QIAGEN launches QIAcuityDx digital PCR system for clinical testing in oncology
QIAGEN has launched the QIAcuityDx Digital PCR System, expanding its digital PCR portfolio into clinical diagnostics. The system is 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe. It provides precise, absolute quantitation of target DNA and RNA, supporting liquid biopsy applications and cancer monitoring.
Key features of QIAcuityDx include:
- All-in-one instrument for IVD assays and lab-designed tests
- User-friendly software with IVD and Utility modes
- Flexible scheduling and continuous sample loading
- Processing of up to four nanoplates simultaneously
- Reduced lab space requirements and processing times
QIAGEN plans to expand the application menu, with a BCR::ABL assay for oncohematology planned for FDA submission in 2025. The company has also signed three partnerships for companion diagnostics development.
QIAGEN ha lanciato il QIAcuityDx Digital PCR System, ampliando il suo portafoglio di PCR digitale nella diagnostica clinica. Il sistema è esente da 510(k) negli Stati Uniti e certificato IVDR per l'uso diagnostico in Europa. Fornisce quantificazione precisa e assoluta del DNA e RNA target, supportando applicazioni di biopsia liquida e monitoraggio del cancro.
Le caratteristiche principali del QIAcuityDx includono:
- Strumento tutto-in-uno per saggi IVD e test progettati in laboratorio
- Software user-friendly con modalità IVD e Utility
- Pianificazione flessibile e caricamento continuo dei campioni
- Elaborazione di fino a quattro nanoplati contemporaneamente
- Riduzione delle esigenze di spazio in laboratorio e dei tempi di lavorazione
QIAGEN prevede di espandere il menu delle applicazioni, con un saggio BCR::ABL per oncoematologia previsto per la presentazione alla FDA nel 2025. L'azienda ha anche firmato tre partnership per lo sviluppo di diagnostica di accompagnamento.
QIAGEN ha lanzado el QIAcuityDx Digital PCR System, ampliando su cartera de PCR digital en el diagnóstico clínico. El sistema es exento de 510(k) en EE. UU. y está certificado por IVDR para uso diagnóstico en Europa. Proporciona cuantificación precisa y absoluta de ADN y ARN objetivo, apoyando aplicaciones de biopsia líquida y monitoreo del cáncer.
Las características clave del QIAcuityDx incluyen:
- Instrumento todo-en-uno para ensayos IVD y pruebas diseñadas en laboratorio
- Software fácil de usar con modos IVD y Utility
- Programación flexible y carga continua de muestras
- Procesamiento de hasta cuatro nanoplacas simultáneamente
- Reducción de requisitos de espacio en laboratorio y tiempos de procesamiento
QIAGEN planea ampliar el menú de aplicaciones, con un ensayo BCR::ABL para oncohematología previsto para presentación a la FDA en 2025. La empresa también ha firmado tres asociaciones para el desarrollo de diagnósticos de acompañamiento.
QIAGEN은 QIAcuityDx 디지털 PCR 시스템을 출시하여 임상 진단용 디지털 PCR 포트폴리오를 확장했습니다. 이 시스템은 미국에서 510(k) 면제 및 유럽에서 IVDR 인증을 받았습니다. 목표 DNA 및 RNA의 정확하고 절대적인 정량화를 제공하여 액체 생검 응용 프로그램과 암 모니터링을 지원합니다.
QIAcuityDx의 주요 기능은 다음과 같습니다:
- IVD 검사 및 실험실 설계 테스트를 위한 올인원 장치
- IVD 모드 및 유틸리티 모드를 갖춘 사용자 친화적인 소프트웨어
- 유연한 스케줄링 및 지속적인 샘플 로딩
- 최대 4개의 나노플레이트를 동시에 처리
- 연구실 공간 요구 사항 및 처리 시간 단축
QIAGEN은 2025년 FDA 제출을 목표로 하는 온코혈액학용 BCR::ABL 검사를 포함하여 응용 프로그램 메뉴를 확장할 계획입니다. 또한 동반 진단 개발을 위한 세 가지 파트너십을 체결했습니다.
QIAGEN a lancé le QIAcuityDx Digital PCR System, élargissant son portefeuille de PCR numérique dans le diagnostic clinique. Le système est exempt de 510(k) aux États-Unis et certifié IVDR pour un usage diagnostique en Europe. Il offre une quantification précise et absolue de l'ADN et de l'ARN cibles, soutenant les applications de biopsie liquide et le suivi du cancer.
Les caractéristiques clés du QIAcuityDx comprennent :
- Un instrument tout-en-un pour les tests IVD et les tests conçus en laboratoire
- Un logiciel convivial avec des modes IVD et Utility
- Une planification flexible et un chargement continu des échantillons
- Un traitement pouvant aller jusqu'à quatre nanoplates simultanément
- Des besoins réduits en espace de laboratoire et des temps de traitement réduits
QIAGEN prévoit d'élargir le menu des applications, avec un test BCR::ABL pour l'oncohématologie prévu pour soumission à la FDA en 2025. L'entreprise a également signé trois partenariats pour le développement de diagnostics d'accompagnement.
QIAGEN hat das QIAcuityDx Digital PCR System eingeführt, das sein digitales PCR-Portfolio in der klinischen Diagnostik erweitert. Das System ist in den USA 510(k)-befreit und in Europa IVDR-zertifiziert für diagnostische Anwendungen. Es bietet präzise, absolute Quantifizierung von Ziel-DNA und RNA, unterstützt flüssige Biopsieanwendungen und Krebsmonitoring.
Zu den wichtigsten Funktionen des QIAcuityDx gehören:
- All-in-One-Gerät für IVD-Tests und laborgestaltete Tests
- Benutzerfreundliche Software mit IVD- und Utility-Modi
- Flexible Planung und kontinuierliches Probenladen
- Verarbeitung von bis zu vier Nanoplates gleichzeitig
- Reduzierte Laborraumbedürfnisse und Verarbeitungszeiten
QIAGEN plant, das Anwendungsmenü zu erweitern, mit einem BCR::ABL-Test für Onkohämatologie, der 2025 bei der FDA eingereicht werden soll. Das Unternehmen hat auch drei Partnerschaften zur Entwicklung von Begleitdiagnostika unterzeichnet.
- Expansion into clinical diagnostics market with 510(k) exempt and IVDR-certified system
- Partnerships with three pharmaceutical companies for companion diagnostics development
- Planned FDA submission for BCR::ABL assay in 2025
- Strong adoption of QIAcuity research instrument with over 2,000 cumulative placements by end of 2023
- Citations in over 450 publications for QIAcuity digital PCR research instrument
- None.
Insights
The launch of QIAcuityDx Digital PCR System marks a significant advancement in clinical diagnostics, particularly for oncology. This system offers absolute quantitation of DNA and RNA targets, which is important for monitoring low-abundance biomarkers in cancer progression. The technology's ability to work with liquid biopsies is a key advantage, potentially reducing the need for invasive procedures.
The system's 5-plex workflow and integration of multiple processes into a single instrument streamline laboratory operations, potentially reducing costs and improving efficiency. The planned BCR::ABL assay for oncohematology, slated for FDA submission in 2025, could be particularly impactful for leukemia monitoring.
QIAGEN's partnerships for companion diagnostics development suggest a strong move towards precision medicine. This could lead to more targeted therapies and improved patient outcomes in oncology. The system's flexibility in supporting both IVD assays and laboratory-developed tests (LDTs) provides versatility for clinical labs, potentially accelerating adoption.
However, the true impact will depend on the expansion of the assay menu and successful regulatory approvals. The
Expands range of applications for successful QIAcuity digital PCR platforms, now entering the clinical space across North America and the EU // Provides absolute quantitation, essential for precise monitoring of low-abundance targets in clinical diagnostics // Enhances lab efficiency and reduces costs with all-in-one instrument for either IVD assays or tests designed and used by laboratories, user-friendly software and flexible scheduling features
Venlo, the Netherlands, Sept. 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAcuityDx Digital PCR System, a pivotal addition to its digital PCR portfolio now expanding into clinical diagnostics. The instrument and accessories are 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe.
QIAcuityDx streamlines clinical testing by providing highly precise, absolute quantitation of target DNA and RNA, supporting applications with less invasive liquid biopsies. These capabilities make it an ideal tool for monitoring cancer progression, complementing routine cancer diagnoses, which are typically performed using Next Generation Sequencing (NGS).
QIAGEN is rapidly expanding the application menu available on QIAcuityDx-System, with a new BCR::ABL assay for oncohematology planned for FDA submission in 2025. The platform also provides immediate access to QIAGEN’s full portfolio of research-use products and applications via its GeneGlobe platform. QIAGEN has already signed three partnerships with pharmaceutical companies to develop companion diagnostics on the QIAcuityDx, moving digital PCR into precision medicine. In addition, QIAGEN plans to further enhance the future assay portfolio by collaborating with third parties, who will develop their own assays for the platform.
“With the QIAcuityDx, we are bringing our precise and efficient digital PCR platform into the clinical space, reflecting our commitment to meeting the evolving needs of clinical labs in monitoring and minimal residual disease testing during patient treatment,” said Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. “By integrating all necessary functions into a single device, we are simplifying workflows and reducing operational costs for clinical labs, while instilling confidence in highly accurate and reliable diagnostic results.”
“The QIAcuityDx is a compact benchtop technology that doesn't take up much space and is very easy to use. The run is short, so you get results really fast. It provides a report that is digestible, translatable, and meaningful, and makes it easy to make decisions,” said Dr. Kate Brown, translational research manager at The Christie NHS Trust in Manchester, United Kingdom, when asked about the clinical implications of QIAcuityDx for patients. Dr. Brown has used QIAcuityDx as part of a collaborative lung cancer study with QIAGEN.
“It enables us to improve the testing workflow. It allows us to quantify what's happening, to gain true insight into how the tumor is changing, how the molecular basis of that tumor is responding to treatment. And that is something that other existing technologies are unable to offer,” she added.
The QIAcuityDx platform is an IVD medical device that integrates partitioning, thermocycling, and imaging into a streamlined 5-plex workflow within a single instrument, eliminating the need for additional equipment. Capable of processing up to four nanoplates simultaneously, it reduces lab space requirements, servicing needs, and operator time. Labs familiar with QIAcuity can expect the same easy and fast nanoplate-based workflow, which disperses a sample into thousands of tiny partitions and then reads reactions simultaneously to quantify even the faintest signals from DNA and RNA.
QIAcuityDx’s technology enables higher throughput, allows for imaging of partitions, improves precision and sensitivity, cuts processing times to just two hours, and reduces the risk of cross-contamination – crucial factors for applications like oncology and infectious diseases.
QIAcuityDx software is designed for diagnostic use, featuring a user-friendly interface and comprehensive audit trail compliant with modern lab requirements. It includes two modes:
- An IVD mode offering validated assay plug-ins and automated analysis.
- A Utility Mode, providing flexibility to laboratories for their laboratory-developed tests (LDTs) and research applications.
The QIAcuity-DX platform supports continuous sample loading and flexible scheduling, accommodating urgent testing needs without compromising patient results. To ensure diagnostic compliance and meet clinical customer needs, QIAcuityDx will include:
- A bi-directional LIMS (Laboratory Information Management System) interface for seamless integration with electronic patient records.
- QIAcuityDx-optimized universal master mix and nanoplates manufactured under strict regulatory standards.
- A validated installation process supporting lab compliance with an audit-ready report.
- 5-channel calibration enhancing image processing and reproducibility.
The adoption of QIAcuity digital PCR research instrument is strong, with more than 2,000 cumulative placements at the end of 2023 and citations in over 450 publications. Key customers include pharmaceutical and biotechnology companies, academic and research organizations and forensic laboratories. QIAcuityDx will now address additional customer segments, further strengthening the footprint of the QIAcuity family.
For more information on QIAcuityDx and to enhance your lab’s diagnostic capabilities, visit https://www.qiagen.com/de-us/products/instruments-and-automation/pcr-instruments/qiacuity-dx-mdx
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 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
FAQ
What is the QIAcuityDx Digital PCR System launched by QIAGEN (QGEN)?
When is QIAGEN (QGEN) planning to submit the BCR::ABL assay for FDA approval?
How many partnerships has QIAGEN (QGEN) signed for companion diagnostics on QIAcuityDx?
What are the key features of QIAGEN's (QGEN) QIAcuityDx Digital PCR System?
