Diagnostic Labs Get One Step Closer to Automated Clinical Mass Spectrometry
CE mark for the cobas® Mass Spec solution brings routine labs closer to automated clinical mass spectrometry.
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Roche has announced it has received a CE mark for the cobas® Mass Spec solution (including the cobas i 601 analyzer and the first Ionify® reagent pack for steroid hormones). The CE mark indicates that the product has been deemed to meet EU safety, health and environmental protection requirements. This is the first step in a global launch, which hopes to broaden access to fully automated clinical mass spectrometry for routine testing labs.
Clinical uses of mass spectrometry have historically been limited to specialist facilities due to complex workflows requiring highly skilled lab technicians. This new solution automates the entire workflow enabling routine testing laboratories to capitalize on the high sensitivity, specificity and accuracy of mass spectrometry testing.
Improved access to clinical mass spectrometry in routine labs will enable healthcare professionals to gain a more comprehensive understanding of complex clinical scenarios faster, leading to improved patient care.
Benefits of mass spectrometry in the clinical laboratory
There is a growing global burden of disease largely driven by chronic diseases such as diabetes and cancer plus an aging population. As a result, healthcare services are under increasing budget pressures, with diagnostic labs expected to manage increasing numbers of samples and deliver high medical value while improving cost efficiency.
The sensitivity and selectivity of mass spectrometry make it an ideal tool for clinical tests such as detecting steroid hormones, vitamin D testing and the monitoring of immunosuppressants and therapeutic drugs. In addition, mass spectrometry can add additional layers of information to traditional clinical chemistry and immunohistochemistry testing to address diverse patient cohorts.
What is mass spectrometry?
Mass spectrometry measures the mass-to-charge ratio (m/z) of atoms and/or molecules in a sample. These measurements can be used to determine the exact molecular weight of a sample’s components and to identify unknown compounds.
Despite its benefits, a lack of robustness in existing mass spectrometry instrumentation in the context of minimizing downtime and reducing the level of technical expertise required for its efficient operation has limited its use to dedicated mass spectrometry labs.
Towards automated, high-throughput diagnostics testing
Designed to overcome the unmet need for access to precision mass spectrometry testing in routine clinical practice, the cobas Mass Spec analyzer enables labs to automate and standardize repetitive high-throughput mass spectrometry testing. This fully automated solution is designed to free up resources in the lab, which can then be repurposed for higher-value tasks so that labs can receive more samples.
When asked about the training requirements for the instrument during a press conference, Dr. Peter Heiss, head of R&D for mass spec at Roche, said, “What the technician has to learn is a new instrument, of course, but it is not necessary to get trained in the technology of liquid chromatography and mass spectrometry,” adding that “training is comparable to the other instruments we have already within the routine lab.”
A key component of the solution is the incorporation of “super beads” developed by Roche scientists. These paramagnetic particles are part of the sample preparation stage of the workflow designed to separate the analytes of interest from the sample fluid.
The beads are porous with sponge-like entry channels that allow only the wanted molecules to enter. Roche scientists invented two types of beads – generic and specific. Generic polymer-coated beads catch multiple analytes. More precise beads are used to measure very low-concentration analytes, such as steroids and vitamin D. The invention of both bead types was vital to making automation commercially viable.
As an additional benefit, paramagnetic particle-based sample preparation requires only micrograms of reagents and thus produces much less plastic waste than comparable methods.
Applications in routine diagnostic labs
The cobas Mass Spec solution will launch with an in vitro diagnostic test menu of more than 60 assays that will be rolled out in 2 waves. Wave one will focus on panels for steroid hormones, vitamin D, immunosuppressant drugs and assays for therapeutic drug monitoring. Wave two will add additional parameters for vitamin D subclasses, therapeutic drug monitoring and the first panel in drugs of abuse testing.
Amsterdam University Medical Centre (UMC) was one of eight multicenter evaluation sites that tested the cobas Mass Spec solution in a real-world setting. During a press conference, Dr. Robert de Jonge, a full professor and head of the department of laboratory medicine at Amsterdam UMC, discussed how the cobas Mass Spec solution enables the lab to generate results for anti-epileptic drug samples in one to two hours. Anti-epileptic drug levels can change rapidly, so having access to 24/7 measurements can allow healthcare professionals to make rapid decisions on dosing to avoid overdoses.
“What is important for us is that we have a shortage of personal […] on the other hand we see increasing demands for lab testing. To meet demands, we need this kind of automation […] routine tests are more and more automated like vitamin D, steroid and drugs of abuse so we can now focus specialized lab testing on new innovations and new developments and more difficult assays to develop,” said Dr. Robert de Jonge.
An increase in access to routine precision mass spectrometry testing in clinical practice will not only benefit labs but also enable more patients to receive accurate and fast clinical support. The CE mark for the cobas Mass Spec solution is the first step in a global launch that will see the solution rolled out in 27 markets in the next few years.
