Roche (RHHBY,RO.SW,ROG.SW) announced that it has obtained CE Mark approval for its mass spectrometry reagent pack designed for antibiotics drug monitoring. This milestone establishes Roche's in-vitro diagnostics (IVD) menu as the broadest available for any automated mass spectrometry platform, now covering 39 of the most frequently tested targets.
The cobas Mass Spec solution Ionify reagent portfolio includes assays for therapeutic drug monitoring of immunosuppressants and antibiotics, as well as tests for steroid hormones and vitamin D metabolites. By offering a fully automated, standardized, and easy-to-use solution, Roche enables laboratories to move away from labor-intensive manual operations. The company remains committed to expanding this menu with additional assays, including the first drugs of abuse testing panel and further therapeutic drug monitoring parameters.
Currently, the cobas Mass Spec solution is available in selected markets that accept the CE mark, along with other regions such as the United Kingdom, Canada, and Japan. In parallel, Roche has achieved "moderate complexity" categorization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its first analyte in the United States.
Roche said it continues to collaborate with regulatory authorities worldwide to further expand the availability of its system and assays, reinforcing its commitment to advancing diagnostic innovation.
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