Roche secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring, further solidifying its automated in-vitro diagnostics (IVD) menu as the broadest available for any mass spectrometry platform. The platform now covers 39 of the most frequently tested targets, providing laboratories with an unparalleled combination of automation, precision, and clinical utility.
“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 optimise antibiotic use—a vital step in combating antimicrobial resistance.”
Cobas Mass Spec Solution: Integrated Automation and Accuracy
The cobas Mass Spec solution Ionify reagent portfolio now includes tests for:
*Therapeutic drug monitoring for immunosuppressants and antibiotics
*Steroid hormones
*Vitamin D metabolites
These assays help laboratories replace manual, labour-intensive workflows with fully automated, standardised solutions, boosting efficiency, accuracy, and reproducibility. Roche plans to expand the menu further. It includes drugs of abuse panels and additional therapeutic drug monitoring parameters in the coming years.
Expanding Access Across Global Markets
The cobas Mass Spec solution is now available in selected CE-marked markets, as well as in the UK, Canada, and Japan. In the US, Roche achieved “moderate complexity” CLIA categorisation for its first analyte. The first mass spectrometry assay to receive this designation. This milestone simplifies clinical adoption by eliminating the need for specialist operators. Roche continues to collaborate with global regulatory authorities to expand system and assay availability.
Mass Spectrometry: The Gold Standard in Diagnostics
Mass spectrometry stands as the diagnostic gold standard for measuring steroid hormones, vitamin D, immunosuppressants, and therapeutic drugs. The cobas Mass Spec solution combines:
*Unmatched sensitivity and specificity
*Fully automated and integrated workflows
*Seamless integration with Roche clinical chemistry, immunochemistry, and laboratory IT systems
As reported by pharmabiz.com, the approach makes mass spectrometry accessible to routine laboratories. It enables streamlined workflows and reliable results at scale.