Dec. 20, 2024—Roche announced it has received CE mark approval for its Cobas Mass Spec solution, including the Cobas i 601 analyzer and Ionify reagent pack of four assays for steroid hormones. The CE mark is the first milestone in the global launch of the Cobas Mass Spec solution, Roche said in a press statement. Following the launch, the company will roll out a menu of more than 60 analytes for testing of steroid hormones, vitamin D metabolites, immunosuppressant drugs, therapeutic drug monitoring, and drugs of abuse testing.
“The Cobas Mass Spec solution will fundamentally change the field of clinical diagnostics,” Matt Sause, CEO of Roche Diagnostics, said in the statement. “The solution would make fully standardized clinical mass spectrometry more broadly available with the potential to improve patient care worldwide. For example, in breast cancer patients receiving hormone therapy, mass spectrometry can help physicians detect subtle changes in therapeutic response earlier, allowing for timely adjustments to treatment.”
The Cobas Mass Spec solution will be part of Roche’s Cobas Pro integrated solutions, which allow for full integration into clinical chemistry and immunochemistry testing as well as lab automation and IT.