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

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) has 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.