Roche receives CE Mark for new and updated molecular cobas 6800/8800 systems, enhancing laboratory efficiency and testing capabilities
Roche has received CE certification for its updated cobas 6800/8800 systems 2.0, marking a significant advancement in molecular diagnostic testing. The upgrade enhances laboratory efficiency through increased throughput, improved run flexibility, and sample prioritization capabilities. A key feature is the new Temperature-Activated Generation of Signal (TAGS) technology, enabling simultaneous detection of up to 15 targets in a single patient sample.
The systems are designed for mid-to-high volume molecular testing laboratories, offering intelligent workflows and enhanced testing capabilities. The majority of the cobas test menu is available with this update, which can be implemented as an upgrade to existing systems worldwide. FDA submission for U.S. 510(k) clearance is planned for 2025.
Roche ha ricevuto la certificazione CE per i suoi aggiornati cobas 6800/8800 systems 2.0, segnando un importante progresso nei test diagnostici molecolari. L'aggiornamento migliora l'efficienza del laboratorio grazie a una maggiore capacità di lavorazione, miglior flessibilità nelle esecuzioni e capacità di prioritizzazione dei campioni. Una caratteristica chiave è la nuova tecnologia Temperature-Activated Generation of Signal (TAGS), che consente la rilevazione simultanea di fino a 15 bersagli in un singolo campione di paziente.
I sistemi sono progettati per laboratori di testing molecolare a volume medio-alto, offrendo flussi di lavoro intelligenti e capacità di testing potenziate. La maggior parte del menu di test cobas è disponibile con questo aggiornamento, che può essere implementato come un potenziamento per i sistemi esistenti in tutto il mondo. È prevista la presentazione per la clearance FDA 510(k) negli Stati Uniti nel 2025.
Roche ha recibido la certificación CE para sus actualizados cobas 6800/8800 systems 2.0, marcando un avance significativo en las pruebas de diagnóstico molecular. La actualización mejora la eficiencia del laboratorio a través de un mayor rendimiento, una mejor flexibilidad en las ejecuciones y capacidades de priorización de muestras. Una característica clave es la nueva tecnología Temperature-Activated Generation of Signal (TAGS), que permite la detección simultánea de hasta 15 objetivos en una sola muestra de paciente.
Los sistemas están diseñados para laboratorios de pruebas moleculares de volumen medio-alto, ofreciendo flujos de trabajo inteligentes y capacidades de prueba mejoradas. La mayoría del menú de pruebas cobas está disponible con esta actualización, que puede implementarse como una mejora para sistemas existentes en todo el mundo. Se planea presentar a la FDA para la autorización 510(k) en EE. UU. en 2025.
로슈는 업데이트된 코바스 6800/8800 시스템 2.0에 대한 CE 인증을 받았으며, 이는 분자 진단 테스트에서 중요한 발전을 의미합니다. 이 업그레이드는 처리량 증가, 실행 유연성 향상 및 샘플 우선 순위 지정 기능을 통해 실험실 효율성을 향상시킵니다. 주요 특징은 단일 환자 샘플에서 최대 15개의 타겟을 동시에 감지할 수 있게 해주는 새로운 온도 활성 신호 생성(Temperature-Activated Generation of Signal, TAGS) 기술입니다.
이 시스템은 중대량 분자 테스트 실험실을 위해 설계되었으며, 지능형 작업 흐름과 향상된 테스트 기능을 제공합니다. 업데이트와 함께 대부분의 코바스 테스트 메뉴를 이용할 수 있으며, 이는 전 세계 기존 시스템의 업그레이드로 구현될 수 있습니다. 미국의 510(k) 허가를 위한 FDA 제출은 2025년으로 계획되고 있습니다.
Roche a reçu la certification CE pour ses systèmes mis à jour cobas 6800/8800 systems 2.0, marquant une avancée significative dans les tests de diagnostic moléculaire. La mise à niveau améliore l'efficacité des laboratoires grâce à un débit accru, une flexibilité de fonctionnement améliorée et des capacités de priorisation des échantillons. Une caractéristique clé est la nouvelle technologie de génération de signal activée par la température (TAGS), permettant la détection simultanée de jusqu'à 15 cibles dans un seul échantillon de patient.
Les systèmes sont conçus pour des laboratoires de test moléculaire à volume moyen à élevé, offrant des flux de travail intelligents et des capacités de test améliorées. La majorité du menu de tests cobas est disponible avec cette mise à jour, qui peut être mise en œuvre comme une amélioration des systèmes existants dans le monde entier. Une soumission à la FDA pour l'autorisation 510(k) aux États-Unis est prévue pour 2025.
Roche hat die CE-Zertifizierung für seine aktualisierten cobas 6800/8800 systems 2.0 erhalten, was einen bedeutenden Fortschritt in der molekularen Diagnosetesting darstellt. Das Upgrade verbessert die Effizienz des Labors durch erhöhten Durchsatz, verbesserte Flexibilität während der Tests und Möglichkeiten zur Priorisierung von Proben. Ein Schlüsselfeature ist die neue technologie Temperature-Activated Generation of Signal (TAGS), die die gleichzeitige Detektion von bis zu 15 Zielen in einer einzigen Patientenprobe ermöglicht.
Die Systeme sind für mittel- bis hochvolumige molekulare Test-Labore konzipiert und bieten intelligente Arbeitsabläufe sowie verbesserte Testmöglichkeiten. Die Mehrzahl des cobas-Testmenüs ist mit diesem Upgrade verfügbar, welches als Verbesserung für bestehende Systeme weltweit implementiert werden kann. Die Einreichung bei der FDA für die 510(k)-Zulassung in den USA ist für 2025 geplant.
- Introduction of TAGS technology enabling detection of up to 15 targets simultaneously
- Enhanced laboratory efficiency through increased throughput and flexibility
- Upgrade available for existing systems, reducing need for new equipment investment
- Consolidation of test menus on a single platform, optimizing resource utilization
- U.S. FDA clearance pending until 2025, limiting market accessibility
- The new cobas 6800/8800 systems 2.0 enhances throughput, run flexibility, enables sample prioritisation and is available as an upgrade to existing systems in healthcare settings around the world.
- Laboratories can now perform a wider range of tests on a single solution, simplifying laboratory logistics and helping to optimise the use of resources.
Basel, 13 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE certification of the new cobas® 6800/8800 systems 2.0. The update significantly enhances the efficiency of laboratories by optimising resources, reducing downtime, consolidating test menus, and increasing throughput. These improvements ultimately promise a more streamlined diagnostics experience for healthcare professionals and their patients.
“This update marks another significant milestone for Roche,” said Matt Sause, CEO of Roche Diagnostics. “With our history of leading innovation in automated molecular testing, it represents another competitive leap forward in our efforts to advance PCR technology by combining unprecedented throughput together with the flexibility that laboratories require to deliver for physicians and patients.”
Unified User Experience and Innovative Technologies
The majority of the cobas test menu is available with the release of the update, including the powerful new Temperature-Activated Generation of Signal (TAGS) technology. TAGS technology enables up to 15 targets to be detected simultaneously in a single patient sample on the high throughput molecular diagnostic analysers cobas 5800, 6800 and 8800 systems.
The cobas 6800/8800 systems are designed to address challenges faced by mid-to-high volume molecular testing laboratories. Bringing the latest innovations to transform the testing experience, the systems offer intelligent workflows, unrivalled throughput, proven performance, established reliability, and outstanding flexibility.
With this upgrade, the cobas family of solutions provides a unified user experience, incorporating significant innovations from the newest addition to the family, the cobas 5800 system.
The U.S. 510(k) clearance from the FDA will follow with submission planned for 2025.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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