Roche’s cobas® Mass Spec solution, including the cobas® i 601 analyzer module and the first Ionify Reagent Pack with four tests for steroid hormones², is now available on the German market. Through internal innovation, cobas® Mass Spec brings automated, integrated and standardized clinical mass spectrometry testing to routine laboratories worldwide. In the coming years, the cobas® Mass Spec solution will offer more than 60 analytes for the analysis of steroid hormones, vitamin D metabolites, immunosuppressants (ISD), therapeutic drug monitoring (TDM) and drug testing.

The high specificity, sensitivity and accuracy of mass spectrometry is considered the diagnostic “gold standard” for various clinical applications³, such as the measurement of steroid hormones in endocrinology, vitamin D testing, the monitoring of immunosuppressants and for the determination of levels of certain drugs in the blood. Examples of how mass spectrometry can benefit healthcare systems include the effective and responsible use of antibiotics and the ongoing monitoring of disease progression and treatment. The high specificity of the tests can give doctors greater clarity and can enable faster treatment decisions for patients.

“The cobas® Mass Spec solution makes fully standardized clinical mass spectrometry more widely available and has the potential to fundamentally improve patient care,” says Daniela Kahlert, Managing Director of Roche Diagnostics Germany. “There is already an established market for mass spectrometry in clinical diagnostics in Germany. This has enabled us to involve customers in the development process right from the start and to develop the product based on the needs of the laboratories. Based on this feedback, we have developed a true technological revolution – a fully automated clinical mass spectrometry solution for the routine laboratory.”

Until now, mass spectrometry has only been offered by specialist laboratories due to the low level of automation, integration and standardization as well as the high complexity of the work processes, which require highly qualified laboratory staff. This can lead to large variances between different laboratories and long turnaround times. The new laboratory technology developed by Roche makes automation possible, with a workflow that is far more efficient than current methods. The cobas® Mass Spec solution transforms the highly complex technology of mass spectrometry into an easy-to-use technology for routine testing. Thus, the solution helps to automate and standardize repetitive, high-throughput mass spectrometry parameters, allowing resources in the laboratory to be used in a targeted manner.

About the cobas® Mass Spec solution

The cobas® Mass Spec solution is a novel in-vitro diagnostics (IVD) solution that uses mass spectrometry as the measurement technology. The solution includes hardware, software, corresponding reagent packs, system reagents and consumables, providing laboratories with a comprehensive total solution. It will be part of Roche’s established cobas® pro integrated solutions, enabling full integration into clinical chemistry and immunology as well as laboratory automation and IT. cobas® Mass Spec enables complete automation from sample preparation to result interpretation using the random access method. The cobas® i 601 analyzer module is designed for the high throughput of the routine laboratory and enables fast, predictable turnaround times with up to 100 injections per hour. The first result is delivered approximately 40 minutes after start-up. The comprehensive test menu of cobas® Mass Spec with more than 60 analytes can be consolidated on a single platform with standardized performance traceable to reference methods.

To summarize:

• Roche brings mass spectrometry to the routine laboratory with the launch of the cobas® Mass Spec solution
• Clinical mass spectrometry tests offer unparalleled sensitivity and specificity, providing clinicians with additional diagnostic insights¹
• The cobas® Mass Spec solution offers a fully automated, integrated and standardized workflow with IVDR-compliant tests

Further information can be found on the Roche product page

References

[1] Hristova, J., & Svinarov, D. (2022). Enhancing precision medicine through clinical mass spectrometry platform.Biotechnology & Biotechnological Equipment, 36(1), 107-117. https://doi.org/10.1080/13102818.2022.2053342

[2] Notified Body 0123

[3] Rankin-Turner S. and Heaney L. (2023). CCLM 61, 873-879. available at https://www.degruyter.com/document/doi/10.1515/cclm-2022-0984/html, last accessed January 2025.

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