PreAnalytiX, a QIAGEN and BD joint venture, launches novel solution for liquid biopsy from urine samples
PreAnalytiX, a joint venture between QIAGEN and BD, has launched the PAXgene Urine Liquid Biopsy Set, a novel solution for liquid biopsy from urine samples. This set enables non-invasive sample collection and direct cell-free DNA (cfDNA) stabilization from urine, addressing the challenge of accessing cfDNA through an integrated preservation solution.
The set features a verified, standardized, and complete preanalytical workflow for urine cfDNA analysis, compatible with various molecular testing technologies. QIAGEN will commercialize the set, which complements their existing liquid biopsy solutions. The PAXgene Urine Liquid Biopsy Set offers improved sample quality, standardization, and convenience for researchers working with urine samples, and has been developed according to Europe's latest CEN/TS standard for preanalytical handling of urine for isolated cell-free DNA.
PreAnalytiX, una joint venture tra QIAGEN e BD, ha lanciato il PAXgene Urine Liquid Biopsy Set, una soluzione innovativa per il prelievo di biopsie liquide da campioni di urine. Questo set consente la raccolta di campioni non invasiva e la stabilizzazione diretta del DNA libero da cellule (cfDNA) dalle urine, affrontando la sfida di accedere al cfDNA attraverso una soluzione integrata di preservazione.
Il set presenta un flusso di lavoro preanalitico verificato, standardizzato e completo per l'analisi del cfDNA delle urine, compatibile con varie tecnologie di test molecolari. QIAGEN commercializzerà il set, che si aggiunge alle loro soluzioni esistenti per biopsie liquide. Il PAXgene Urine Liquid Biopsy Set offre una migliore qualità del campione, standardizzazione e comodità per i ricercatori che lavorano con campioni di urine ed è stato sviluppato secondo l'ultima norma CEN/TS europea per la gestione preanalitica delle urine per il DNA libero da cellule isolato.
PreAnalytiX, una empresa conjunta entre QIAGEN y BD, ha lanzado el PAXgene Urine Liquid Biopsy Set, una solución innovadora para biopsias líquidas a partir de muestras de orina. Este conjunto permite la recolección de muestras no invasivas y la estabilización directa de ADN libre de células (cfDNA) de la orina, abordando el desafío de acceder al cfDNA a través de una solución integrada de preservación.
El conjunto presenta un flujo de trabajo preanalítico verificado, estandarizado y completo para el análisis de cfDNA en orina, compatible con diversas tecnologías de pruebas moleculares. QIAGEN comercializará el conjunto, que complementa sus soluciones existentes de biopsia líquida. El PAXgene Urine Liquid Biopsy Set ofrece una mejor calidad de muestra, estandarización y conveniencia para los investigadores que trabajan con muestras de orina y ha sido desarrollado de acuerdo con la última norma CEN/TS de Europa para el manejo preanalítico de orina para ADN libre de células aislado.
PreAnalytiX는 QIAGEN과 BD의 합작 투자로, PAXgene Urine Liquid Biopsy Set을 출시했습니다. 이는 소변 샘플에서 액체 생검을 위한 새로운 솔루션입니다. 이 세트는 비침습적인 샘플 수집과 직접적인 세포 유래 DNA(cfDNA) 안정화를 가능하게 하여, 통합된 보존 솔루션을 통해 cfDNA에 접근하는 문제를 해결합니다.
이 세트는 다양한 분자 검출 기술과 호환되는 검증된 표준화된 완전한 전처리 작업 흐름을 제공합니다. QIAGEN이 이 세트를 상용화할 예정이며, 이는 기존의 액체 생검 솔루션을 보완합니다. PAXgene Urine Liquid Biopsy Set은 소변 샘플로 작업하는 연구자들에게 샘플 품질, 표준화 및 편리함을 제공하며, 세포 유래 DNA를 위한 소변의 전처리 관리를 위한 유럽의 최신 CEN/TS 기준에 따라 개발되었습니다.
PreAnalytiX, une coentreprise entre QIAGEN et BD, a lancé le PAXgene Urine Liquid Biopsy Set, une solution novatrice pour les biopsies liquides à partir d'échantillons d'urine. Ce set permet la collecte d'échantillons non invasive et la stabilisation directe de l'ADN libre de cellules (cfDNA) à partir de l'urine, répondant au défi d'accéder à l'ADN libre de cellules via une solution de préservation intégrée.
Le set propose un flux de travail préanalytique vérifié, standardisé et complet pour l'analyse du cfDNA des urines, compatible avec diverses technologies de test moléculaire. QIAGEN commercialisera le set, qui complète ses solutions existantes de biopsies liquides. Le PAXgene Urine Liquid Biopsy Set offre une qualité d'échantillon, une standardisation et une commodité améliorées pour les chercheurs travaillant avec des échantillons d'urine, et a été développé conformément à la dernière norme CEN/TS européenne pour la gestion préanalytique des urines pour l'ADN libre de cellules isolé.
PreAnalytiX, ein Joint Venture zwischen QIAGEN und BD, hat das PAXgene Urine Liquid Biopsy Set eingeführt, eine neuartige Lösung für die flüssige Biopsie aus Urinproben. Dieses Set ermöglicht die nicht-invasive Probensammlung und die direkte Stabilisierung von zellfreiem DNA (cfDNA) aus Urin und geht die Herausforderung an, auf cfDNA durch eine integrierte Erhaltungslösung zuzugreifen.
Das Set bietet einen verifizierten, standardisierten und vollständigen präanalytischen Arbeitsablauf für die Analyse von cfDNA aus Urin, der mit verschiedenen molekularen Testtechnologien kompatibel ist. QIAGEN wird das Set kommerzialisieren, das ihre bestehenden Lösungen für flüssige Biopsien ergänzt. Das PAXgene Urine Liquid Biopsy Set bietet eine verbesserte Probenqualität, Standardisierung und Benutzerfreundlichkeit für Forscher, die mit Urinproben arbeiten, und wurde gemäß dem neuesten CEN/TS-Standard Europas für die präanalytische Handhabung von Urin für isolierte zellfreie DNA entwickelt.
- Launch of innovative PAXgene Urine Liquid Biopsy Set for non-invasive cfDNA analysis
- Addresses market need for standardized urine collection and cfDNA stabilization
- Compatible with various molecular testing technologies (qPCR, digital PCR, NGS)
- Complements QIAGEN's existing liquid biopsy solutions portfolio
- Developed according to latest European CEN/TS standards for preanalytical handling
- None.
Insights
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
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