Roche announces U.S. launch of next-generation cobas 6800/8800 systems and software, enhancing laboratory efficiency and testing capabilities

• The new cobas^® 6800/8800 Systems version 2.0 and software version 2.0.1 enhances throughput, run flexibility, enables sample prioritization and is available as an upgrade to existing systems.
• Laboratories can now perform a greater variety of tests per run, simplifying laboratory logistics and helping to optimize the use of resources.
• The update addresses critical industry challenges, such as staffing shortages, rising costs and menu fragmentation, while optimizing the user experience across the cobas molecular portfolio.

INDIANAPOLIS, Dec. 16, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the new cobas^® 6800/8800 systems version 2.0 and software version 2.0.1, following U.S. Food and Drug Administration (FDA) 510(k) clearance earlier this year. The update greatly enhances the efficiency of laboratories by optimizing resources, reducing downtime, consolidating test menus and increasing throughput. These improvements support a more streamlined diagnostics experience for healthcare professionals and their patients.

"This update is significant because it not only allows for new innovation in PCR-testing technology and more choices in omni-channel testing, but it also addresses some key improvements that customers have told us are high priorities for them," said Brad Moore, President and CEO, Roche Diagnostics North America. "All of these updates and improvements can be made to existing 6800/8800 systems through the software upgrade, providing higher throughput to laboratories with the same footprint and delivering more flexibility to physicians and patients."

Unified User Experience and Innovative Technologies
The majority of the cobas test menu is available with the release of the 2.0 update, which delivers significant enhancements in throughput, flexibility, efficiency and system security, along with a modernized user interface. New features include an increase in unique assays per run (from three to six) and the flexibility to run up to six assays per sample, maximizing throughput with a broader assay menu. A key advantage is the ability to simultaneously run both Laboratory Developed Tests (LDT) and In-Vitro Diagnostic (IVD) assays, simplifying laboratory logistics.

Additionally, the option for a second analytic unit on cobas 6800 systems boosts throughput up to 2,112 tests per day, supporting testing volume and variety. This enables labs to keep up with the increased demand for testing and adapt quickly to shifting priorities without disrupting workflows or impacting productivity.

The cobas 6800/8800 systems are designed to address challenges faced by mid- to high-volume molecular testing laboratories. With this upgrade, the cobas family of molecular solutions provides a unified user experience, incorporating key innovations from the newest addition to the family, the cobas^® 5800 system.

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 personalized 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.

For Further Information

Roche Diagnostics U.S. Media Relations

Krystina Monaco
1-317-850-7521
krystina.monaco@roche.com 

Lori McLaughlin
1-463-207-2395
lori.mclaughlin@roche.com 

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SOURCE Roche Diagnostics