cobas^® i 601 analyser

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Enter a new dimension in mass spectrometry

With the cobas® Mass Spec solution, which includes the cobas® i 601 analyser and the Ionify® reagents line, you can step away from tedious and complex manual mass spectrometry workflows and experience the simplicity and convenience of a streamlined end-to-end solution.

From sample preparation to result interpretation, Roche will be consolidating four technologies onto a single platform—ISE, clinical chemistry, immunochemistry, and mass spectrometry—maximising efficiency and delivering enhanced medical value. Our solution is designed to enable smart testing through seamless physical and digital connectivity with other analytical units.

A broad assay menu of Ionify reagents is in development, complementing the clinical chemistry and immunoassay portfolio available on cobas pro integrated solutions. The assays include ready-for-use test kits with consistent performance and traceability to reference methods.

Enhance your lab’s capabilities by complementing existing methodologies and expanding services to new patient populations and disease areas with mass spectrometry.^1-3 The cobas i 601 analyser allows you to streamline current workflows that require dedicated and specialised staff.

Contact us to discover how mass spectrometry can seamlessly integrate into your routine laboratory, enabling broader access to this transformative technology.

Benefits at a glance

Full automation—saving hands-on time

A total automated solution from sample preparation to result interpretation saving hands-on time for your operators.

Convenient and continuous sample loading
Random access processing: No waiting, sorting, or re-engineering required
Automated sample preparation from biological sample to purified analyte
Automated analyte separation: Automatic onboard mixing with 8 system reagents onboard and 8 channels of LC columns with efficient automated cleaning
Automated detection and quantification of analytes: Triple quadrupole mass spectrometer with electrospray ionisation (ESI) technology
Automated result validation and reporting: Data processing, analyte quantification, result validation, reporting, and flagging

Seamless integration—improving productivity

Fully integrated* into routine clinical chemistry and immunochemistry testing, as well as laboratory automation, this solution enhances productivity in your lab.

Designed to meet your laboratory’s needs, the cobas i 601 analyser is part of cobas pro integrated solutions and will work in combination* with cobas® ISE neo, cobas® c 503, and cobas® e 801 analytical units. It is also designed to integrate into pre- and post-analytics and IT solutions.

*At launch, cobas i 601 analyser is available in a single configuration <cobas pro SSU | i 601>. All other configurations will be available at a later date.

High throughput—delivering fast turnaround times

The cobas i 601 analyser has a high throughput with up to 100 injections per hour to fit the needs of your routine laboratory. This is made possible through its design features focused on automation, helping you deliver faster and more predictable turnaround times.

Broad assay menu—consolidating into one system

cobas i 601 analyser offers a broad in vitro diagnostics menu of Ionify® reagents with more than 60 assays under development in the area of steroids, vitamin D, therapeutic drug monitoring, as well as drugs of abuse testing. They will be consolidated into multi-analyte, RFID-labelled reagent cassettes, which can be easily loaded and automatically registered into the system with 48 reagent channels.

Minimum downtime—reducing maintenance efforts

The cobas i 601 analyser is designed to optimize operational efficiency and ensure seamless performance through a range of advanced features, including:

Automating the majority of maintenance tasks
Minimum daily operator intervention
Easy to perform, even for non-mass spectrometry experts
Step-by-step guidance for the operators
Continuous system monitoring to speed up troubleshooting and reduce time to repair

Traceability to reference methods—enabling consistent results

The cobas i 601 analyser, Ionify reagents, methods, and workflows comply with the In Vitro Diagnostic Medical Device Regulation (IVDR). All assay designs, including pre-analytic and analytic protocols, data acquisition, and calibration and quality controls, provide an unbroken traceability chain to reference measurement procedures. This solution ensures quality performance, enabling consistent results across laboratories and supporting better patient care.

Simplified reagent handling—ensuring safety and ease of use

With standardised, ready-for-use reagent packs, cartridges, and system reagents, the cobas i 601 analyser minimises hands-on time. This design reduces operator contact with hazardous materials, enhancing both convenience and safety.

Integrating mass spectrometry into routine testing

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If you could envision the clinical laboratory of the future, what would it look like? The cobas® Mass Spec solution brings us closer to realising that vision, enhancing support for physicians and, ultimately, benefiting patient care. Join us on this journey and discover new possibilities for your lab.

Show video transcript

If you could dream up a clinical laboratory of the future, what would it look like? The lab design, integration, and automation have always been central to Roche Diagnostics. Streamlined layouts, simplification of equipment and processes, complete automation. Over the years, we have pioneered the integration of all disciplines into the core lab. And more importantly, we connected the data. Finally, all the walls of the lab disappeared. Well, not quite.

Despite all these efforts, there is still one room that is separated from all the rest. Mass spectrometry. The advantages of mass spec are clear: superior sensitivity and specificity. Testing of metabolites and additional sample types, thus expanding the menu. But above all, it’s the quality of results that offers a competitive advantage. But at what cost?

Mass spec is extraordinarily complex, not only in technology but also in operation. It requires highly qualified personnel and continuous training. Due to the lack of integration and automation, large testing volumes are not possible, and standardisation is an issue as well, not only between laboratories but also between individual instruments. So if you were to dream of the future of clinical mass spectrometry, it would look something like this. A device with fast turnaround time, high throughput, fully automated, connected to LIS, robust with standardised ready-for-use reagents, and all this fully integrated into the core lab, just like a cobas clinical chemistry analyser. In short, it would look like…this!

The cobas Mass Spec solution. It’s a fully integrated sample-to-results solution. It has the same sample supply like all cobas pro units, including the STAT-sample port. The same cassettes design as the cobas immunochemistry analysers, with ready-for-use reagents that can be exchanged at any time, without interrupting the routine. Only very few manual tasks remain, like for example loading samples, reagents, and consumables or waste disposal, but from here on the instrument will do most of the work fully automated, like ensuring the purity of the sample during the sample preparation process by the magnetic bead-based procedure. Samples will then be automatically transported to the Liquid Chromatography Unit. Multiple streams guarantee a high throughput. The columns come in specific cartridges: ready to use and with RFID labeling. The Mass Spec-Detector. From here the data will automatically be processed and the results will be validated, using sophisticated algorithms and then sent to the LIS. In the near future, there will be a comprehensive portfolio of assays, more than 60 parameters launched in two staggered waves.

Of course, the cobas Mass Spec solution is like all the other Roche instruments in the core lab designed to run 24/7. But the best thing is the flexibility of configuration. Choose yours according to your specific needs. And finally, the cobas Mass Spec solution is fully integrated into the core lab and cobas pro integrated solutions, together with immunoassay and clinical chemistry analysers and ISE. So, in the near future, with cobas Mass Spec solution, all the walls will be gone and your dream of the laboratory of the future will have become reality for you physicians and ultimately for your patients.

White paper: Fuelling a new era of innovation in mass spectrometry

Looking at the challenges of broad access mass spectrometry diagnostics today, and outlining a vision for the future.

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Overview

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Explore the cobas i 601 analyser

cobas® i 601 analyser

Easy-to-use, fully automated, integrated, and standardised end-to-end solution bringing mass spectrometry to routine testing environments. It is part of cobas® pro integrated solutions, featuring a consistent design and user-friendly interface—reducing the need for extensive staff training.

Sample supply unit

Sample loading and unloading in a five-position rack with a capacity of up to 300 samples, allowing for continuous loading. STAT port for emergency samples.

Sample buffer

Designed to offer a true random access buffer for samples. Holds up to 25 five-position racks (125 samples). Positions can also be dedicated for STAT rack handling.

Sample preparation unit

Purification of the analytes occurs through paramagnetic particle-based sample preparation procedures, allowing automated testing in random access mode. The reagent manager consists of 48 positions in a cooled reagent rotor, enables the loading of reagent cassettes on the fly, and features an RFID reader.

Liquid chromatography unit

The system enables the separation of analytes via columns in ready-for-use cartridges with RFID labels. It incorporates both HPLC and rapid liquid chromatography (LC) technologies to cover different selectivities. Automatic onboard mixing of mobile phases and eight parallel channels of LC columns supports high throughput—up to 100 injections per hour—and allows for random access testing. Additionally, most system reagents can be loaded on the fly to maintain uninterrupted operation.

Mass spectrometry unit

Detection and quantification of the analytes occur in a triple quadrupole tandem mass spectrometer with electrospray ionisation (ESI) technology.

Scientific and expert insights

User feedback of the cobas Mass Spec solution

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User feedback of the cobas Mass Spec solution

Here feedback of the cobas^® Mass Spec solution as a lab with no previous experience of mass spec testing, from Laura Cardoso, QC Manager at Technopath Clinical Diagnostics, during IBMS Congress 2025. Laura speaks about the installation, training and daily running, as well as staff impressions of the solution.

Data from the multicenter evaluation study

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Data from the multicenter evaluation study

Joanne Bradley, Regional Product Manager cobas^® Mass Spec Solution talks through multicenter evaluation study data at IBMS Congress 2025, including analytical performance, functionality, workflow efficiency and usability.

cobas Mass Spec solution live demo

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cobas Mass Spec solution live demo

Learn more about the components and features that will revolutionise how mass spectrometry is run in clinical laboratories in this live demo from Joanne Bradley, Regional Product Manager, at IBMS Congress 2025.

Real-world performance of the cobas Mass Spec solution

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Real-world performance of the cobas Mass Spec solution

UZ Leuven’s Dr. Pieter Vermeersch and his team share how the cobas Mass Spec solution delivers precision, sensitivity, and built-in sample preparation.

Exploring the clinical value of the cobas Mass Spec solution

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Exploring the clinical value of the cobas Mass Spec solution

Prof. Dr. med. Michael Vogeser and Arber Rexhaj share how the cobas Mass Spec solution integrates into the core lab, improves workflows, and supports the shift toward more personalised clinical diagnostics.

Unlocking clinical applications of mass spectrometry

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Unlocking clinical applications of mass spectrometry

Prof. Michael Vogeser explores how the benefits of a fully automated mass spectrometry solution will translate into improved patient care.

Breaking barriers in therapeutic drug monitoring with cobas i 601 analyser

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Breaking barriers in therapeutic drug monitoring with cobas i 601 analyser

Dr. Pieter Vermeersch explores the clinical impact of automation on therapeutic drug monitoring and endocrinology.

Advancing clinical mass spectrometry with the cobas Mass Spec solution

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Advancing clinical mass spectrometry with the cobas Mass Spec solution

Learn more about the impact of standardization on the speed and accuracy of results with Prof. Robert de Jonge.

Breaking barriers in therapeutic drug monitoring with cobas i 601 analyser

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Breaking barriers in therapeutic drug monitoring with cobas i 601 analyser

Dr. Pieter Vermeersch explores the clinical impact of automation on therapeutic drug monitoring and endocrinology.

Revolutionising mass spectrometry with the fully automated cobas i 601 analyser

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Revolutionising mass spectrometry with the fully automated cobas i 601 analyser

Automation expert, Dr. Mads Nybo, discusses the impact of faster turnaround times, reduced manual work, and a broad assay menu on patient care.

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References:

Grebe SK, Singh RJ. LC-MS/MS in the Clinical Laboratory - Where to From Here?. Clin Biochem Rev. 2011;32(1):5-31.
Hristova J & Svinarov D. Enhancing precision medicine through clinical mass spectrometry platform. Biotechnology & Biotechnological Equipment. 2022;36(1):107-117.
Ketha SS, Singh RJ, Ketha H. Role of Mass Spectrometry in Clinical Endocrinology. Endocrinol Metab Clin North Am. 2017;46(3):593-613.

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cobas^® i 601 analyser

Enter a new dimension in mass spectrometry

Benefits at a glance

Integrating mass spectrometry into routine testing

White paper: Fuelling a new era of innovation in mass spectrometry

Overview

Ordering information

Technical documents