Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received CE mark approval for its cobas® Mass Spec solution including the cobas® i 601 analyser and the first Ionify® reagent pack of four assays for steroid hormones². The CE mark is the first milestone in the global launch of the cobas Mass Spec solution, using in-house innovation to bring automated, integrated and standardised clinical mass spectrometry testing to routine laboratories worldwide. Following launch, the cobas Mass Spec solution will roll out a menu offering of more than 60 analytes for testing of steroid hormones, vitamin D metabolites, immunosuppressant drugs (ISD), therapeutic drug monitoring (TDM) and drugs of abuse testing (DAT).

“The cobas Mass Spec solution will fundamentally change the field of clinical diagnostics,” said Matt Sause, CEO of Roche 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.”

The high specificity, sensitivity and accuracy of mass spectrometry is considered the diagnostic ‘gold standard’ for various clinical situations, for example measurements of steroid hormones in endocrinology, vitamin D testing, the monitoring of immunosuppressants and therapeutic drugs. Examples of how mass spectrometry can benefit healthcare systems include the effective and responsible use of antibiotics and ongoing monitoring of disease progression and treatment. The high specificity of testing can provide greater levels of clarity to physicians, enabling more timely treatment decisions for patients.

New, proprietary chemistry technology developed by Roche makes commercial automation possible, with a workflow that is much more environmentally sustainable than current methods. Until now, mass spectrometry has only been offered by specialist laboratories due to the low level of automation, integration and standardisation and the high complexity of the workflows that require highly skilled operators. This has resulted in great variability between different laboratories and long processing times.

The cobas Mass Spec solution will be part of Roche’s established cobas® pro integrated solutions which allows for full integration into clinical chemistry and immunochemistry testing as well as lab automation and IT.