Click here to close now.




















Welcome!

Agile Computing Authors: Gregor Petri, Georgiana Comsa, Elizabeth White, Samuel Scott, 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
The Internet of Things is in the early stages of mainstream deployment but it promises to unlock value and rapidly transform how organizations manage, operationalize, and monetize their assets. IoT is a complex structure of hardware, sensors, applications, analytics and devices that need to be able to communicate geographically and across all functions. Once the data is collected from numerous endpoints, the challenge then becomes converting it into actionable insight.
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and analyzed? As an area of investment, how might a retail company move towards an innovation methodolo...
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Treloar, President and COO of Bebaio, will explore examples of brands transforming their businesses by t...
Through WebRTC, audio and video communications are being embedded more easily than ever into applications, helping carriers, enterprises and independent software vendors deliver greater functionality to their end users. With today’s business world increasingly focused on outcomes, users’ growing calls for ease of use, and businesses craving smarter, tighter integration, what’s the next step in delivering a richer, more immersive experience? That richer, more fully integrated experience comes about through a Communications Platform as a Service which allows for messaging, screen sharing, video...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevOps to advance innovation and increase agility. Specializing in designing, imple...
As more and more data is generated from a variety of connected devices, the need to get insights from this data and predict future behavior and trends is increasingly essential for businesses. Real-time stream processing is needed in a variety of different industries such as Manufacturing, Oil and Gas, Automobile, Finance, Online Retail, Smart Grids, and Healthcare. Azure Stream Analytics is a fully managed distributed stream computation service that provides low latency, scalable processing of streaming data in the cloud with an enterprise grade SLA. It features built-in integration with Azur...
SYS-CON Events announced today that Micron Technology, Inc., a global leader in advanced semiconductor systems, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Micron’s broad portfolio of high-performance memory technologies – including DRAM, NAND and NOR Flash – is the basis for solid state drives, modules, multichip packages and other system solutions. Backed by more than 35 years of technology leadership, Micron's memory solutions enable the world's most innovative computing, consumer,...
Contrary to mainstream media attention, the multiple possibilities of how consumer IoT will transform our everyday lives aren’t the only angle of this headline-gaining trend. There’s a huge opportunity for “industrial IoT” and “Smart Cities” to impact the world in the same capacity – especially during critical situations. For example, a community water dam that needs to release water can leverage embedded critical communications logic to alert the appropriate individuals, on the right device, as soon as they are needed to take action.
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts, GM of Platform at FinancialForce.com, will discuss the value of business applications on wearable ...
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
While many app developers are comfortable building apps for the smartphone, there is a whole new world out there. In his session at @ThingsExpo, Narayan Sainaney, Co-founder and CTO of Mojio, will discuss how the business case for connected car apps is growing and, with open platform companies having already done the heavy lifting, there really is no barrier to entry.
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
The Internet of Things (IoT) is about the digitization of physical assets including sensors, devices, machines, gateways, and the network. It creates possibilities for significant value creation and new revenue generating business models via data democratization and ubiquitous analytics across IoT networks. The explosion of data in all forms in IoT requires a more robust and broader lens in order to enable smarter timely actions and better outcomes. Business operations become the key driver of IoT applications and projects. Business operations, IT, and data scientists need advanced analytics t...
In his session at @ThingsExpo, Lee Williams, a producer of the first smartphones and tablets, will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ETwater. He will explain how M2M controllers work through wirelessly connected remote controls; and specifically delve into a retrofit option that reverse-engineers control codes of existing conventional controller systems so they don't have to be replaced and are instantly converted to become smart, connected devices.
SYS-CON Events announced today that IceWarp will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
Akana has announced the availability of the new Akana Healthcare Solution. The API-driven solution helps healthcare organizations accelerate their transition to being secure, digitally interoperable businesses. It leverages the Health Level Seven International Fast Healthcare Interoperability Resources (HL7 FHIR) standard to enable broader business use of medical data. Akana developed the Healthcare Solution in response to healthcare businesses that want to increase electronic, multi-device access to health records while reducing operating costs and complying with government regulations.
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducted a live demonstration of how quickly application development can happen when the need to comply wit...
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.