Roche announced that it has received the CE Mark for its Cobas Mass Spec system, including the i601 analyzer and Ionify reagent pack of four assays for steroid hormones.
In a statement, Roche said the system makes fully standardized clinical mass spectrometry more broadly available. The company plans to offer a menu of more than 60 analytes for testing steroid hormones, vitamin D metabolites, immunosuppressant drugs, therapeutic drug monitoring, and drugs of abuse that are compliant with EU in vitro medical devices regulation (IVDR), according to Roche.
"Proprietary chemistry technology developed by Roche makes commercial automation possible, with a workflow that is much more environmentally sustainable than current methods," Roche added.
"Until now, mass spectrometry has only been offered by specialist laboratories."
The Cobas Mass Spec solution will be part of Roche’s established Cobas Pro integrated solutions, which allows for its full integration into clinical chemistry and immunochemistry testing as well as lab automation and IT, the company said.
