QIAGEN expands automated liquid biopsy portfolio to enhance oncology, prenatal care and organ transplant applications
QIAGEN has announced key updates to its sample technologies solutions for non-invasive liquid biopsy applications. These enhancements are designed for use in research and clinical applications such as oncology, prenatal care, and organ transplantation. The updates include:
1. An upgraded EZ1&2 ccfDNA Kit that now supports processing of 24 samples with up to 10 mL of serum or plasma, along with a new urine protocol.
2. New QIAsymphony DSP Circulating DNA Kit (96) and QIAsymphony DSP Circulating DNA Maxi Kit (192) for fully automated extraction of ccfDNA from up to 10mL sample volume.
These updates are designed to improve results when processing larger sample volumes, important for oncology research and diagnostics. The new kits are intended for in-vitro diagnostic (IVD) use, complying with CE-IVDR and FDA regulations.
QIAGEN ha annunciato aggiornamenti chiave alle sue soluzioni tecnologiche per campioni per applicazioni di biopsia liquida non invasiva. Questi miglioramenti sono progettati per l'uso in applicazioni di ricerca e cliniche come oncologia, assistenza prenatale e trapianto d'organo. Gli aggiornamenti includono:
1. Un Kit EZ1&2 ccfDNA aggiornato che supporta ora l'elaborazione di 24 campioni con fino a 10 mL di siero o plasma, insieme a un nuovo protocollo per l'urina.
2. Nuovi Kit QIAsymphony DSP Circulating DNA (96) e Kit QIAsymphony DSP Circulating DNA Maxi (192) per l'estrazione completamente automatizzata di ccfDNA da un volume campione fino a 10 mL.
Questi aggiornamenti sono progettati per migliorare i risultati durante l'elaborazione di volumi di campione più grandi, importanti per la ricerca e la diagnostica oncologica. I nuovi kit sono destinati a un uso diagnostico in vitro (IVD), conformi alle normative CE-IVDR e FDA.
QIAGEN ha anunciado actualizaciones clave a sus soluciones de tecnologías de muestras para aplicaciones de biopsia líquida no invasiva. Estas mejoras están diseñadas para su uso en aplicaciones de investigación y clínicas como oncología, atención prenatal y trasplante de órganos. Las actualizaciones incluyen:
1. Un Kit EZ1&2 ccfDNA actualizado que ahora admite el procesamiento de 24 muestras de hasta 10 mL de suero o plasma, junto con un nuevo protocolo para orina.
2. Nuevos Kit QIAsymphony DSP Circulating DNA (96) y Kit QIAsymphony DSP Circulating DNA Maxi (192) para la extracción totalmente automatizada de ccfDNA a partir de un volumen de muestra de hasta 10 mL.
Estas actualizaciones están diseñadas para mejorar los resultados al procesar volúmenes de muestra más grandes, importantes para la investigación y diagnóstico en oncología. Los nuevos kits están destinados para uso en diagnóstico in vitro (IVD), cumpliendo con las regulaciones CE-IVDR y FDA.
QIAGEN은 비침습적 액체 생검 응용 프로그램을 위한 샘플 기술 솔루션에 대한 주요 업데이트를 발표했습니다. 이러한 개선은 종양학, 산전 관리 및 장기 이식과 같은 연구 및 임상 응용 프로그램에서 사용하도록 설계되었습니다. 업데이트 내용은 다음과 같습니다:
1. 이제 24개의 샘플을 최대 10 mL의 혈청 또는 플라즈마로 처리할 수 있도록 지원하는 EZ1&2 ccfDNA 키트의 업그레이드와 새로운 소변 프로토콜이 포함됩니다.
2. 최대 10mL 샘플 부피에서 ccfDNA를 완전 자동화하여 추출할 수 있는 새로운 QIAsymphony DSP 순환 DNA 키트 (96)와 QIAsymphony DSP 순환 DNA 매키 키트 (192)가 출시되었습니다.
이러한 업데이트는 종양학 연구 및 진단에 중요한 더 큰 샘플 부피를 처리할 때 결과를 개선하기 위해 설계되었습니다. 새로운 키트는 체외 진단(IVD) 용도로 사용되며, CE-IVDR 및 FDA 규정을 준수합니다.
QIAGEN a annoncé des mises à jour clés de ses solutions technologiques d'échantillons pour des applications de biopsie liquide non invasive. Ces améliorations sont conçues pour une utilisation dans des applications de recherche et cliniques telles que l'oncologie, les soins prénatals et la transplantation d'organes. Les mises à jour comprennent :
1. Un Kit EZ1&2 ccfDNA amélioré qui prend désormais en charge le traitement de 24 échantillons avec jusqu'à 10 mL de sérum ou de plasma, ainsi qu'un nouveau protocole pour l'urine.
2. Nouveaux Kit QIAsymphony DSP Circulating DNA (96) et Kit QIAsymphony DSP Circulating DNA Maxi (192) pour l'extraction entièrement automatisée de ccfDNA à partir d'un volume d'échantillon allant jusqu'à 10 mL.
Ces mises à jour ont été conçues pour améliorer les résultats lors du traitement de volumes d'échantillons plus importants, ce qui est important pour la recherche et le diagnostic en oncologie. Les nouveaux kits sont destinés à un usage diagnostique in vitro (IVD), conformes aux réglementations CE-IVDR et FDA.
QIAGEN hat wichtige Updates für seine Probe-Technologielösungen für nicht-invasive Flüssigbiopsie-Anwendungen angekündigt. Diese Verbesserungen sind für die Verwendung in Forschungs- und klinischen Anwendungen wie Onkologie, pränatale Betreuung und Organtransplantation konzipiert. Die Updates umfassen:
1. Ein aufgerüstetes EZ1&2 ccfDNA-Kit, das nun die Verarbeitung von 24 Proben mit bis zu 10 mL Serum oder Plasma unterstützt, sowie ein neues Urinprotokoll.
2. Neue QIAsymphony DSP Kreislauf-DNA-Kits (96) und QIAsymphony DSP Kreislauf-DNA Maxi-Kits (192) für die vollautomatische Extraktion von ccfDNA aus bis zu 10 mL Probenvolumen.
Diese Updates sind darauf ausgelegt, die Ergebnisse bei der Verarbeitung größerer Probenvolumina zu verbessern, was für die Forschung und Diagnostik in der Onkologie wichtig ist. Die neuen Kits sind für den In-vitro-Diagnosetests (IVD) vorgesehen und entsprechen den CE-IVDR- und FDA-Vorschriften.
- Expansion of automated liquid biopsy portfolio reinforces QIAGEN's leadership in the field
- New kits support processing of larger sample volumes (up to 10 mL) for improved detection of low-frequency mutations
- Introduction of fully automated kits for ccfDNA extraction optimized for different lab needs and sample volumes
- New products comply with CE-IVDR and FDA regulations for in-vitro diagnostic use
- None.
Insights
QIAGEN's expansion of its automated liquid biopsy portfolio represents a significant advancement in non-invasive diagnostic technologies. The upgraded EZ1&2 ccfDNA Kit now allows for processing larger sample volumes (up to 10 mL) and includes a new urine protocol, which is important for improving the detection of low-frequency mutations in cancer research. This enhancement addresses a critical need in the field, as larger sample inputs can significantly increase the sensitivity of liquid biopsy tests.
The introduction of the QIAsymphony DSP Circulating DNA Kits for in-vitro diagnostic use is particularly noteworthy. These kits, compliant with CE-IVDR and FDA regulations, offer scalability for labs of different sizes and throughput needs. This regulatory compliance is essential for clinical adoption and could accelerate the integration of liquid biopsy tests into standard care protocols.
The focus on automating ccfDNA isolation across various sample volumes positions QIAGEN as a leader in providing comprehensive liquid biopsy solutions. This could potentially lead to earlier and more accurate detection of cancer and other conditions, ultimately improving patient outcomes through personalized medicine approaches.
QIAGEN's portfolio expansion in the liquid biopsy market is strategically significant. The global liquid biopsy market is projected to grow at a CAGR of
The introduction of IVD-compliant kits is particularly important from a financial perspective. These products can command higher margins due to their regulatory approval and clinical utility. Moreover, they create opportunities for recurring revenue streams as labs adopt QIAGEN's platforms for routine diagnostic use.
With a market cap of
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 applications
Venlo, 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
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