QIAGEN Unveils Sample-to-Result Next-Generation Sequencing Workflow Designed for Clinical Research and Diagnostics

MARCO ISLAND, Florida, and HILDEN, Germany, February 20, 2013 /PRNewswire/ --

• Streamlined and automated NGS workflow will offer many features required to enable routine use in clinical applications
• Building on strengths in Sample & Assay Technologies to create an integrated NGS ecosystem with sample processing, genomic testing and bioinformatics
• New consumable products address critical workflow challenges, expanding QIAGEN's portfolio of "universal" solutions for use on any NGS system

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today provided new insights into its next-generation sequencing (NGS) initiative, unveiling an innovative sample-to-result NGS workflow designed to enable the routine use of this breakthrough technology beyond life sciences research in areas such as clinical research and diagnostics.

QIAGEN's NGS workflow - an ecosystem of products and services to offer automated processes from primary sample to digital result - is being presented to customers this week at the 14th annual Advances in Genome Biology and Technology (AGBT) meeting in Marco Island, Florida.

"Next-generation sequencing is making a transformational impact on life science, but challenges are limiting more widespread adoption for clinical purposes. We are pleased with the progress of our NGS initiative to create a complete portfolio of products and services to make this breakthrough technology more effective, robust and scalable for areas such as clinical research and diagnostics," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "The development of our complete sample-to-result workflow is a key achievement in our initiative to offer a seamless integration of new NGS platforms with high-quality reagents, molecular testing content and services."

"We are leveraging our core expertise with new and existing QIAGEN products to develop the solutions needed for adoption of NGS technologies in new areas beyond basic research," said Dr. Dietrich Hauffe, Senior Vice President, Life Sciences Business Area at QIAGEN. "We are planning to begin placing NGS workflows with selected customer groups during 2013. We expect NGS to complement established molecular technologies, particularly real-time PCR, and to become an important contributor to QIAGEN's leadership in Sample & Assay Technologies."

The adoption of NGS in fields such as clinical research and diagnostics has been hampered for a number of reasons, particularly workflow challenges that become more pronounced in clinical settings due in part to the increased number of samples being processed. Other challenges include manual sample preparation processes, delays caused by batching samples to achieve cost-efficient runs, and the speed and quality of data analysis.

QIAGEN's highly automated NGS workflow addresses these challenges by offering a streamlined and automated workflow built on components that include the following:

• QIAGEN's QIAcube^® for fully automated nucleic acid isolation and purification, as well as library preparation.
• New GeneRead^[TM] DNAseq Target Enrichment gene panels designed for NGS applications based on the GeneGlobe^® collection of more than 60,000 fully annotated molecular assays.
• QIAcube NGS - a new QIAcube-based instrument for automated sequencing template preparation.
• GeneReader^[TM] - a new NGS benchtop sequencer that embraces many diagnostic workflow features and offers a high level of flexibility, scalability and efficiency.
• A dedicated QIAGEN software solution for user-friendly and automated result analysis.

A key element of QIAGEN's NGS workflow is GeneReader, a transformational NGS benchtop sequencer that offers many features essential for customers in clinical research and diagnostics to create routine laboratory processes. Unlike competitors' existing NGS platforms, which process only one flow cell at a time and often require sample pooling for cost-efficient runs, the GeneReader NGS sequencer has a turntable design that enables the continuous loading of up to 20 flow cells for independent and parallel sequencing. Individual patient samples also can be handled cost-efficiently without the need for indexing or bar-coding, which means processing can occur at any time, and in any order, without delay or concerns about potential regulatory issues.

QIAGEN has exclusively licensed sequencing-by-synthesis (SBS) chemistry for its NGS workflow, which allows for very cost-efficient runs due to a unique combination of dark and fluorophore-labeled "terminator nucleotides." This chemistry provides state-of-the-art sequencing accuracy with difficult DNA motifs such as DNA homopolymers, which are known to be problematic for competitor sequencing chemistries.

The NGS workflow development program is on track and currently in the "verification phase" of development, with testing under way to ensure that performance and reliability match customer expectations. A version of the NGS workflow based on the modular QIAsymphony^® automation platform also is under development. In addition, QIAGEN is collaborating with SAP AG on bioinformatics efforts aimed at significantly reducing the time required for the analysis of sequencing data through the use of the SAP HANA^® platform.

New "universal" consumable NGS products launched

QIAGEN has launched two additional "universal" NGS consumable solutions that are compatible with current NGS instruments:

• GeneRead DNA Library Prep Kits - enabling DNA library preparation for NGS up to 50% faster, with high yields from samples as small as 50 nanogram
• GeneRead Size Selection Kit - a convenient and efficient NGS library preparation method

In late 2012, QIAGEN launched its NGS initiative with the introduction of four products that simplify sample preparation and save pre-analytical time, as well as nine cancer gene panels for targeted NGS analysis based on the GeneGlobe portfolio of more than 60,000 annotated molecular assays. Initial customer demand has been very strong for these products, which are "universal" and can be used on any NGS platform.

For more information on NGS products and resources visit http://www.qiagen.com/goto/NGS.

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 December 31, 2012, 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).

These products are intended for laboratory use. Not for use in diagnostic procedures. No claim or representation is made that these products are intended to provide information for the diagnosis, prevention, or treatment of disease.

Contacts:

Public Relations:
Dr. Thomas Theuringer
Director Public Relations
+49-2103-29-11826
+1-240-686-7425
Email: [email protected]

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

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

Peter Vozzo
Director, Global Investor Relations
+1-240-686-7400
Email: [email protected]
http://www.qiagen.com/about/investorrelation

SOURCE Qiagen N.V.