Evaluation confirms: QIAGEN’s new GeneReader NGS System delivers valuable clinical insights
World’s first complete Sample to Insight NGS solution proves equal or better compared with other sequencing workflows and alternative technologies
Austin, Texas, and Hilden, Germany, November 4, 2015 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that an evaluation has affirmed the performance of the Company’s GeneReader NGS System in detecting gene variants known to be clinically relevant in colorectal cancer. Results of the analysis, performed by the Broad Institute of MIT and Harvard, a leading biomedical research and sequencing center, will be presented at the Association for Molecular Pathology (AMP) 2015 Annual Meeting on November 4, 2015, in Austin, Texas.
This inquiry is the first assessment of the GeneReader NGS System’s performance in delivering insights on relevant cancer mutations in a laboratory setting. Data from the GeneReader NGS System* compared favorably with QIAGEN’s therascreen RAS mutation tests based on real-time qualitative polymerase chain reaction (PCR) and pyrosequencing, as well as with a next-generation sequencing (NGS) workflow using a competitor’s sequencer. All of the methods were used to test the same 43 tumor samples of confirmed metastatic colorectal cancer from FFPE as sample material.
“Next-generation sequencing can deliver valuable insights for clinical research and diagnostic labs, but users urgently need a simpler, more efficient and cost-effective workflow for NGS technology to enter the mainstream. QIAGEN created the GeneReader NGS System as the first complete Sample to Insight NGS solution designed for any lab to deliver actionable results – and this analysis supports that capability,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “Integrated with the most comprehensive, up-to-date knowledge base through our QIAGEN Clinical Insight software, the GeneReader NGS System is a turnkey solution that is affordable, easy to run – and delivers clinically relevant insights.”
In the analysis, data from the GeneReader NGS System were found to be 100% concordant with results of QIAGEN’s FDA approved therascreen KRAS RGQ PCR assay and the company’s CE-labelled therascreen RAS Extension Pyro Assay. In comparison to these technologies, the GeneReader workflow identified additional aberrations, enabling a more comprehensive investigation of clinically actionable variants (e.g. in the BRAF-gene). Compared to data of the other NGS workflow, which involved an Illumina MiSeq Sequencer, the GeneReader showed 100% positive agreement. Because the data generated by the QIAGEN GeneReader NGS System had fewer FFPE artifacts, it rendered a more accurate reflection of genuine somatic mutations in the samples. For the analysis, the Broad Institute used the Actionable Insights Tumor Panel, the first member of the family of GeneRead QIAact panels powered by QCI®, which was designed with the QIAGEN Knowledge Base to focus only on genes and variants with direct clinical relevance. The panel will be commercially available in the coming weeks.
The QIAGEN Clinical Insight Interpret tool builds on the QIAGEN Knowledge Base and streamlines the creation of a customizable report for each sample based on the test results, with direct links to source information on therapeutic agents, practice guidelines or clinical trials. The comprehensive test report with all the relevant information delivers actionable insights with the highest confidence and efficiency. QIAGEN’s complete NGS solution also includes a software package linking the workflow to a lab’s Laboratory Information System (LIS), enabling tracking of samples and tests, triangulation of NGS data with other results, and a holistic view of each individual case.
“We were pleased with results of the analysis, and optimistic about the System’s potential to deliver accurate and actionable data with high efficiency and low adoption hurdle”, said Dr. Scott Steelman, Associate Director of Technology Labs for the Broad Institute, who led the institute’s analysis of the new NGS workflow.
Commercialization of the QIAGEN GeneReader NGS System will be initiated at the AMP 2015 Annual Meeting, in Austin, Texas, where data from the Broad Institute analysis will be presented in a Corporate Workshop.
Time: November 4, 3:00 - 3:50pm
Speaker: Dr. Scott Steelman, The Broad Institute of MIT and Harvard
Location: Grand Ballroom E, Austin Convention Center, Austin, Texas.
For more information on the GeneReader NGS System, please visit www.GeneReaderNGS.com.
*The current version of the GeneReader NGS System is for Research Use Only
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).