QIAGEN expands automated liquid biopsy portfolio to enhance oncology, prenatal care and organ transplant applications

Portfolio expansion reinforces QIAGEN’s leadership in automated solutions for non-invasive liquid biopsy applications combined with complete workflows // New ccfDNA Kit upgrade with urine protocol for use on EZ1 and 2 instruments designed to enhance liquid biopsy workflows for cancer research // New QIAsymphony DSP Circulating DNA and Maxi Kits deliver high-quality cfDNA for use in downstream applicationsVenlo, the Netherlands, Oct. 10, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced key updates to its sample technologies solutions for non-invasive liquid biopsy applications for use in research and clinical applications such as oncology, prenatal care and organ transplantation. “The introduction of these new kits and the updates to our EZ2 Connect platform underline QIAGEN’s commitment to advancing liquid biopsy technologies,” said Nitin Sood, Senior Vice President and Head of the Life Sciences Business Area at QIAGEN. “These enhancements not only expand our portfolio to meet the diverse needs of our customers but also reinforce our leadership in providing high-quality, automated solutions in important fields such as oncology, prenatal care and organ transplant.” Liquid biopsy is a non-invasive method using biofluid samples, such as blood or urine, to detect and monitor disease biomarkers. It is promising for personalized medicine, particularly oncology, by allowing for real‑time monitoring of tumors and treatment response. QIAGEN’s broad range of solutions for liquid biopsy applications covers all analytes (circulating cell-free nucleic acids, tumor cells, exosomes) and all molecular detection technologies (next-generation sequencing (NGS), quantitative PCR, digital PCR). These updates – designed for use on the QIAsymphony and EZ2 Connect instruments – are designed to enable research and molecular diagnostics laboratories to efficiently improve results when processing larger sample volumes that are crucial for oncology research and diagnostics:  The upgraded EZ1&2 ccfDNA Kit now supports fully automated simultaneous processing of 24 samples with up to 10 mL of serum or plasma – up from the previous 8 mL – along with a new urine protocol. These enhancements are tailored for cancer research and biomarker discovery, providing higher yields of circulating cell-free DNA (ccfDNA) without manual pre-enrichment steps, and offering flexibility in downstream workflows with lower elution volumes and higher concentrations of ccfDNA. This upgrade addresses the increasing demand for larger sample input, which is essential for the detection of low-frequency mutations in liquid biopsies.  The newly introduced QIAsymphony DSP Circulating DNA Kit (96) and the QIAsymphony DSP Circulating DNA Maxi Kit (192) are fully automated kits, optimized for the extraction of ccfDNA from up to 10mL sample volume. The regular kit addresses labs which are only starting with liquid biopsy or have small sample numbers, while the Maxi Kit is tailored for labs which routinely work with liquid biopsy samples. Both kits are intended for in-vitro diagnostic (IVD) use, ensuring compliance with CE-IVDR regulations in Europe and FDA regulations in the U.S.The new QIAsymphony Kits complete QIAGEN’s automated DSP Circulating DNA product family, offering research and molecular diagnostics labs a comprehensive solution for ccfDNA isolation that supports a wide range of sample volumes and throughput needs. These kits are crucial for high-sensitivity downstream analyses like next-generation sequencing (NGS), digital PCR (dPCR), and real-time PCR, making them integral to non-invasive diagnostic procedures that benefit patients by enabling earlier and more accurate detection of conditions such as cancer. The upgrades add to the PAXgene Urine Liquid Biopsy Set recently launched by PreAnalytiX, QIAGEN’s joint venture with BD. The new set, which will be commercialized by QIAGEN, enables reliable analysis of cfDNA from urine more than ever before. For more information on QIAGEN’s liquid biopsy portfolio, visit www.qiagen.com/applications/liquid-biopsy 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 June 30, 2024, QIAGEN employed more than 5,900 people in over 35 locations worldwide. Further information can be found at https://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, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, 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; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions 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. Source: QIAGEN N.V.Category: Corporate CONTACT: John Gilardi
QIAGEN N.V.
+49 2103 29 11711
[email protected]

Domenica Martorana
QIAGEN N.V.
+49 2103 29 11244
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Thomas Theuringer
QIAGEN N.V.
+49 2103 29 11826
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Lisa Specht
QIAGEN N.V.
+49 2103 29 14181
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