The approval expands the company’s automated mass spectrometry menu to 39 tests.
Roche has secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring. The approval brings Roche’s cobas mass spec solution Ionify reagent portfolio to 39 tests, including therapeutic drug monitoring for immunosuppressants and antibiotics, along with steroid hormones and vitamin D metabolites.
“When patients get results sooner, we increase the likelihood that they will get the right treatment,” says Matt Sause, CEO of Roche Diagnostics, in a release. “With a 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.”
The expanded menu allows laboratories to transition from manual operations to a fully automated, standardized solution. Sause notes that the approach also enables clinicians to better monitor drug therapy effectiveness and optimize antibiotic use, which he calls “a vital step in combating the major global healthcare challenge of antimicrobial resistance.”
Regulatory Progress and Market Availability
The cobas Mass Spec solution is currently available in selected markets accepting the CE mark, as well as the United Kingdom, Canada, and Japan. In the US, Roche achieved “moderate complexity” categorization under the Clinical Laboratory Improvement Amendments of 1988 for its initial analyte.
Roche plans to expand the menu with additional assays in coming years, including its initial panel in drugs of abuse testing and further therapeutic drug monitoring parameters. The company continues working with regulatory authorities worldwide to expand system and assay availability.
