NEW YORK – Roche on Wednesday announced that it has received CE marking for its new mass spectrometry solution comprising the Cobas I 601 analyzer and Ionify reagent pack of four tests for steroid hormones.
Roche said in a statement that it also plans to roll out a menu of more than 60 analytes for testing steroid hormones, vitamin D metabolites, immunosuppressant drugs, therapeutic drug monitoring, and drugs of abuse testing. The company also said that its proprietary chemistry enables an automated workflow that is more environmentally sustainable than current methods.
Roche has been developing the platform for more than 10 years and the CE marking is the first step in its global launch. The company previously said it would launch the solution in the US in 2025. The mass spec platform will be included in Roche's Cobas Pro integrated solutions, which enables full integration into clinical chemistry and immunochemistry testing, along with laboratory automation and IT.
The system "will fundamentally change the field of clinical diagnostics,” Roche Diagnostics CEO Matt Sause said in a 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."