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Press Release

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QIAGEN builds on leading position in Precision Medicine with novel solutions in oncology

May 28, 2020

• Multiple studies presented in virtual 2020 ASCO Annual Meeting highlight the impact of QIAGEN’s Sample to Insight portfolio on improving knowledge about cancer and improving patient outcomes

• QCI Interpret One combines QIAGEN Clinical Insights solutions with trusted N-of-One services to deliver gold-standard interpretation of somatic variants in cancer patients

• QIAseq Pan-cancer Multimodal panel enables an innovative approach to comprehensive and integrated profiling of multiple biomarkers in solid tumors and heme malignancies

• QIAseq Targeted Methyl panels provide the first NGS-based solutions for faster, more flexible analysis of DNA methylation designed specifically for liquid biopsy and FFPE samples

Hilden, Germany, and Germantown, Maryland, May 28, 2020 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of novel solutions enabling faster, better analysis of genomic variations in cancer – accelerating multiple applications of Precision Medicine. QIAGEN is showcasing its broad portfolio of Sample to Insight solutions for cancer in connection with the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually from May 29-31.

Among the highlights:

  • The new QCI Interpret One software solution joins the QIAGEN Clinical Insights (QCI) portfolio, which has been used to analyze and interpret next-generation sequencing (NGS) data from 1.6 million clinical cases to date. QCI Interpret One enables molecular pathologists to more rapidly and confidently deliver clinically relevant reports designed to improve patient outcomes based on complex genomic testing data.
  • The new QIAseq Pan-cancer Multimodal (1.44 Mb, 605 gene) panel for comprehensive genomic profiling (CGP) of solid tumors and heme malignancies leverages the unique QIAseq Multimodal technology which begins with a total nucleic acid extraction, followed by simultaneous preparation of DNA and RNA libraries. The Pan-cancer panel enables the detection of DNA and RNA aberrations, known and unknown RNA fusions in addition to assessment of TMB and MSI status in multiple samples types from a single sample input.
  • QIAGEN has launched the novel QIAseq Targeted Methyl panels, the first and only NGS-based products for targeted methylation analysis with the increased analytical sensitivity and sequence-targeting capabilities of the company’s proprietary Single Primer Extension technology. The solutions offer faster one-day workflows and data analysis pipelines for predesigned and custom-tailored panels in a full range of cancer applications, designed specifically for low-input samples including liquid biopsy and FFPE.

“While we serve the world’s needs for testing tools in the COVID-19 pandemic, QIAGEN also continues to deliver cutting-edge molecular solutions for cancer research and improving patient outcomes. We are fully engaged with customers in oncology, making the most of digital technologies and virtual settings such as the 2020 ASCO Annual Meeting,” said Thierry Bernard, Chief Executive Officer at QIAGEN. “Our new QCI Interpret One clinical decision support software solutions, QIAseq Pan-cancer Multimodal and QIAseq Targeted Methyl panels provide oncology researchers with valuable tools and additions for variant interpretation, liquid biopsy applications as well as comprehensive genomic profiling (CGP) and biomarker discovery. They create true Sample to Insight solutions for a variety of oncology research applications.”

Expanding QIAGEN Clinical Insights portfolio

The release of QCI Interpret One adds an important solution to the QIAGEN Clinical Insights portfolio, the clinical decision support software platform for germline, hereditary cancer and somatic interpretation and decision support. QCI Interpret One delivers variant- and disease-specific evidence for every variant in any somatic panel, backing each classification with the latest peer-reviewed publications, oncologist-reviewed interpretation summaries, and an “expert second opinion” for confident variant classification.

“The job of the molecular pathologist is more challenging than ever for variant interpretation. This is why it’s important to have access to the latest and best variant interpretive data,” said Dr. Ravindra Kolhe of Augusta University in Augusta, Georgia. “QIAGEN’s new QCI Interpret One is impressive. It combines the former N-of-One interpretation summaries with QIAGEN’s QCI Interpret structured variant interpretation database. No one is better than QIAGEN for Variant Interpretation. From a large complex panel you can quickly filter variants, classify variants according to AMP and NCCN guidelines and add disease specific and oncologist reviewed pre-formulated interpretive comments. The depth, breadth and quality quickly gives you the confidence you need when there is so much information and complexity to deal with now.”

To learn more, please visit: http://digitalinsights.qiagen.com/products/products-overview/clinical-insights-portfolio/qiagen-clinical-insight/qiagen-qci-interpret-one/.

Expanding QIAseq portfolio for multimodal applications and liquid biopsy

The new QIAseq Pan-cancer Multimodal panel for comprehensive profiling of solid tumors and heme malignancies, which enables simultaneous preparation of DNA and RNA libraries, and comprehensive detection of SNPs, indels, CNVs and RNA fusions in addition to assessment of TMB and MSI status from a single total nucleic acid sample input.

Designed to support the growing demand for workflow and assay consolidation, the QIAseq Multimodal technology enables not only the consolidation of two separate NGS-based DNA and RNA variant profiling workflows into one, but also enables scalable and parallel interrogation of up to thousands of targets in one enrichment step in one single tube. Ideal for comprehensive genomic profiling (CGP) and biomarker discovery, this 1.44 Mb panel consists of more than 600 target genes and fusions involved in the onset, progression, and treatment response across different cancer types, as well as microsatellite instability (MSI) markers, is complemented by an efficient workflow that significantly reduces hands-on and turn-around time from sample to sequencing from a typical 2-3 day workflow down to a single day.

Additionally, the innovative QIAseq Targeted Methyl panels provide valuable insights into DNA methylation, a biological process active in cancers that can modify the function of genes and affect gene expression. These flexible solutions offer faster one-day workflows and data analysis in predesigned panels for breast and colorectal cancer, immuno-oncology and T-cell infiltration (expected later in 2020), plus rapid, online custom design capabilities to create tailored panels for customer-specific applications.

To learn more, please visit https://go.qiagen.com/QIAseqMultimodal  and https://geneglobe.qiagen.com/product-groups/qiaseq-targeted-methyl-panels

Presence in ASCO20 Virtual Scientific Program

A total of 13 scientific abstracts being presented at this year’s ASCO virtual conference feature solutions from QIAGEN’s Sample to Insight portfolio for Molecular Diagnostics and research in oncology, including

  • “[Meta-analysis and single-center experience on the comprehensive genomic characterization and landscape of BRCA1 and BRCA2 in Turkey],” from [Cukurova University Faculty of Medicine, Adana, Turkey], (Abstract # e13611) [https://meetinglibrary.asco.org/record/189545/abstract]
  • “[Clinical conundrums: Developing a strategy for discerning TP53-associated chip and coherent clinical care.],” from [City of Hope, Duarte, CA; Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Boston, MA], (Abstract #1514) [https://meetinglibrary.asco.org/record/185972/abstract]

All abstracts can be found here: https://meetinglibrary.asco.org/results?meetingView=2020 ASCO Virtual Scientific Program&page=1

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, 2020, QIAGEN employed approximately 5,100 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, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected net sales, net sales of particular products, adjusted net sales, adjusted diluted earnings per share results, product launches, improvements in operating and financial leverage, currency movements against the U.S. dollar, and plans for investment in its portfolio and share repurchase commitments, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions, including the pending acquisition by Thermo Fisher Scientific Inc., may not materialize as expected; 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).

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