Roche has begun rolling out a new diagnostics system that aims to bring the gold-standard accuracy of mass spectrometry to the everyday clinical lab.
The company received a CE Mark approval in Europe for its cobas i 601 automated analyzer, plus a reagent pack of four assays for tracking steroid hormone levels, dubbed Ionify, in what it described as the first steps of a planned global launch.
Roche also said it will work to expand its menu of IVDR-compliant testing options to cover more than 60 analytes—including vitamin D metabolites, as well as immunosuppressant or other therapeutic medications, in addition to screens for illicit drugs.
“The cobas Mass Spec solution will fundamentally change the field of clinical diagnostics,” Roche Diagnostics CEO Matt Sause said in a statement. “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,” Sause added. Mass spectrometry can also help monitor the responsible use of antibiotics, with high sensitivity and specificity.
According to Roche, the system required the development of a new, proprietary chemistry to make an automated mass spectrometry workflow viable for routine commercial use. Previously, the approach was the domain of specialist labs due to its hands-on complexity and longer turnaround times.