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

Rhea-AI Summary

Roche (OTCQX: RHHBY) announced U.S. launch of cobas 6800/8800 systems version 2.0 and software v2.0.1 after FDA 510(k) clearance earlier in 2025. The upgrade increases assay flexibility (unique assays per run 3→6), allows up to 6 assays per sample, and supports simultaneous LDT and IVD testing. A second analytic unit option for cobas 6800 can boost throughput to 2,112 tests/day. The update is available as a software upgrade to existing systems and aims to reduce downtime, consolidate test menus, and address staffing and cost pressures while modernizing the user interface.

Positive

• Assays per run increased from 3 to 6
• Up to 6 assays can be run per sample
• Throughput up to 2,112 tests per day with second analytic unit

Negative

• None.

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• 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

FAQ

What did Roche announce on December 16, 2025 about cobas 6800/8800 (RHHBY)?

Roche launched cobas 6800/8800 systems version 2.0 and software v2.0.1 in the U.S. following FDA 510(k) clearance earlier in 2025.

How does the cobas 2.0 update change throughput for RHHBY customers?

The update increases assays per run to 6 and a second analytic unit on cobas 6800 can raise throughput to 2,112 tests per day.

Can existing cobas 6800/8800 systems be upgraded to version 2.0?

Yes, the announcement states the improvements are available as a software upgrade to existing systems.

Does the cobas 2.0 update support both LDT and IVD testing on RHHBY systems?

Yes, the release allows simultaneous running of Laboratory Developed Tests (LDT) and In-Vitro Diagnostic (IVD) assays.

What operational issues does the cobas software v2.0.1 aim to address for labs?

The update aims to reduce downtime, consolidate test menus, improve flexibility, and help address staffing shortages and rising costs.

Will the cobas 2.0 release change the user interface for molecular testing labs?

Yes, the update includes a modernized user interface and a unified user experience across the cobas molecular portfolio.