QIAGEN expands next-generation sequencing portfolio with oncology and immuno-oncology panels for research using GeneReader NGS System and other platforms

Sample to Insight solutions enabling deep analysis of disease-related genomic mutations

Hilden, Germany, and Germantown, Maryland, October 29, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of three innovative Sample to Insight workflows for next-generation sequencing (NGS) research in oncology using QIAGEN’s GeneReader NGS System and other NGS platforms.

QIAGEN is introducing the novel NGS workflows for clinical research in oncology at the Association for Molecular Pathology (AMP) Annual Meeting & Expo from November 1-3, 2018, in San Antonio, Texas. For details on QIAGEN’s presence at AMP 2018 please visit http://amp.qiagen.com.

Two new GeneRead QIAact panels for use on QIAGEN’s GeneReader NGS System deliver more powerful genomic insights, one covering a broad range of cancer-causing variants and the other focusing on genes tied to breast and ovarian cancers. Additionally, a new QIAseq panel is being launched for use on any NGS system to measure tumor mutational burden (TMB), an emerging biomarker for use in assessing how a patient may respond to checkpoint inhibitors, which are a form of cancer immunotherapy.

“QIAGEN’s expansion in next-generation sequencing is fueled by a significant momentum in innovation and also by partnerships with pharmaceutical companies developing companion diagnostics for their drugs. These new panels provide even deeper analysis in cancer profiling for GeneReader NGS customers and for immuno-oncology researchers, deploying best-in-class technologies for accurate detection and valuable insights,” said Peer M. Schatz, Chief Executive Officer of QIAGEN. “These new solutions are linked with our industry-leading bioinformatics for analysis and interpretation, which are delivering actionable insights to support clinical researchers worldwide. As NGS moves toward increasingly routine use, laboratories are turning to QIAGEN’s Sample to Insight solutions to achieve valuable insights with best-in-class efficiency, accuracy and ease of use.”

New oncology workflows for GeneReader

The two new Sample to Insight workflows for the GeneReader NGS System deliver powerful analysis by expanding gene coverage and variant types and using QIAGEN’s proprietary “Digital NGS” technology to enable more accurate quantification, detection and interpretation of variants.

The new workflows involve:

  • The GeneRead QIAact Actionable Insights Tumor (AIT) DNA UMI panel broadens coverage from 12 to 30 genes influencing development and progression of the most widespread cancers, including lung, melanoma, prostate and other solid tumors. The workflow targets more than 850 DNA variants in hotspot regions as well as 125 full exons.
  • The GeneRead QIAact BRCA Advanced UMI panel enables analysis of the full exon coding sequences of the BRCA1, BRCA2, TP53 and PTEN genes, which play key roles in the development and progression of breast, ovarian and other cancers. The workflow will enable alignment with National Comprehensive Cancer Network (NCCN) guidelines (Genetic/Familial High-Risk Assessment: Breast and Ovarian) on the need for comprehensive testing that encompasses full BRCA1/2 sequencing and detection of large gene rearrangements.

A highlight of the new solutions is detection of copy number variations (CNVs) down to exon-level as well as of larger deletions, which are pathogenic but often overlooked by NGS technologies lacking an optimized end-to-end solution. The seamlessly integrated GeneReader system effectively detects CNVs, as well as alterations in non-coding intronic DNA regions, which can undermine the body’s tumor suppressor genes.

Like all new panels for the GeneReader NGS System, the GeneRead QIAact assays come with a pre-optimized and pre-verified sample-to-report workflow, including all steps from sample extraction to variant interpretation with QIAGEN Clinical Insight (QCI) Interpret (research use only). Integration with QCI Interpret leverages the expertly curated QIAGEN Knowledge Base to provide most up-to-date interpretation of variants using international guidelines for variant classification. This enables labs to much more quickly detect and interpret hundreds of DNA mutations that can influence the development and progression of cancer.

Open-platform immuno-oncology panel

The new QIAseq TMB Panel represents a most advanced breadth of markers related to immune-oncology-related biomarkers and thereby provides in-depth analysis of emerging biomarkers with potential to predict responses to immunotherapy in advanced cancers, such as the growing class of checkpoint inhibitor drugs.

The QIAseq TMB Panel is designed to run on any commercial NGS platform, and the workflow targets variants in 486 genes covering full exons. In a single panel, QIAseq TMB detects tumor mutational burden (TMB), the total number of mutations in coding areas of a tumor genome; microsatellite instability (MSI), a predisposition to genetic mutations due to impaired DNA repair capability; single nucleotide variants (SNVs), changes in a single strand of DNA; and Indels, small insertions or deletions in DNA.

The QIAseq TMB Panel efficiently generates data with higher sensitivity and lower requirements for DNA input (40 ng) than whole exome or smaller targeted panels for research applications. Like other QIAseq workflows, the panel incorporates unique molecular indexes (UMIs), tagging every molecule in a sample at an early stage to eliminate errors in downstream analysis and produce higher-quality results. With the launch of the new panel QIAGEN expands its footprint in immuno-oncology, which is further strengthened by improvements in QIAGEN’s QCI Interpret’s somatic cancer clinical decision support application that now enables interpretation and reporting of TMB and MSI.

QIAGEN is a partner in the Friends of Cancer Research consortium, which has been working for more than a year to harmonize analysis and reporting standards for clinical researchers evaluating TMB and MSI in cancer patients samples. The QIAseq panel delivers harmonized reporting in digital form and in variant call format (.vcf files) for ease of use by pharmaceutical and other researchers using TMB data in clinical research.

The QIAseq TMB Panel is being launched at the AMP Annual Meeting and will also be discussed in presentations on head-to-head studies in pre-conference sessions on November 6, 2018, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Washington, DC.

QIAGEN’s presence at AMP 2018 (October 31 – November 3, 2018, in San Antonio, Texas)

At this year’s annual AMP meeting, around 50 scientific abstracts will feature solutions ranging across QIAGEN’s Sample to Insight workflow. QIAGEN will demonstrate novel Sample to Insight solutions, including the NeuMoDx 96 and QIAstat diagnostic systems recently launched in Europe, and meet with AMP attendees in Booth #607. In addition, QIAGEN will present three corporate-sponsored workshops on October 31:

  • 2:00-2:50 p.m. – “A complete end-to-end NGS solution for clinical cancer research
  • 3:00-3:50 p.m. – “Improving syndromic respiratory testing with QIAGEN’s DiagCORE system
  • 4:00-4:50 p.m. – “Identification of inherited genetic risk factors of pancreatic cancer using a targeted sequencing approach in a large cohort

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 (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2018, QIAGEN employed approximately 4,900 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 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).

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