QIAGEN’s GeneReader NGS System gains further validation in oncology research applications with new independent performance review data

Studies presented at AMP Global conference in Berlin reaffirm powerful analytical performance and ease of use for the world’s first complete Sample to Insight NGS solution

Hilden, Germany, April 3, 2017 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced further validation of the GeneReader NGS System with the publication of five new independent studies that reaffirm the analytical performance and ease in using the world’s first complete Sample to Insight solution that makes the benefits of next-generation sequencing (NGS) accessible to any laboratory.

The studies*, which are being presented this week at the Global Congress on Molecular Pathology (AMP Global 2017) in Berlin, demonstrated the performance of the GeneReader System in oncology research applications to generate insights from cancer tumor samples collected from both FFPE (formalin-fixed paraffin-embedded) and non-invasive liquid biopsies. The studies also reviewed implementation of the complex NGS technology, and that the GeneReader NGS System was identified as a feasible solution that can be replicated by laboratories with limited resources. (The current version of the GeneReader NGS System is for Research Use Only.)

“These findings from users in the United States and Europe show the value of the GeneReader NGS System as a simple, cost-effective way for laboratories around the world to take advantage of this powerful technology. In a variety of cancers and sample types, these studies show the GeneReader System compares well against alternative platforms and offers unique benefits as the only fully integrated NGS workflow,” said Dr. Kai te Kaat, Vice President and Head of QIAGEN’s Oncology Franchise in the Molecular Diagnostics Business Area. “Our Sample to Insight solution provides everything a lab needs for a complete end-to-end NGS workflow, and one that offers increasing flexibility and utility with the range and we will continue to demonstrate the utility of the GeneReader System to achieve actionable insights.”

 

Among the independent customer abstracts published at the AMP Global Berlin conference:

  • Researchers at Dartmouth-Hitchcock Medical Center in the U.S. tested 30 unique samples from lung, colon, melanoma and GIST tumors on the GeneReader  NGS System, and found 100% concordance in actionable variants compared with a competitor benchtop NGS solution. The study also found high reproducibility of results in testing 19 duplicate samples. The abstract is No. ST19: “Detection and Classification of Clinical Tumor Variants Using the QIAGEN GeneReader NGS System.”

 

  • Researchers at Cornell University in the U.S. used the GeneReader NGS System to test 59 tumor FFPE sections from various tissue sources involving thyroid, colon, lung, pancreas, melanoma and colorectal cancers with previously known mutational status and using the Actionable Insights Tumor panel and QCI-Analyze bioinformatics solution. They concluded that the GeneReader NGS System was well-positioned for laboratories desiring to implement NGS technology. The abstract is No. TT19: “Applications of the GeneReader NGS System in Clinical Testing of Tumor Samples.”

 

  • Researchers at the CBmed Center for Biomarker Research in Medicine in Graz, Austria, applied the GeneReader NGS System to assess a diverse set of samples involving colon and melanoma cancers using the Actionable Insights Tumor Panel that covers 12 clinically actionable genes and analyzed with the QCI-Analyze bioinformatics solution. The results showed that all variants were correctly identified and interpreted, showing the robustness of the GeneReader NGS System and its flexibility and reliability handling different sample types and sources. The abstract is No. OTH01: “Application of the GeneReader NGS System in Analyzing a Diverse Set of Cancer Clinical Samples.”

 

  • Researchers at the University of Erlangen-Nuremberg in Germany undertook an analysis of EGFR mutation testing in a cohort of patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC) using cell-free DNA as a liquid biopsy on the GeneReader NGS System, and among the findings recommended further studies. The abstract is No. TT12: “Liquid Biopsy: EGFR mutation testing using cell-free DNA and the GeneReader Workflow in a cohort of patients with advanced EGFR-mutant NSCLC.”

In addition, three abstracts are being presented that were submitted by QIAGEN teams and partners:

  • Abstract No. ST21: “Using GeneReader NGS System to Identify Germline and Somatic Mutations in BRCA 1/2 Genes,” by researchers at QIAGEN and HalioDX in France.

 

  • Abstract No. ST20: “Application of Liquid Biopsy to Uncover Critical Cancer Insights Using the GeneReader NGS System,” by researchers at QIAGEN.

 

  • Abstract No. TT10: “A Full Process Control for Setting up an NGS Operation Using the GeneReader NGS System,” by researchers at QIAGEN.

During 2017, QIAGEN is rolling out system enhancements designed to significantly improve the utility, efficiency and cost-effectiveness of the GeneReader NGS System. These include plans for at least five new GeneRead QIAact gene panels compatible with both FFPE and liquid biopsies. In a move that will significantly broaden the use for oncology research applications, QIAGEN also plans to soon offer services to customers for the development of customized gene panels for use on the GeneReader NGS System. QIAGEN’s gene panels have also been upgraded to incorporate the proprietary Digital NGS technology that enables more accurate quantification and detection of variants in samples. The GeneReader NGS System is being expanded to analyze a broader range of genetic variant types that include large rearrangements (in particular exon-skipping events), gene fusions and copy number variations (CNVs), in addition to current capabilities for single nucleotide polymorphisms (SNPs), gene expression and genomic insertions or deletions (InDels).

For more information, please visit http://www.qiagen.com/us/products/ngs/mdx-ngs-genereader/ngs/.

AMP Berlin information (April 3-5, 2017)

QIAGEN will demonstrate Sample to Insight solutions – including the GeneReader NGS System – at Booth 26a at the Global Congress on Molecular Pathology (AMP Global 2017) from April 3-5, 2017, in Berlin. An industrial workshop, “GeneReader: A complete NGS System for Your Lab, Live in 30 Days,” will be held from 15:15-16:15 local time on April 5 in Room 1. For more details on QIAGEN’s presence at AMP Global, visit http://oncologysolutions.qiagen.com/2017/03/03/qiagen-at-amp-global-2017/.

*Some data contained in these scientific works may have been created using legacy chemistry or may reference such data. Legacy chemistry is available outside the United States only. Upgraded chemistry is available to customers in the United States.


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 December 31, 2016, QIAGEN employed approximately 4,700 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 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 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).

Kathryn Collinet

Kathryn Collinet, PhD, is a Technical and Marketing Writer for Personalized Healthcare and Oncology at QIAGEN. She trained as a molecular biologist at the University of Barcelona and the Institute for Research in Biomedicine, where she studied DNA and protein modifications and their influence on chromatin conformation and gene expression. Since 2011 Kathryn has been working in marketing communications for the scientific information and molecular diagnostics industries. Kathryn has a passion for delivering knowledge and insights about molecular and clinical technologies, and their power to impact research and healthcare.

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