Roche is innovating diagnostics by helping to create resilient, future-equipped clinical labs that can do more with less, ultimately helping clinicians make decisions so people live better, longer and healthier lives.
Only by reshaping healthcare today with sustainable, accessible and cost-efficient solutions will we be able to tackle the health challenges of tomorrow.
Mass spectrometry is a versatile and advantageous diagnostic tool found in a clinical lab. It can be used for certain clinical situations, such as measuring steroid hormones in endocrinology, vitamin D testing, and the monitoring of immunosuppressants and therapeutic drugs. The high specificity and sensitivity of testing can provide greater levels of clarity to physicians, which in turn can benefit patients through more precise and accurate results.
Mass spectrometry is considered a gold standard in certain clinical situations,1 but many labs are not able to use it because current solutions are too complex, lack integration and standardisation, and require highly trained personnel. Until now, no fully automated and standardised solutions have been available.
Roche has developed new technology in partnership with our long-term partner, Hitachi High-Tech, that automates, integrates and standardises mass spectrometry, making it possible to bring this powerful testing technique to the routine laboratory.
The technology combines sample preparation, separation, mass spectrometry analysis and result interpretation into one streamlined workflow. This automation can bring fast, accurate and precise analysis, boosting productivity and increasing efficiencies.
Automation makes possible the highest throughput in the in vitro diagnostics market, increasing the speed of sample processing and delivery of results. By optimising the workflow and transitioning away from batch processing, laboratories can eliminate the waiting time associated with collecting samples. Fast and easy handling frees up time for laboratory staff, addresses staffing shortages and reduces the risk of human error. Highly skilled staff can focus on more value-added tasks. Operators have minimal contact with biohazardous materials to ensure their health and safety.
An integrated solution is one that adapts to a lab’s specific needs and seamlessly connects into the broader lab infrastructure. Roche’s technology maximises performance and supports labs by combining technologies such as clinical chemistry, immunochemistry testing, ion-selected electrodes and mass spectrometry, to enhance the lab’s overall diagnostic capabilities.
Labs are often faced with numerous instrument configurations, as well as varying pre-analytic and analytical methods, data acquisition conditions, calibration and quality control concepts, and methods to interpret results, making it very difficult to compare results between labs and even between instruments.2-3 Roche’s technology improves standardisation, as every test is traceable to a reference method. This enables the consistency of results, any time and everywhere.
By improving efficiency and streamlining operations, mass spectrometry is no longer exclusively in the domain of specialised labs and can become more accessible to more labs across the globe, enabling better patient management wherever it’s needed.
Roche’s technology has the potential to impact the lives of countless people around the world. By reducing the waiting time from sample to result, it could help doctors diagnose conditions more quickly, ensuring faster intervention to help improve patient care.
More right-first-time results can lead to less follow-up testing, shorter periods of uncertainty and earlier detection. The faster patients are able to receive therapeutic intervention, the better their prognosis and recovery.
Increasing access to mass spectrometry also means more people will get accurate and faster decision support, which ultimately plays a role in strengthening our healthcare systems.
The fuller picture of a patient’s hormones provided by mass spectrometry is crucial to understanding and personalising treatment for specific cancers, such as breast and prostate.
Mass spectrometry can precisely distinguish between different types of vitamin D and supports the identification of functional vitamin D deficiency and personalised assessment of vitamin D status. Especially for particular patient populations, such as pregnant women, newborns, kidney patients or those in critical care, this is important information for personalising treatment.
PCOS is notoriously difficult to diagnose, and an estimated 70% of the millions of women worldwide with PCOS don’t even know what’s causing their often painful, disruptive and distressing symptoms.4 A quick and reliable diagnosis with mass spectrometry could empower them to take control of their health and well-being, even with a condition that currently lacks sufficient treatment options.5
Traditional immunoassays in paediatrics can make it more difficult to distinguish levels of certain hormones like estradiol and testosterone. Determining quickly what’s happening in a child's body can mean better outcomes, sooner.
For 5-10% of people with hypertension, the underlying cause is the under-recognised hormonal imbalance known as primary aldosteronism.6 While previously considered rare, emerging research has shown that PA affects 5% to 13% of people with hypertension and up to 30% of those with resistant hypertension.7 Aldosterone is found in such small concentrations that it’s very hard to measure. Early detection and diagnosis means no time is wasted trying out several different blood pressure-lowering drugs that don’t work and significantly lowering the risk of vascular events.
Organ transplants save lives. However, patients need to take immunosuppressive drugs after the operation so that the immune system doesn’t recognise the transplant as foreign tissue and try to reject it. Mass spectrometry is the most precise method of measuring immunosuppressants in patients’ blood in order to determine the exact dosage for the best response.
This highly prevalent disease can be successfully treated with the antimicrobial treatment linezolid, though it is very difficult to achieve the right dosage for patients, The clear and precise therapeutic drug monitoring (TDM) results enabled by mass spectrometry reveal if an efficient dose was reached and whether or not adjustments need to be made. Not only does this decrease the risk of drug-related adverse events for the patient, but it also helps limit the emergence of gram-positive drug-resistant bacteria.
TDM can be performed using mass spectrometry to find the right dosage. Finding the right dosage for antibiotics, especially in critically ill patients, is challenging; overdosing could lead to toxicity, but underdosing can be equally problematic. Approximately 40–60% of critically ill patients do not attain target concentrations,9 which means lower rates of clinical cure and bacteriological eradication. TDM is increasingly used to avoid underdosing and is one pillar of antibiotic stewardship that can support our fight against antimicrobial resistance.
Learn more about mass spectrometry and the Roche innovations that open up its benefits to more clinicians and patients around the world.
References
Rankin-Turner S. and Heaney L. (2023). CCLM 61, 873-879. Available from:
Vogeser, et al. A proposal to standardise the description of LCMS-based measurement methods in laboratory medicine. Clin. Mass Spectrom. 2019;13:36-38
Seger, et al. Establishing metrological traceability in laboratory medicine. Clin Chem Lab Med. 2023; doi: 10.1515/cclm-2022-0995
World Health Organization [Internet; cited 2023 June 28]. Available from:
The Journal of Clinical Endocrinology & Metabolism [Internet; cited 2016 December 1]. Available from:
Clinical Chemistry [Internet; cited 2015 August 1]. Available from:
Yozamp N, Vaidya A. The Prevalence of Primary Aldosteronism and Evolving Approaches for Treatment. Curr Opin Endocr Metab Res. 2019 Oct;8:30-39. Doi: 10.1016/j.coemr.2019.07.001. Epub 2019 Jul 9. PMID: 32832727; PMCID: PMC7442120.Mulatero P, Monticone S, Deinum J, et al. Genetics, prevalence, screening and confirmation of primary aldosteronism: a position statement and consensus of the working group on endocrine hypertension of the European society of hypertension. J Hypertens. 2020;38(10):1919-1928.
Rao, G. G., R. Konicki, D. Cattaneo, J. W. Alffenaar, D. J. E. Marriott, M. Neely and I. A. S. Committee (2020)."Therapeutic Drug Monitoring Can Improve Linezolid Dosing Regimens in Current Clinical Practice: A Review of Linezolid Pharmacokinetics and Pharmacodynamics." Ther Drug Monit 42(1): 83-92.
Abdul-Aziz, M. H., J. C. Alffenaar, M. Bassetti, H. Bracht, G. Dimopoulos, D. Marriott, M. N. Neely, J. A. Paiva, F. Pea, F. Sjovall, J. F. Timsit, A. A. Udy, S. G. Wicha, M. Zeitlinger, J. J. De Waele, J. A. Roberts, M. Infection Section of European Society of Intensive Care, Pharmacokinetic/pharmacodynamic, M. Critically Ill Patient Study Groups of European Society of Clinical, D. Infectious, M. Infectious Diseases Group of International Association of Therapeutic Drug, T. Clinical, I. C. U. Infections in the and C. Sepsis Working Group of International Society of Antimicrobial (2020). "Antimicrobial therapeutic drug monitoring in critically ill adult patients: a Position Paper." Intensive Care Med.Mabilat C. Eur J Clin Microbiol Infect Dis. 2020;39:791–97
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