PreAnalytiX, a QIAGEN and BD joint venture, launches novel solution for liquid biopsy from urine samples

PAXgene Urine Liquid Biopsy Set with collection cup and a nucleic acid stabilizing tube enables non-invasive sample collection and direct cell-free DNA stabilization from urine // QIAGEN to commercialize set with the first verified, standardized and complete preanalytical workflow from urine collection, stabilization and isolation of cell-free DNA // Cell-free DNA in urine can provide important information to data not found in blood samples

Venlo, The Netherlands, and Hombrechtikon, Switzerland, Sept. 25, 2024 (GLOBE NEWSWIRE) — PreAnalytiX GmbH, a joint venture between QIAGEN N.V. (NYSE: QGEN; Frankfurt, Prime Standard: QIA) and BD (Becton, Dickinson and Company; NYSE: BDX), today announced the launch of the PAXgene^® Urine Liquid Biopsy Set, which enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR and next-generation sequencing (NGS). The new set will be commercialized by QIAGEN.

The PAXgene Urine Liquid Biopsy Set addresses the challenge of gaining access to cfDNA from urine through an integrated preservation solution. This easy-to-use set for urine collection and cfDNA stabilization is also the first to feature a verified, standardized and complete preanalytical workflow to make urine cfDNA more accessible than ever before for research analysis.

Urine cfDNA holds great promise for research and future clinical applications. It allows to measure and analyze cfDNA fragments, detect genetic modifications and mutations, determine the methylation status, and generate genomic data not found in blood samples. However, analyzing these samples has been challenging, because cfDNA quickly degrades after sample collection and can release misleading genomic DNA.

“Cell-free DNA isolated from urine offers a truly non-invasive sampling method for liquid biopsy, but urine cfDNA requires careful sample handling,” said Dr. Ellen Heitzer, Professor at the Medical University of Graz in Austria. “The PAXgene Urine Liquid Biopsy Set enables standardized urine sampling that is easy to use in clinical practice. It is compatible with various downstream analyses including hotspot, gene panel, and genome-wide analyses – all of which can provide important complementary information to blood.”

Dr. Uwe Oelmueller, PreAnalytiX Management Committee Co-Chair and Head of MDx Development Sample Technologies at QIAGEN, commented: “With the innovative PAXgene Urine Liquid Biopsy Set, we are excited to address a pressing market need for a urine collection, stabilization, transport and storage device that is integrated into a complete preanalytical workflow for the development of cfDNA-based tests. Liquid biopsies have huge potential, but accurate results are highly dependent on the workflow. As a result, the stabilization of analyte profiles in samples is critical to ensure that test results are reliable and reproducible.”

The PAXgene Urine Liquid Biopsy Set represents a leap forward in sample quality, standardization and convenience for researchers working with urine samples. It offers a closed configuration set for urine collection and cfDNA stabilization, providing a range of options for sample shipment and storage conditions. It can be integrated into established workflows and is compatible with gold standard sample preparation products from QIAGEN. Developed according to Europe’s latest CEN/TS standard for preanalytical handling of urine for isolated cell free DNA, the set offers an optimized and standardized workflow. The CEN/TS designation refers to Technical Specifications developed by the European Committee for Standardization (CEN).

Urine liquid biopsy has a significant potential to help researchers detect minimal residual disease, monitor treatment response and identify therapeutic targets by complementing the results of blood plasma analysis and providing a more complete understanding. However, unlike for blood samples, there have been no widely established technical solutions for the collection, storage, transport and processing of urine samples – a gap the PAXgene Urine Liquid Biopsy Set will now fill.

The new PAXgene Urine Liquid Biopsy Set will complement other liquid biopsy solutions commercialized by QIAGEN, covering all analytes (circulating cell-free nucleic acids, tumor cells, exosomes) and most molecular detection technologies (NGS, qPCR, digital PCR) to empower researchers and clinicians to fully realize the potential of liquid biopsy across various applications.

Learn more about the PAXgene Urine Liquid Biopsy Set here: https://www.qiagen.com/de-us/product-categories/discovery-and-translational-research/sample-collection-stabilization/dna.

About PreAnalytiX GmbH

PreAnalytiX was formed in 1999 by QIAGEN and BD with the purpose of developing, manufacturing, and marketing integrated systems for the collection, stabilization, and purification of nucleic acids (DNA and RNA) for molecular diagnostic testing. More information about PreAnalytiX can be found at https://www.preanalytix.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 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.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services, and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to accurately detect disease, and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety, and expand access to health care. For more information on BD, please visit bd.com or connect on LinkedIn at http://www.linkedin.com/company/bd1/ and X (Twitter) @BDandCo.

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 in 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
ir@qiagen.com

Domenica Martorana
QIAGEN N.V.
+49 2103 29 11244
ir@qiagen.com

Thomas Theuringer
QIAGEN N.V.
+49 2103 29 11826
pr@qiagen.com

Lisa Specht
QIAGEN N.V.
+49 2103 29 14181
pr@qiagen.com