QIAGEN : GeneReader NGS System delivers accuracy and ease of use for clinical research in oncology

Hilden, Germany, and Germantown, Maryland, November 14, 2017 - QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced new studies highlighting the outstanding analytical performance and ease of use of the GeneReader NGS System, the world's first complete Sample to Insight solution for next-generation sequencing. The studies are being presented this week at the Association for Molecular Pathology (AMP) 2017 Annual Meeting in Salt Lake City, Utah, where QIAGEN also will demonstrate the GeneReader and other Sample to Insight solutions.

Two poster presentations outline studies describing the high accuracy of QIAGEN's new GeneRead QIAact BRCA1/2 panel and the GeneReader NGS platform for detection of pathogenic mutations in tumor suppressor genes in breast cancer. Two other studies illustrate the high accuracy and overall effectiveness of using QIAGEN's Actionable Insights Tumor Panel (AIT) and the GeneReader system to detect cancer-causing mutations both in tissue samples and in liquid biopsies. About 10 percent of the more than 500 papers being presented at AMP 2017 feature QIAGEN solutions for diverse challenges of molecular testing.

'We are very excited about the feedback from leaders in the clinical research community describing the unique value of the GeneReader NGS System. As the world's only integrated, end-to-end solution for next-generation sequencing, GeneReader offers proven accuracy and ease of use. QIAGEN is rapidly expanding our content menu with ultra-accurate gene panels for breast and lung cancer, as well as driving the launch of our very successful customized panels and thereby offering access to an unlimited content offering,' said Dr. Kai te Kaat, Vice President and Head of QIAGEN's Oncology Franchise in the Molecular Diagnostics Business Area. 'The GeneReader solution provides everything a lab needs to take advantage of the power of NGS, plus the versatility to analyze molecular variants across all major sample types. We are very proud to be enabling labs around the world to achieve actionable insights in NGS.'

Among the posters at the AMP 2017 conference that focus on the GeneReader system:

• The high accuracy of the GeneReader system and AIT panel were described in testing of 50 formalin-fixed, paraffin-embedded (FFPE) tissue samples and 20 liquid biopsies for mutations in the BRAF, EGFR, KRAS and NRAS genes. Researchers at the Academic Teaching Hospital Feldkirch in Austria observed 100% agreement between the GeneReader analysis and two other methods. (Abstract No. ST07: 'A verification study of the GeneReader NGS System in a routine laboratory setting,' presentation from 9:45-10:45 a.m. Saturday November 18 in the Exhibit Hall.) 'The GeneReader NGS system provides a solution with low hands-on time, high performance and accuracy in the detection of relevant mutations,' the Feldkirch researchers noted. QIAGEN Clinical Insight bioinformatics software provides 'an easy tool for data analysis, variant interpretation and quality control,' they added. 'In summary, the GeneReader NGS system is easy to implement in daily routine and provides an accessible technology for molecular laboratories.'

• Researchers at Quiron Dexeus University Hospital in Barcelona, Spain, tested the GeneReader NGS System and AIT panel against two other methods of DNA analysis on 104 FFPE tissue samples, 43 FFPE reference samples and 86 liquid biopsies. They found 100% concordance in the FFPE and reference samples and 89.3% concordance in the blood samples. (Abstract No. ST58, 'Application of the GeneReader NGS System in Testing of Actionable Mutations in Tumor and Blood Samples,' presentation from 2:30 p.m. to 3:30 p.m. Friday November 17 in the Exhibit Hall.)

• Data presented by QIAGEN researchers demonstrates the ability of the GeneRead QIAact BRCA 1/2 Advanced Panel running on the GeneReader NGS System to accurately and efficiently detect all possible actionable DNA mutations in the breast cancer suppressor genes BRCA 1/2, PTEN and TP53. This new panel detects mutations at single-nucleotide resolution for every coding exon, not just at hotspots. (Abstract No. G18, 'Using the GeneReader NGS System to Identify Mutations in BRCA 1/2, PTEN and TP53,' presentation from 2:30 p.m. to 3:30 p.m. Friday November 17 in the Exhibit Hall.)

• Researchers at the Hungarian Academy of Sciences and Semmelweis University in Budapest, Hungary, demonstrated the GeneReader's effectiveness in detecting inherited BRCA mutations in a patient with a rare cancer and her family members. (Abstract No. G21, 'BRCA1 Mutation Detection Using QIAGEN GeneReader NGS System in a Case with RET Codon 634 Mutation,' presentation from 9:45-10:45 a.m. Saturday November 18 in the Exhibit Hall.) The Semmelweis researchers concluded: 'A fully integrated system including sample preparation, automation and bioinformatics analysis and interpretation, the GeneReader System offers an easy solution for laboratories interested in genetic analysis.'

QIAGEN's presence at AMP 2017 (November 15-18, 2017)

QIAGEN will demonstrate Sample to Insight solutions - the GeneReader NGS System, the modular QIAsymphony automation system, and universal solutions for liquid biopsy and other sample types - in Booth #707 at the AMP 2017 meeting from Thursday November 16 to Saturday November 18. In addition, QIAGEN will present three corporate-sponsored workshops on Wednesday November 15:

• 9:00-9:50 a.m. - 'A Molecular Pathology Lab's Experience using NGS Panels & QCI Interpret for Variant Interpretation and Reporting Using AMP Guidelines'

• 10:00-10:50 a.m. - 'Actionable Insights, Delivered - The GeneReader NGS System for Easy NGS Implementation and Accurate Variant Detection in Cancer Research'

• 11:00-11:50 a.m. - 'Leading the Liquid Biopsy Revolution: Case Example of an Operational Genomics Workflow in a Molecular Pathology Lab'

For details on QIAGEN's presence at AMP 2017, visit http://amp2017.qiagen.com/.

The GeneReader NGS System is purpose-built with the flexibility and reliability to meet all critical demands of the clinical research market, from Sample to Insight. In 2017, QIAGEN has been rolling out enhancements to significantly improve the utility, efficiency and cost-effectiveness of the GeneReader. The capabilities of this unique system also include high-sensitivity detection in liquid biopsy samples, compatibility with the QIAsymphony SP automation platform for higher-throughput sample processing. QIAGEN has added molecular content - new GeneRead QIAact gene panels compatible with both FFPE and liquid biopsies - plus a service to develop customized panels for customers' specific requirements. Integrated bioinformatics provide streamlined, cloud-based analysis and interpretation of NGS data. To learn more, visit http://www.qiagen.com/us/products/ngs/mdx-ngs-genereader/.

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

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our 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 workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2017, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Certain statements contained in this press 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, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on crrent 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 to customers in academia, pharma, applied testing and 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 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).