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Swiss biotechnology firm Roche has announced that its cobas® Mass Spec solution, which includes the cobas® i 601 analyzer and the first Ionify® reagent pack of four assays for steroid hormones, has been approved with the CE mark.

The CE mark signifies that this product sold in the European Economic Area has been assessed to meet high safety, health, and environmental protection requirements.

Using internal innovation, the CE certification marks the first milestone in the global rollout of the Cobas Mass Spec system, which brings automated, integrated, and standardized clinical mass spectrometry testing to routine laboratories across the globe.

After its launch, the Cobas Mass Spec solution will expand its offering to include over 60 analytes for testing of immunosuppressive medications (ISD), steroid hormones, vitamin D metabolites, therapeutic drug monitoring (TDM), and drugs of abuse testing (DAT).

Mass spectrometry's high specificity, sensitivity, and accuracy make it the diagnostic "gold standard" for a variety of clinical scenarios, such as vitamin D testing, immunosuppressant monitoring, therapeutic medication monitoring, and endocrine steroid hormone measures.

The rational use of antibiotics and continuous monitoring of the course and management of disease are two instances of how mass spectrometry can help healthcare systems.

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Physicians now also have the possibility of making more informed judgments about patients' care more quickly thanks to the high specificity of testing.

"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."

Commercial automation is made possible by Roche's new, proprietary chemical technology, which has a workflow that is far more environmentally friendly than existing techniques.

Because of the great complexity of the workflows requiring highly competent operators and the low level of automation, integration, and standardization, mass spectrometry has only been available through specialized laboratories up to this point.

This has led to lengthy processing periods and significant variation within laboratories.

The Cobas Mass Spec solution will be a component of Roche's well-known Cobas® Pro integrated solutions, which enable complete integration with IT, lab automation, and clinical chemistry and immunochemistry testing.

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