QIAGEN receives European IVDR certification for QIAstat-Dx syndromic testing instruments and assays
QIAGEN has received CE-marking under the new European Union IVDR framework for its QIAstat-Dx syndromic testing systems and assays. This certification includes the QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The achievement highlights QIAGEN's commitment to meeting high safety, quality, and performance standards, with 80% of over 180 products already transitioned to the new regulatory framework.
The QIAstat-Dx system uses multiplex real-time PCR technology to rapidly detect multiple pathogens simultaneously, delivering results in about one hour. By the end of 2023, more than 4,000 QIAstat-Dx systems had been installed globally, available in over 100 countries. The system is valued for its ease of use and reliable detection of various pathogens, contributing to better patient outcomes and antimicrobial stewardship.
QIAGEN ha ricevuto la marcatura CE secondo il nuovo quadro dell'IVDR dell'Unione Europea per i suoi sistemi e test di rilevamento sindromico QIAstat-Dx. Questa certificazione include il QIAstat-Dx Analyzer, QIAstat-Dx Rise e i pannelli per la rilevazione di malattie gastrointestinali e respiratorie. Questo traguardo evidenzia l'impegno di QIAGEN a soddisfare elevati standard di sicurezza, qualità e prestazioni, con l'80% di oltre 180 prodotti già transizionati al nuovo quadro normativo.
Il sistema QIAstat-Dx utilizza la tecnologia PCR in tempo reale multiplex per rilevare rapidamente più patogeni contemporaneamente, restituendo risultati in circa un'ora. Entro la fine del 2023, sono stati installati a livello globale oltre 4.000 sistemi QIAstat-Dx, disponibili in oltre 100 paesi. Il sistema è apprezzato per la sua facilità d'uso e l'affidabilità nella rilevazione di vari patogeni, contribuendo a migliorare i risultati per i pazienti e la gestione degli antimicrobici.
QIAGEN ha recibido la marcación CE bajo el nuevo marco IVDR de la Unión Europea para sus sistemas y pruebas de detección sindrómica QIAstat-Dx. Esta certificación incluye el Analizador QIAstat-Dx, QIAstat-Dx Rise y paneles para detectar enfermedades gastrointestinales y respiratorias. Este logro destaca el compromiso de QIAGEN con el cumplimiento de altos estándares de seguridad, calidad y rendimiento, con el 80% de más de 180 productos ya adaptados al nuevo marco regulatorio.
El sistema QIAstat-Dx utiliza la tecnología PCR en tiempo real multiplex para detectar rápidamente múltiples patógenos simultáneamente, entregando resultados en aproximadamente una hora. A finales de 2023, se habían instalado más de 4,000 sistemas QIAstat-Dx a nivel mundial, disponibles en más de 100 países. El sistema es valorado por su facilidad de uso y detección confiable de varios patógenos, contribuyendo a mejores resultados para los pacientes y a la gestión de antimicrobianos.
QIAGEN은 새로운 유럽연합 IVDR 프레임워크에 따라 QIAstat-Dx 증후군 테스트 시스템 및 검사의 CE 마크를 받았습니다. 이 인증에는 QIAstat-Dx 분석기, QIAstat-Dx Rise, 및 위장 및 호흡기 질병을 탐지하기 위한 패널이 포함됩니다. 이 성과는 QIAGEN이 높은 안전성, 품질 및 성능 기준을 충족하기 위한 노력의 일환이며, 180개 이상의 제품 중 80%가 이미 새로운 규제 프레임워크로 전환되었습니다.
QIAstat-Dx 시스템은 다중 실시간 PCR 기술을 사용하여 여러 병원체를 동시에 신속하게 탐지하며, 결과는 약 한 시간 내에 제공됩니다. 2023년 말까지 4,000개 이상의 QIAstat-Dx 시스템이 전 세계적으로 설치되어 100개 이상의 국가에서 사용 가능합니다. 이 시스템은 사용 편리성과 다양한 병원체를 신뢰성 있게 탐지하는 능력으로 높이 평가받아, 환자 결과 개선 및 항균 관리에 기여하고 있습니다.
QIAGEN a reçu la marquage CE dans le cadre du nouveau règlement IVDR de l'Union Européenne pour ses systèmes et tests de détection syndromique QIAstat-Dx. Cette certification inclut le QIAstat-Dx Analyzer, QIAstat-Dx Rise et les panneaux pour la détection de maladies gastro-intestinales et respiratoires. Cette réalisation met en évidence l'engagement de QIAGEN à respecter des normes élevées de sécurité, de qualité et de performance, 80 % de plus de 180 produits ayant déjà été adaptés au nouveau cadre réglementaire.
Le système QIAstat-Dx utilise la technologie PCR multiplex en temps réel pour détecter rapidement plusieurs agents pathogènes simultanément, fournissant des résultats en environ une heure. À la fin de 2023, plus de 4 000 systèmes QIAstat-Dx avaient été installés dans le monde entier, disponibles dans plus de 100 pays. Ce système est apprécié pour sa facilité d'utilisation et sa détection fiable de divers agents pathogènes, contribuant à de meilleurs résultats pour les patients et à une gestion des antimicrobiens.
QIAGEN hat gemäß dem neuen IVDR-Rahmen der Europäischen Union die CE-Kennzeichnung für seine QIAstat-Dx syndromischen Testsysteme und -assays erhalten. Diese Zertifizierung umfasst den QIAstat-Dx Analyzer, QIAstat-Dx Rise und Panels zur Erkennung von gastrointestinalen und respiratorischen Erkrankungen. Dieser Erfolg unterstreicht das Engagement von QIAGEN, hohe Sicherheits-, Qualitäts- und Leistungsstandards zu erfüllen, wobei 80% von über 180 Produkten bereits auf den neuen regulatorischen Rahmen umgestellt wurden.
Das QIAstat-Dx-System nutzt die Multiplex-Real-Time-PCR-Technologie, um mehrere Erreger simultan schnell zu erkennen, wobei die Ergebnisse in etwa einer Stunde geliefert werden. Bis Ende 2023 waren weltweit mehr als 4.000 QIAstat-Dx-Systeme installiert, die in über 100 Ländern verfügbar sind. Das System wird wegen seiner einfachen Handhabung und zuverlässigen Erkennung verschiedener Erreger geschätzt, was zu besseren Patientenergebnissen und einem verantwortungsvollen Umgang mit Antimikrobiellen beiträgt.
- CE-marking received for QIAstat-Dx syndromic testing systems and assays under new EU IVDR framework
- 80% of over 180 products already transitioned to new regulatory framework
- QIAstat-Dx system delivers results in approximately one hour
- More than 4,000 QIAstat-Dx systems installed globally by end of 2023
- Available in over 100 countries, including the U.S. and throughout Europe
- None.
Insights
The IVDR certification for QIAGEN's QIAstat-Dx systems and assays is a significant regulatory milestone. This achievement demonstrates QIAGEN's ability to meet the stringent new EU standards for in-vitro diagnostic devices, which is important for maintaining market access in Europe. The certification covers both the QIAstat-Dx Analyzer and QIAstat-Dx Rise, along with panels for gastrointestinal and respiratory infections.
Notably, the QIAstat-Dx Respiratory Panel Plus achieved Class D classification, the highest risk category under IVDR. This highlights QIAGEN's capability to meet the most demanding regulatory requirements, potentially giving them a competitive edge in the syndromic testing market.
With over 4,000 QIAstat-Dx systems installed globally by the end of 2023, QIAGEN has a substantial installed base for these products. The IVDR certification should help maintain and potentially grow this market presence, especially in Europe where compliance with the new regulation is mandatory for continued sales.
While this regulatory achievement doesn't directly impact financial metrics, it's strategically important for QIAGEN's long-term market position in Europe. The company has successfully transitioned 80% of over 180 products to the new IVDR framework, which is a significant undertaking that should help maintain revenue streams from these products in the EU market.
The QIAstat-Dx product line, now IVDR certified, is a key growth driver for QIAGEN. With installations in over 100 countries and a large installed base, it represents a substantial recurring revenue opportunity through consumable sales. The IVDR certification ensures continued access to the European market, which is important for maintaining and growing this revenue stream.
Investors should view this as a positive development that mitigates regulatory risks and positions QIAGEN well against competitors who may struggle with the new IVDR requirements. This could potentially lead to increased market share and revenue growth in the European syndromic testing market.
Product line earns CE-marking under new EU IVDR framework – including QIAstat-Dx Analyzer, QIAstat-Dx Rise and panels for detection of gastrointestinal and respiratory infections // Certification confirms that QIAGEN’s devices meet the stringent safety, quality and performance standards for in-vitro diagnostics in Europe // QIAGEN on track to transition over 180 products to new IVDR regulatory framework
Venlo, the Netherlands, Sept. 26, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).
This certification includes the widely-used QIAstat-Dx Analyzer, QIAstat-Dx Rise, and panels for detecting gastrointestinal and respiratory illnesses. The achievement underscores QIAGEN's commitment to meeting the highest standards of safety, quality, and performance, as it has already transitioned 80 percent of over 180 products to the new regulatory framework.
The new IVD regulation aims to ensure the safety, quality and effectiveness of in-vitro diagnostic (IVD) devices, overseen by independent organizations in the EU known as Notified Bodies. Devices are now classified by risk level, from A (lowest risk) to D (highest risk). The QIAstat-Dx instruments, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise, are classified as Class A devices, while the QIAstat-Dx Gastrointestinal Panel 2 is classified as a Class C device. The QIAstat-Dx Respiratory Panel Plus is classified as a Class D device – the highest risk category – highlighting QIAGEN’s capabilities to meet highest regulatory thresholds in Europe. The submission for IVDR certification of the QIAstat‑Dx Meningitis/Encephalitis Panel is expected in the coming months.
“Achieving IVDR certification for our QIAstat-Dx systems and panels is a significant milestone for QIAGEN," said Fernando Beils, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. "This certification under the new, more rigorous EU regulatory framework underscores our commitment to provide healthcare professionals with reliable and rapid syndromic testing solutions they can trust. As we continue to transition over 180 products to the IVDR framework, we remain dedicated to enhancing patient care by offering clinical customers a broad portfolio of diagnostic solutions that meet the highest standards of safety, quality, and performance.”
The QIAstat-Dx system leverages multiplex real-time PCR technology to rapidly detect and identify multiple pathogens simultaneously, delivering results in approximately one hour. It provides comprehensive data, including cycle threshold (Ct) values and amplification curves, directly on the instrument's touch screen. These fast and precise results enable healthcare providers to make informed treatment decisions, such as discontinuing unnecessary antibiotic use when viral infections are detected, thereby contributing to better patient outcomes and antimicrobial stewardship.
Available in over 100 countries, including the U.S. and throughout Europe, QIAstat-Dx solutions play a critical role in disease diagnosis worldwide. By the end of 2023, more than 4,000 QIAstat-Dx systems had been installed globally. Hospitals, laboratories, and clinics value the QIAstat-Dx range for its ease of use and reliable detection of a wide array of pathogens.
QIAstat-Dx is available in two formats: The QIAstat-Dx version that brings together up to four Analytical Modules into one integrated system, and the QIAstat-Dx Rise higher-capacity version that provides comprehensive testing for up to 160 tests per day using eight Analytical Modules.
For more information about the transition from IVDD to IVDR and the corresponding time frame, please visit QIAGEN’s IVDR support site.
Further information about QIAstat-Dx can be found on https://www.qiagen.com/de-gb/applications/syndromic-testing.
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 http://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, including those products used in the response to the COVID-19 pandemic, 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, including the breadth and duration of the COVID-19 pandemic 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
FAQ
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