QIAGEN launches liquid biopsy workflow for GeneReader NGS System
Jun 01 2016

QIAGEN launches liquid biopsy workflow for GeneReader NGS System

Actionable Insights Tumor Panel enables monitoring of cancer biomarkers from plasma samples

Hilden, Germany, and Germantown, Maryland, June 1, 2016 – QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of its liquid biopsy workflow for clinical cancer research using QIAGEN’s GeneReader NGS System for next-generation sequencing (NGS). The Actionable Insights Tumor Panel, a member of the growing family of GeneRead QIAact Panels, is the industry’s first complete Sample to Insight NGS solution for both non-invasive liquid biopsies and FFPE tissue samples. The panel is now optimized for NGS analysis of blood plasma using proven automated QIAGEN sample technologies for circulating cell-free DNA (cfDNA), enabling both tumor characterization and monitoring of cancer resistance markers as a complement to initial tissue biopsies.

“The QIAact Actionable Insights Tumor Panel is now also available as a reliable solution for liquid biopsies, tracking a broad range of biomarkers to add valuable insights on the progression of cancers – and making NGS more accessible for any clinical cancer research laboratory using our GeneReader NGS System,” said Kai te Kaat, Vice President of QIAGEN’s Oncology Franchise. “This new application of the QIAact panel underscores QIAGEN’s leadership in liquid biopsies and our commitment to deliver on the promise of NGS. The liquid biopsy workflow, which detects hundreds of critical variants in 12 clinically actionable cancer genes, is the second QIAact panel application in our expanding menu of molecular content for the GeneReader NGS System.”

QIAGEN’s complete liquid biopsy workflow includes the Company’s Actionable Insights Tumor Panel and industry-leading liquid biopsy sample technologies for plasma, plus specialized software and bioinformatics. The solution creates a fully integrated and cost-effective workflow for testing plasma samples when formalin-fixed, paraffin-embedded (FFPE) tissue is not available or preferred. The NGS panel has demonstrated highest sensitivity of 1% in analyzing cancer variants in liquid biopsy clinical samples and Horizon control material, the industry-standard reference control data set. Bioinformatics analysis and interpretation are seamlessly integrated into the GeneReader NGS System workflow,  powered by QIAGEN Clinical Insight (QCI™), interacting with expertly-curated and proprietary knowledge databases to enable efficient interpretation of NGS variants for actionable insights.


Expanding menu for GeneReader NGS System and leadership in liquid biopsies

QIAGEN is developing additional QIAact panels to run on the GeneReader NGS System, including a lung cancer panel expected in the second half of 2016 for detection and analysis of genetic copy number variations (CNVs) from tissue and blood, and a breast cancer panel for tissue-based detection and analysis of single nucleotide variants (SNVs) and genomic insertions and deletions (INDELs). An “All-in-One” lung cancer panel is also in development, adding gene fusions to coverage of actionable variants.

The GeneReader NGS System, introduced in late 2015, is rapidly gaining worldwide adoption as a highly efficient solution to address fragmented NGS workflows and bottlenecks that have hindered many labs from achieving actionable insights from next-generation sequencing. GeneReader NGS delivers the world’s first truly complete NGS workflow from primary sample to a final report, providing a simpler, more cost-effective way for clinical research to take advantage of NGS technology and improve outcomes.

The new QIAact Liquid Biopsy workflow complements QIAGEN’s industry-leading liquid biopsy portfolio, which spans sample technologies, assay technologies and bioinformatics. QIAGEN provides gold-standard solutions for the extraction of circulating cell-free nucleic acids (cfDNA), circulating tumor cells (CTCs), and exosomes. These encompass convenient manual (including the QIAamp Circulating Nucleic Acid Kit) and automated solutions (including the QIAsymphony circulating DNA kit). In partnership with pharmaceutical companies, QIAGEN is also developing and commercializing a broad portfolio of companion diagnostics based on liquid biopsies.

 
Demonstrating Sample to Insight solutions at ASCO

As part of its broad portfolio of Sample to Insight solutions for molecular diagnostic and research applications in oncology, QIAGEN will showcase the GeneReader NGS System – including the QIAact Actionable Insights Tumor Panel and QIAGEN Clinical Insights informatics solution for NGS – at Booth 18031 at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting on June 3-7, 2016, in Chicago.

Many abstracts published at the meeting applied QIAGEN liquid biopsy solutions. For instance, in a study conducted by the University of Nantes, QIAGEN’s QIAamp Circulating Nucleic Acid Kit – in combination with QIAGEN’s therascreen BRAF assay – has demonstrated excellent performance in the detection of BRAF mutations in circulating tumor DNA of melanoma patients.

In another French study with liquid biopsies, researchers using the QIAamp Circulating Nucleic Acid Kit in tandem with the QIAGEN EGFR therascreen kit detected EGFR mutations in 27 lung-cancer patients who could not be evaluated by tissue. The study concluded that cfDNA is a relevant alternative for TKI prescription in naïve and relapsing patients when routine tissue biopsy is not available or evaluable.

For more information on QIAGEN’s presence at ASCO, visit oncologysolutions.qiagen.com/ASCO.

 

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 March 31, 2016, QIAGEN employed approximately 4,600 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

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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