Hilden, Germany, and Germantown, Maryland, June 20, 2019 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that QIAGEN Clinical Insight (QCI®), its clinical decision support platform for interpretation and reporting of variants derived from analysis of next-generation sequencing (NGS) data, has achieved a milestone of more than 1 million patient test cases analyzed and interpreted. The cloud-based QCI software has delivered insights to clinical laboratories and physicians in North America, Europe and the Asia-Pacific region, enabling and advancing the practice of precision medicine.
“Surpassing 1 million patient test cases is a strong validation for QCI. More than 1,000 customers worldwide have uploaded and processed patient tests, ranging from targeted panels to whole exome or genome results across multiple indications, germline to somatic cancer, to gain actionable insights from the QIAGEN Knowledge Base. This knowledge base is the industry’s most expansive collection of expert-curated biological and clinical findings built from over 20 years of manual data and literature curation, enabling deep clinical insights across a broad range of disease indications,” said Dr. Jonathan Sheldon, Senior Vice President and Head of QIAGEN’s Bioinformatics Business Area. “While handling 1 million patient cases is a monumental milestone, this is just the beginning. We are now supporting large-scale programs for precision medicine like Genomics England and the National Cancer Center Japan and are seeing the realization of our goal of using bioinformatics to make improvements in life possible.”
QCI helps advance global precision medicine efforts by providing a single evidence-based clinical decision support platform for any indication — rare and hereditary disease testing such as carrier screening, cardiovascular and hereditary cancer testing, all the way through somatic testing for solid and liquid tumors, including analysis and variant interpretation for tumor mutational burden (TMB) assays. This scalable and secure cloud-based ISO-certified platform is complemented by QIAGEN’s continued investment in technology infrastructure to support data residency requirements across various countries.
QCI provides all of the capabilities required to transform complex data from next-generation sequencing into actionable insights without the need for a customer to build a complex bioinformatics framework or high operational overhead. The two main components of the platform are QCI Analyze, automating the analysis of raw sequencing data to identify variants, and QCI Interpret, guiding the consistent and reproducible evidence-based interpretation and reporting of variants through the automation of guidelines set by industry experts such as ACMG, AMP, ASCO, and CAP.
QCI draws upon the QIAGEN Knowledge Base, a vast and still expanding collection of structured data across more than 40 scientific and clinical databases curated by MD and PhD-level certified curators. This knowledge base contains over 20 million curated findings, supporting more than 33 disease classes, reflecting the world’s collection of scientific and clinical literature, clinical trials, and drug information, as well as a growing body of real-world evidence. With more than 5,000 new data elements added daily, relevant findings are actively pushed out to QCI on a weekly basis, enabling QCI customers to remain current without the burden and expense of internal manual curation, and ultimately, report results with confidence.
QCI can analyze and interpret output from any genetic testing platform. The software is fully integrated with QIAGEN’s QIAseq and QIAact portfolio of gene panels, as well as with the GeneReader NGS System for benchtop sequencing, to deliver automated solutions from Sample to Insight.
QIAGEN is the world’s partner of choice for content-driven analytics to get actionable insights from complex molecular and real-world data. The QCI portfolio of solutions now includes N-of-One’s suite of molecular oncology decision support services: PrecisionInsights and RapidInsights for molecular oncology and GenomicInsights for biomarker discovery. This new addition strengthens QIAGEN’s offering for molecular oncology by bringing in real-world evidence-based knowledge and enables a key offering for pharma partners, delivering in-depth biomarker insights for better clinical trial protocol design and better informed companion diagnostics development.
In addition to the QIAGEN Clinical Insight family of software, QIAGEN offers the Human Genome Mutation Database (HGMD), Ingenuity Variant Analysis (IVA), CLC Genomics Workbench, OmicSoft, GeneGlobe, and other services and solutions for a variety of research and clinical needs. QIAGEN has created scalable, secure and clinically compliant infrastructure, including data centers in the United States, United Kingdom, Turkey, Japan and China. For more information, please visitwww.qiagenbioinformatics.com.
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) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found at 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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected sales, adjusted net sales and adjusted diluted earnings per share 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; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. 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).