QIAGEN advances precision medicine by automating guidelines on cancer variants in industry-leading QIAGEN Clinical Insight software
Nov 15 2017

QIAGEN advances precision medicine by automating guidelines on cancer variants in industry-leading QIAGEN Clinical Insight software

First bioinformatics solution integrating new AMP/ASCO/CAP standards for NGS cancer testing to confidently and quickly report clinical relevance of somatic mutations 

Hilden, Germany, and Germantown, Maryland, November 15, 2017 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today launched enhancements in its QIAGEN Clinical Insight (QCI) bioinformatics software automating the AMP/ASCO/CAP Standards and Guidelines for the Interpretation and Reporting of Sequence Variants in Cancer, advancing precision medicine with the first solution to offer molecular pathologists critical information needed to guide oncologists’ treatment decisions. Leading oncology and pathology groups published the guidelines in January 20171 in response to growing clinical implementation of next-generation sequencing (NGS) for genetic profiling of cancers. QIAGEN’s QCI-Interpret software integrates the consensus standards with a comprehensive biomedical knowledge base on potential treatments and clinical trials, guiding the selection of treatments based on the findings from each patient’s genomic testing and diagnosis. QIAGEN is launching the QCI enhancements this week at the Association for Molecular Pathology (AMP) 2017 Annual Meeting in Salt Lake City, Utah.

“As cancer genomics expands into routine clinical care, an exponential increase in next-generation sequencing studies and clinical trials makes it hard for laboratories to keep up. We have integrated the AMP/ASCO/CAP guidelines with our deep QIAGEN Knowledge Base to enable any molecular pathology lab to quickly and confidently report both the clinical relevance of somatic variants and the associated treatment options and clinical trials available to the oncologist,” said Ramon Felciano, Chief Technology Officer and Vice President, Strategy & Technology, QIAGEN Bioinformatics. “With the Association for Molecular Pathology taking the lead in cancer genomics guidelines, we’re pleased to introduce this expansion of our QCI platform at the AMP 2017 conference. QCI delivers the insights to advance precision medicine.”  

The guidelines were developed by a multidisciplinary working group from AMP with participation by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP). The guidelines establish a four-tiered system based on clinical evidence from drug labels, guidelines, and peer-reviewed publications for categorizing the clinical significance of somatic sequence variants based on evidence of their impact on cancer care.

The QCI-Interpret software integrates the AMP/ASCO/CAP tiering system into the QIAGEN Knowledge Base, a vast and expertly-curated repository of medical and scientific literature, including up-to-date information on approved drugs and clinical trials. By detailing supporting evidence for potential treatments and clinical trials, QCI-Interpret offers full transparency to clinical actionability and pathogenicity assessments. Each piece of supporting clinical evidence is rated and linked to the source publication for further study if needed. Laboratories may also change variant assessments based on their experience, tracking all changes in compliance with standard clinical procedures. QCI-Interpret is cloud-based, so labs can immediately access clinical and scientific evidence that is constantly updated by QIAGEN’s M.D. and Ph.D. staff.

1 Li, et al. 2017, Standards and Guidelines for the Interpretation and Reporting of Sequence Variants in Cancer, The Journal of Molecular Diagnostics, Vol. 19, No. 1, pages 4-23.

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.

Forward Looking Statement

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).  

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