QIAGEN expands clinical decision support for NGS in oncology labs
Nov 02 2015

QIAGEN expands clinical decision support for NGS in oncology labs

Adding solutions to QIAGEN Clinical Insight® for hereditary cancers and more somatic cancers

Redwood City, California, and Hilden, Germany, November 2, 2015 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced enhancements to its QIAGEN Clinical Insight® (QCI™) clinical decision support solution, which streamlines the annotation, interpretation and reporting of next-generation sequencing results (NGS) for clinical laboratories.

The QCI bioinformatics platform, launched earlier this year, has been expanded from interpreting NGS data on somatic mutations in solid tumor cancers to add leukemia and lymphoma testing, as well as testing for hereditary cancer indications.

Designed and validated in collaboration with clinical testing laboratories such as the Memorial Sloan Kettering Cancer Center, the Baylor College of Medicine, Virginia Commonwealth University (VCU) and LabCorp, QCI enables labs to efficiently and accurately provide the valuable molecular insights made possible by next-generation sequencing.

“While instrument and assay costs have declined, clinical testing laboratories still face bottlenecks from the complexity and cost of interpreting and reporting NGS data. Our team took a customer-centered approach to solving these challenges, collaborating with more than 50 labs to develop and validate QIAGEN Clinical Insight for each test indication. QCI has launched very successfully and is today recognized as the best-in-class decision support platform,” said Dr. Laura Furmanski, Ph.D., Senior Vice President, Business Area Bioinformatics at QIAGEN. “Our bioinformatics are having an impact in diagnostics and personalized medicine using NGS, particularly in oncology. The user-friendly QCI platform provides valuable, clinically relevant insights to help guide the treatment of patients.”

For somatic cancer indications, the QCI enhancements include insights for diagnostic testing as well as monitoring and progression, support for copy number variations (CNVs) and fusion genes, and additional prognostics data from the literature.

QCI now provides comprehensive cover of FDA- and EMA-approved drug labels, NCCN, ASCO and ESMO professional guidelines, and active genotype-related clinical trials to compliment comprehensive coverage of literature references and a wide range of reported case databases.

“We have been collaborating with QIAGEN on the design, development and validation of QIAGEN’s new Clinical Insight (QCI) platform in support of NGS-based Oncology testing”, said Dr. Andrea Ferreira-Gonzales, Ph.D., Chair, Molecular Diagnostics Division and Director of the Molecular Diagnostics Laboratory at Virginia Commonwealth University. “We recently completed our validation work with the QCI platform that demonstrated results compliant with our manual methods and reporting policies for test interpretation and reporting, with the added benefits of enabling a more scalable and repeatable standards and levels of evidence based approach. The QCI platform enables us to quickly assess biological significance, clinical relevance and actionability of observed alterations at scale and to identify treatment and trial options based upon the available levels of evidence. QCI’s comprehensive coverage of literature, reported cases and drug labels, professional guidelines and trials enables VCU to provide its ordering physicians with more insightful decision support information.”

The enhancements also add 32 hereditary cancer genes to QCI’s coverage, providing a more complete solution for laboratories to interpret and report on germline variants, including support for NGS comprehensive cancer panels testing for both somatic and inherited cancers. QCI now includes comprehensive curation of the hereditary cancer literature and curated clinical case counts for common heritable cancers including breast and ovarian cancer, Lynch syndrome, Peutz-Jegher syndrome, ataxia telangiectasia, neurofibromatosis, hereditary diffuse gastric cancer, familial prostate cancer, polyposis, and many more.

QIAGEN Bioinformatics will demonstrate QIAGEN Clinical Insight at Booth #923 at the Association for Molecular Pathology (AMP) 2015 Annual Meeting on November 5-7, 2015, in Austin, Texas. QIAGEN is a corporate partner of AMP. For information please visit http://www.qiagenbioinformatics.com/AMP

By investing in bioinformatics as a key growth driver and bringing together Ingenuity Systems, CLC bio and BIOBASE, QIAGEN has created the industry-leading provider of bioinformatics solutions and expertly curated content for the analysis, interpretation and reporting of biological data. Please visit http://www.qiagenbioinformatics.com for a demo, trial or further information about these products.


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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