Roche Strengthens Mass Spec Leadership With Latest CE Mark Approval

Roche has announced fresh momentum in clinical diagnostics with CE Mark approval for its new mass spectrometry reagent pack, a move that strengthens its position in mass spectrometry testing.

The approval expands what is now the broadest IVD menu available for any automated mass spectrometry platform, covering 39 of the most commonly tested targets.

“When patients get results sooner, we increase the likelihood that they will get the right treatment,” said Matt Sause, CEO of Roche Diagnostics. “With a comprehensive menu for automated mass spectrometry, we are giving clinicians and laboratories the tools to make faster, more precise diagnoses, reducing the time from sample to result. This approach also allows clinicians to better monitor the effectiveness of drug therapies and to optimise antibiotic use, a vital step in combating the major global healthcare challenge of antimicrobial resistance."

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The Ionify reagent portfolio for the cobas Mass Spec solution includes tests for therapeutic drug monitoring of immunosuppressants and antibiotics, along with steroid hormones and vitamin D metabolites. By shifting from manual workflows to a fully automated setup, labs gain a standardized and easier way to run complex assays. Roche plans to grow this portfolio, including its first drugs-of-abuse panel and additional therapeutic drug monitoring assays.

The cobas Mass Spec solution is available in CE Mark markets, as well as the United States, the United Kingdom, Canada, and Japan. In the U.S., Roche also secured a “moderate complexity” CLIA categorization for its first analyte, marking the first mass spectrometry assay to earn this designation.