physicians to better diagnose and assess the prognosis of patients with gliomas (tumors of the brain and spinal cord). QIAGEN has partnered with more than 15 leading pharmaceutical and biotechnology companies to co-develop additional companion diagnostics.

In Profiling of infectious diseases, the RespiFinder RG Panel, a multiplex PCR assay for the simultaneous detection and differentiation of 21 respiratory pathogens, also was recently launched in Europe. It is the first highly multiplexed pathogen assay designed to run on the Rotor-Gene Q.

About QIAGEN

QIAGEN N.V., a Netherlands-based 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 December 31, 2013, QIAGEN employed approximately 4,000 people in more than 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
pr.qiagen.com

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

Email: [email protected]
ir.qiagen.com

SOURCE Qiagen

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
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of 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, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, Cloud Expo and @ThingsExpo are two of the most important technology events of the year. Since its launch over eight years ago, Cloud Expo and @ThingsExpo have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors! In this blog post, I provide 7 tips on how, as part of our world-class faculty, you can deliver one of the most popular sessions at our events. But before reading the...
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
In his session at @ThingsExpo, Steve Wilkes, CTO and founder of Striim, will delve into four enterprise-scale, business-critical case studies where streaming analytics serves as the key to enabling real-time data integration and right-time insights in hybrid cloud, IoT, and fog computing environments. As part of this discussion, he will also present a demo based on its partnership with Fujitsu, highlighting their technologies in a healthcare IoT use-case. The demo showcases the tracking of patie...
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.
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
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.
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...
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists peeled 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 enviro...
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business. Though, IoT is far more complex than most firms expected with a majority of IoT projects having failed. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, Chief IoTologist at Wipro, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology portfolios and business models to adopt and leverage IoT. He will delve in...
SYS-CON Events announced today that Outlyer, a monitoring service for DevOps and operations teams, has been named “Bronze Sponsor” of 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. Outlyer is a monitoring service for DevOps and Operations teams running Cloud, SaaS, Microservices and IoT deployments. Designed for today's dynamic environments that need beyond cloud-scale monitoring, we make monitoring effortless so you...
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his Day 2 Keynote at @ThingsExpo, Henrik Kenani Dahlgren, Portfolio Marketing Manager at Ericsson, discussed how to plan to cooperate, partner, and form lasting all-star teams to change the...
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, 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. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
There are 66 million network cameras capturing terabytes of data. How did factories in Japan improve physical security at the facilities and improve employee productivity? Edge Computing reduces possible kilobytes of data collected per second to only a few kilobytes of data transmitted to the public cloud every day. Data is aggregated and analyzed close to sensors so only intelligent results need to be transmitted to the cloud. Non-essential data is recycled to optimize storage.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of 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. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great dea...
“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.
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, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/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.