Roche has announced that its cobas® Mass Spec solution, including the cobas® i 601 analyzer and the first Ionify® reagent pack for steroid hormone assays, has received CE mark approval. This marks a significant step in the global rollout of the cobas Mass Spec solution, which aims to bring automated, integrated, and standardized clinical mass spectrometry testing to routine laboratories worldwide. The solution will initially offer over 60 analytes for steroid hormone testing, vitamin D metabolites, immunosuppressant drugs, therapeutic drug monitoring (TDM), and drugs of abuse testing (DAT).
The cobas Mass Spec solution is designed to revolutionize clinical diagnostics by making high-sensitivity, high-specificity mass spectrometry more accessible. According to Matt Sause, CEO of Roche Diagnostics, it has the potential to significantly improve patient care. For instance, in breast cancer patients undergoing hormone therapy, the solution can help detect early therapeutic response changes, enabling timely treatment adjustments.
Mass spectrometry is widely regarded as the diagnostic gold standard for various clinical applications, including endocrinology, vitamin D testing, and monitoring immunosuppressant and therapeutic drug levels. It provides clear, accurate results, which enable healthcare providers to make more informed, timely decisions for patients, such as optimizing antibiotic use and monitoring disease progression.
Roche’s proprietary chemistry technology has made it possible to automate mass spectrometry, addressing the challenges of low automation, high complexity, and variability that have previously limited its use to specialized labs. The cobas Mass Spec solution integrates seamlessly into Roche’s cobas® pro platform, supporting clinical chemistry, immunochemistry testing, and lab automation. This integration enhances workflow efficiency and environmental sustainability, bringing mass spectrometry to a wider range of clinical settings.