Dr. Benjamin Lilienfeld discusses Roche mass spectrometry solution launch
Roche Diagnostics leadership answers questions around cobas® mass spectrometry solution launch
8 Jan 2025
Dr. Benjamin Lilienfeld, Lifecycle Leader Serum Work Area Systems, Senior Vice President, Roche
Dr. Benjamin Lilienfeld, Lifecycle Leader Serum Work Area Systems, Senior Vice President, Roche tells SelectScience® more about the exciting launch of the cobas® Mass Spec solution for clinical diagnostic laboratories.
What is mass spectrometry?
Mass spectrometry is an analytical technology that measures the mass-to-charge ratio (m/z) of molecules in a sample, such as small organic compounds, proteins, and peptides. Historically, it was used as a common basic research tool, but over the last decade it increasingly gained adoption across many other applications including clinical diagnostics, drug discovery, environmental analysis, and forensic investigations.
Its high sensitivity, specificity, and accuracy makes it particularly advantageous for diagnostic testing in clinical settings. By combining the strengths of clinical mass spectrometry, clinical chemistry, and immunochemistry, healthcare professionals can gain a more comprehensive understanding of complex clinical scenarios, ultimately contributing to better patient care.
What is the cobas® Mass Spec solution?
The cobas® Mass Spec solution is a new in-vitro diagnostics solution utilizing mass spectrometry as a detection technology. It is a fully automated (sample preparation to result interpretation), integrated, and standardized clinical mass spectrometry solution with a broad test menu of more than 60 assays that will be rolled out over time. A total solution for all types of laboratories, it includes hardware, software, respective reagent kits, system reagents, and consumables. Until now, use of this technology in clinical settings has been limited to specialized laboratories.
By broadening access to clinical mass spectrometry testing in the near future, the cobas® Mass Spec solution could become a game-changer in the field of clinical diagnostics, enabling faster and better clinical decisions and, in turn, better patient care.
The cobas® Mass Spec solution
How is the cobas® Mass Spec solution different from current practice?
The cobas® Mass Spec solution is designed for routine testing, enabling seamless integration of mass spectrometry into existing serum work area testing (clinical chemistry and immunochemistry).
With the cobas® Mass Spec solution, samples that were previously exclusively tested in dedicated mass spectrometry laboratories or sent out to reference laboratories can now be analyzed in the routine laboratory. This is particularly helpful for special parameters that are not currently available through clinical chemistry or immunochemistry.
How can clinical laboratories benefit from the cobas® Mass Spec solution?
The cobas Mass Spec solution produces results in a much shorter turnaround time than current workflows. The entire workflow adds up to 100 results per hour, with a new sample analyzed every 36 seconds and the first result delivered in around 40 minutes.
It also helps laboratories already offering mass spectrometry testing automate and standardize high-throughput testing. This frees up staff time and resources for higher value tasks such as menu expansion, publications, and clinical research activities, thereby increasing their competitive edge. Meanwhile, laboratories not yet offering this testing can integrate this gold-standard technology into their services without the need for highly qualified specialists, thus expanding their offerings.
How will patients benefit from cobas® Mass Spec solution?
The cobas® Mass Spec solution enables better patient care by providing faster, more accurate, and standardized results, irrespective of the sample's location of analysis. Increased access to this precision testing in routine clinical practice enables accurate and speedy decision support, potentially strengthening healthcare systems significantly.
When will the cobas® Mass Spec solution be available?
The cobas® Mass Spec solution will be rolled out in 27 markets over the next few years.
CE marking enables Roche to sell the device in most European countries and in some markets outside Europe, such as New Zealand. More approvals are expected soon: Japan, Singapore, and Brazil likely by mid-2025, followed by countries including Saudi Arabia, the United Arab Emirates and some Asian countries.
In the US, the largest market for mass spec testing, the registration process is more complex. First tests, for example for vitamin D or steroid hormones, could be approved in the second half of 2025 under a category for less complex molecules. Full US approval is expected in 2026.
Together with the CE marking for the instrument, Roche can distribute an initial test for steroid hormones. During the course of 2025, the company plans to launch a total of 40 tests. Another more than 20 tests are expected to follow in a second wave several years later.