Roche receives CE Mark for new and updated molecular cobas 6800/8800 systems, enhancing laboratory efficiency and testing capabilities
Rhea-AI Summary
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.
Positive
- 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
Negative
- U.S. FDA clearance pending until 2025, limiting market accessibility
News Market Reaction 1 Alert
On the day this news was published, RHHBY declined 0.51%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- 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.
All trademarks used or mentioned in this release are protected by law.
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FAQ
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