Roche has received CE mark approval for its cobas Mass Spec solution comprising the cobas i 601 analyser and the Ionify reagent pack of four assays for steroid hormones.
The cobas i 601 analyser is a fully automated, integrated, and standardised end-to-end solution that brings clinical mass spectrometry to routine testing laboratories.
It offers more than 60 assays for testing steroids, vitamin D metabolites, immunosuppressant drugs (ISD), therapeutic drug monitoring (TDM) and drugs of abuse testing (DAT).
The Swiss health technology company said the CE mark approval paves the way for the commercial launch of its cobas Mass Spec solution worldwide.
Roche Diagnostics CEO Matt Sause said: “The cobas Mass Spec solution will fundamentally change the field of clinical diagnostics.
“The solution would make fully standardised 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.”
According to the company, high specificity, sensitivity and accuracy in mass spectrometry is considered the diagnostic ‘gold standard’ for various clinical conditions.
The high specificity of testing could provide more clarity to physicians, allowing them to make more timely treatment decisions for patients.
However, only specialist laboratories have been offering mass spectrometry until now, due to low automation, integration and standardisation and the high complexity of the workflows.
Roche said its new unique testing technology enables commercial automation with a workflow that is much more environmentally sustainable than the current method.
The cobas i 601 analyser, a part of the company’s cobas pro integrated solutions, features a consistent design and user-friendly interface, which reduces the need for staff training.
Also, the cobas pro integrated solutions enable full integration of the device into clinical chemistry and immunochemistry testing, along with lab automation and IT, said Roche.
