- Roche's mass spectrometry platform now includes 39 tests for drug monitoring and other diagnostics.
- The CE Mark approval covers antibiotics drug monitoring, enhancing lab efficiency.
- The cobas Mass Spec solution is available in CE mark markets, UK, Canada, and Japan.
- Roche plans to expand the menu with drugs of abuse testing and more therapeutic drug monitoring assays.
CE Mark Approval
Roche has secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring. This approval expands Roche's in-vitro diagnostics menu to include 39 tests, making it the broadest available for any automated mass spectrometry platform.
Enhanced Diagnostic Capabilities
The comprehensive menu includes tests for therapeutic drug monitoring of immunosuppressants and antibiotics, as well as steroid hormones and vitamin D metabolites. This advancement brings the sensitivity and specificity of gold-standard testing into routine labs, improving diagnostic accuracy and efficiency.
Automation and Efficiency
The fully automated cobas Mass Spec solution replaces labor-intensive manual workflows, reducing turnaround times and supporting faster, standardized, high-quality care. It allows laboratories to transition to a fully automated, standardized, and easy-to-use solution.
Global Availability and Future Plans
The cobas Mass Spec solution is available in selected markets accepting the CE mark, including the UK, Canada, and Japan. Roche is working with regulatory authorities to expand system and assay availability globally. Future plans include expanding the menu with additional assays, such as the first panel in drugs of abuse testing and more therapeutic drug monitoring parameters.
