Roche Launches Mass Spectrometry Analyzer

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Roche announced on Dec. 18, 2024 that it has launched its cobas Mass Spec solution upon receiving the Conformite Europeenne (CE) mark approval for the product, including its cobas i 601 analyzer and what the company noted in a press release is the first Ionify reagent pack of four assays for steroid hormones (1). The CE mark denotes the first milestone in the global launch of the cobas Mass Spec solution, which brings automated, integrated, and standardized clinical mass spectrometry testing to routine laboratories globally.

Following the launch, Roche will roll out a cobas Mass Spec solution menu offering that comprises more than 60 analytes for testing steroid hormones, vitamin D metabolites, immunosuppressant drugs (ISD), therapeutic drug monitoring (TDM), and drugs of abuse testing (DAT). The new offering will handle sample preparation through to result interpretation, and with it, Roche will be consolidating four technologies—ion selective electrode (ISE), clinical chemistry, immunochemistry, and mass spectrometry—onto a single platform, which the company expects will maximize efficiency and deliver enhanced medical value. The solution is designed to enable smart testing by leveraging physical and digital connectivity with other analytical units (2).

“The cobas Mass Spec solution will fundamentally change the field of clinical diagnostics,” said Matt Sause, CEO of Roche Diagnostics, in the press release (1). “The solution would make fully standardized clinical mass spectrometry more broadly available with the potential to improve patient care worldwide. For example, in breast cancer patients receiving hormone therapy, mass spectrometry can help physicians detect subtle changes in therapeutic response earlier, allowing for timely adjustments to treatment.”

Because mass spectrometry offers high specificity, sensitivity, and accurate analysis, it is considered the diagnostic “gold standard” for various clinical applications, such as measurements of steroid hormones in endocrinology, vitamin D testing, and the monitoring of immunosuppressants and therapeutic drugs, according to Roche in the press release. Mass spectrometry can benefit healthcare systems by, for example, monitoring the effective and responsible use of antibiotics as well as ongoing monitoring of disease progression and treatment. In addition, the high specificity of testing can provide greater levels of clarity to physicians, which would enable them to make more timely treatment decisions for patients.

In the meantime, Roche’s development of new, proprietary chemistry technology makes commercial automation possible and enables a workflow that is much more environmentally sustainable than current methods. “Until now, mass spectrometry has only been offered by specialist laboratories due to the low level of automation, integration and standardization, and the high complexity of the workflows that require highly skilled operators. This has resulted in great variability between different laboratories and long processing times,” the company stated in its release (1).

The cobas Mass Spec solution will be included in Roche’s established cobas pro integrated solutions product line, which enables full integration into clinical chemistry and immunochemistry testing as well as lab automation and IT.

References

1. Roche. Roche Transforms Mass Spectrometry Diagnostics with Launch of Cobas Mass Spec Solution. Press Release. Dec. 18, 2024.
2. Roche. cobas i 601 Analyzer. diagnostics.roche.com (accessed Dec. 24, 2024).