QIAGEN Inc. Introduces GeneReader NGS System

AUSTIN, Texas and HILDEN, Germany, November 4, 2015 /PRNewswire/ --

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the start of commercialization activities for its GeneReader NGS System, the first complete Sample to Insight next-generation sequencing (NGS) solution designed for any laboratory to deliver actionable results.

With the introduction of the GeneReader NGS System*, QIAGEN is offering the world’s first truly end-to-end NGS workflow from primary sample to a final report that provides a simpler, more cost-effective way for clinical testing to take advantage of NGS technology and improve outcomes.

The first application for the GeneReader NGS System involves QIAGEN’s new Actionable Insights Tumor Panel, the first member of the family of GeneRead QIAact Panels powered by QCI^®. This novel gene panel targets 12 clinically actionable genes that are often analyzed in most prevalent types of cancer, including breast, ovarian, colorectal, lung and melanoma. The panel can detect up to 1,250 different genetic mutations in a tumor sample. The most relevant variants - including those which are part of approved drug labels, reimbursement schemes, professional guidelines and active phase III clinical trials - have been identified and selected using the QIAGEN Knowledge Base, the industry’s largest collection of human-curated genomic findings and scientific literature.

QIAGEN will demonstrate this integrated Sample to Insight™ workflow at the Association for Molecular Pathology (AMP) 2015 Annual Meeting from November 4-7 in Austin, Texas, where commercialization of the GeneReader NGS System will be initiated. An analysis conducted by the Broad Institute of MIT and Harvard demonstrating the accuracy of the GeneReader NGS System through a head-to-head comparison with other molecular testing systems, including FDA-approved PCR assays and NGS systems, also will be presented at the AMP meeting. QIAGEN will also highlight its expanding range of therascreen companion diagnostics and leading liquid biopsy solutions at the conference.

“We designed the GeneReader NGS System with its integrated Sample to Insight workflow for clinical labs that see the potential of next-generation sequencing but urgently need a more user-friendly, cost-effective workflow for their use and research. GeneReader is the first fully integrated NGS workflow purpose-built to deliver actionable insights to improve outcomes,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “Our initial turnkey solution delivers a seamless NGS process with harmonized solutions from Sample to Insight. Because QIAGEN is the only company with a complete product suite across all relevant workflow steps, we can provide a unified solution that transforms each primary sample into a comprehensive and actionable report. Customers can partner with QIAGEN to unlock the power of NGS - from Sample to Insight.”

The GeneReader NGS System offers laboratories solutions for key challenges in next-generation sequencing:

• The world’s first truly complete NGS workflow: Labs can rely on one partner to provide a seamlessly integrated workflow offering ease of use and efficiency from sample to insight.
• Actionable insights: Customers can create relevant reports using QIAGEN’s proven gene panels and bioinformatics.
• Flexibility to fit customer needs: Scalable batch sizes and continuous loading of multiple flow cells enable labs to adapt and scale the GeneReader NGS System to match their needs and grow.
• Guaranteed results with predictable costs: Innovative commercial models such as price-per-insight options offer labs better cost management and low initial investment hurdles.
• Proven expertise and service for our customers: QIAGEN supports customers in efficiently implementing, validating and operating the GeneReader NGS System in their labs.

QIAGEN’s Actionable Insights Tumor Panel, the core assay for the GeneReader NGS System, was built on extensive experience with the Company’s line of GeneRead^[TM] DNAseq V2 panels, already in use in many NGS workflows to target a comprehensive range of cancer-related genes or regions. As shown in the analysis by the Broad Institute, results of the Actionable Insights Tumor Panel running on the GeneReader NGS System are concordant with other methods such as FDA-approved PCR assays and CE-IVD pyrosequencing assays that are used in many laboratories, as well as with other NGS sequencing platforms.

The GeneReader NGS System and the family of GeneRead QIAact Panels powered by QCI^® integrate seamlessly with QIAGEN Clinical Insight (QCI™), the Company’s clinical decision support solution for labs. The system’s bioinformatics solution accesses the industry’s most comprehensive, up-to-date knowledge base to automate and streamline annotation, interpretation and reporting of results, including treatment options and annotations to the relevant literature. QCI, designed and validated in collaboration with clinical testing laboratories, overcomes a major challenge for labs by increasing the accuracy and speed of analyzing and interpreting NGS results.

QIAGEN also is developing a range of upgrades and enhancements that will add further value for labs that adopt the GeneReader NGS System. In the near term, QIAGEN plans to introduce additional cancer-related gene panels, broadening the coverage in oncology. QIAGEN also expects to expand the NGS content menu to indications beyond oncology. The platform also will evolve, as necessary, to address new applications and market segments, with current development programs targeting throughput expansion, increased output per flow cell, and an expanded range of sample types, including non-invasive liquid biopsies. QIAGEN bioinformatics solutions are continuously updated, including updates of the Knowledge Base.

*The current version of the GeneReader NGS System is for Research Use Only

For more information on the GeneReader NGS System and the GeneRead QIAact Panel, please visit http://www.GeneReaderNGS.com.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions to transform biological materials into valuable molecular insights. QIAGEN sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective molecular testing workflows. QIAGEN provides these workflows to more than 500,000 customers around the world in 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, 2015, QIAGEN employed approximately 4,500 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).

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