Swiss pharma MNC Roche has won CE Mark approval for its mass spectrometry reagent pack for antibiotic drug monitoring, cementing its position as the provider of the broadest in-vitro diagnostics (IVD) menu for any automated mass spectrometry platform. 

 

The new approval adds to Roche’s existing portfolio of 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."

 

The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics, as well as tests for steroid hormones and vitamin D metabolites. 

 

The fully automated system allows laboratories to move away from labor-intensive manual operations to a standardised, easy-to-use workflow. Roche plans to expand this menu in the coming years, including the first drugs-of-abuse testing panel and additional therapeutic drug monitoring assays.

 

The solution is available in select CE-mark markets and in other regions, including the United Kingdom, Canada, and Japan. Roche also achieved “moderate complexity” categorisation under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) in the US for its first analyte, making it the first mass spectrometry assay to reach this milestone—a move that opens the door for broader use in routine labs without specialist operators. 

 

Roche continues to work with regulators worldwide to expand system and assay availability.

 

Mass spectrometry, considered the diagnostic “gold standard” for testing steroid hormones, vitamin D, immunosuppressants, and therapeutic drugs, now comes with a fully automated, integrated, and standardised workflow via the cobas Mass Spec solution. 

 

Its high sensitivity and specificity, combined with seamless integration into Roche’s clinical chemistry, immunochemistry, and laboratory IT systems, streamline traditionally complex laboratory operations.