QIAGEN launches clinical bioinformatics platform for next-generation sequencing
Redwood City, California, and Hilden, Germany, May 26, 2015 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the commercial launch of its QIAGEN Clinical Insight® (QCI™) bioinformatics content and software platform for clinical testing labs to interpret and report on genomic variants identified in next-generation sequencing (NGS). The first two supported applications for the bioinformatics platform are in oncology, for somatic and hereditary cancer testing. QIAGEN will demonstrate the QCI software at the upcoming ClinGen/DECIPHER Meeting (May 27-28, Washington D.C.), ASCO Annual Meeting (May 29-June 2, Chicago), and European Society of Human Genetics Conference (June 6-9, Glasgow).
The Clinical Insight platform is an evidence-based decision support solution that evaluates genomic variants in the context of published biomedical literature, professional association guidelines, publicly available databases and annotations, drug labels and clinical trials. Using a powerful software platform, the secure QCI web application and QIAGEN’s private data center, clinicians can rapidly classify variants, identify treatment options and perform geographical clinical trial matching. QCI is instrument- and assay-agnostic and currently supports both somatic and germline testing. It also provides access to the Allele Frequency Community, the world’s largest repository of ancestral and ethnic diversity data.
“QIAGEN Clinical Insight is the most comprehensive, scalable bioinformatics platform for clinical labs to use in interpretation and reporting of genomic variants from next-generation sequencing data. In creating this platform, we gathered input from more than 100 clinical testing labs and worked with 50 of them to evaluate the QCI content and software in their workflows for laboratory-developed tests,” said Dr. Laura Furmanski, Head of QIAGEN’s Bioinformatics Business Area. “The commercial rollout of QCI is the latest addition to QIAGEN’s portfolio of Sample to Insight solutions, including universal sample and assay consumables and a range of resources for bioinformatics that are driving the growth of next-generation sequencing for clinical research and diagnostic labs.”
One of the clinical collaborators in evaluating QCI, Dr. Gregory J. Tsongalis, Director of the Molecular Pathology and Translational Research Program at the Dartmouth-Hitchcock Medical Center, commented: “Getting from raw sequencing data to accurate and timely curation of clinically actionable variants and reporting in a user friendly format for our ordering physicians continues to be a significant challenge for complex molecular testing. Working in collaboration with QIAGEN on the development and validation of QIAGEN’s new Clinical Insight platform in support of somatic cancer testing has resulted in scalable and reproducible results in addressing our labs unmet bioinformatics needs and challenges. We look forward to continued validation work with QIAGEN and realizing the full potential of the Clinical Insight platform.”
Dr. Madhuri Hegde, Professor of Human Genetics at the Emory University School of Medicine and Executive Director of the Emory Genetics Laboratory (EGL), said: “Clinical labs developing and offering NGS-based clinical tests are confronted with two key challenges: the complexity of translating genetic information into actionable insights for ordering physicians and the time and effort it takes to interpret and report clinically relevant variants. Through its collaboration with EGL and other leading labs on the design and validation of its new QCI offering, QIAGEN has developed a deep understanding of these unmet needs. QCI supports both germline and somatic test indication which is important to labs offering diverse test indications. And it provides full platform and assay agnostic interpretation and reporting workflow support which enables clinical testing labs to reduce time and cost associated with NGS based testing.”
Bioinformatics is a key growth driver for QIAGEN. The Company’s integration of Ingenuity Systems, CLC bio and BIOBASE has created the industry-leading provider of integrated bioinformatics solutions and expertly curated content (such as Ingenuity Knowledge Base and HGMD®) for the analysis, interpretation and reporting of biological data. For information on QCI and the upcoming medical meetings, please visit qiagenbioinformatics.com/QCI-PR.
The bioinformatics platform is NOT intended as a primary diagnostic tool by physicians or to be used as a substitute for professional healthcare advice. Each laboratory is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditations requirements.
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 March 31, 2015, QIAGEN employed approximately 4,300 people in over 35 locations worldwide. Further information can be found at 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, new product developments, new product launches, regulatory submissions, and financing plans 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).