MSACL notions on the evolution and future of clinical mass spectrometry

Mass spectrometry (MS) has been at the forefront of technological advancements in clinical diagnostics, with recent innovations making it increasingly accessible and efficient for laboratory use. Over the past decade, its adoption has grown significantly, driven by improvements in automation, regulatory changes, and enhanced integration into clinical workflows.

Leading experts in the field provide valuable insights into the evolution, challenges, and future of mass spectrometry in clinical diagnostics.

The growing role of clinical mass spectrometry

The adoption of mass spectrometry in clinical settings has expanded dramatically in recent years. According to Dr. Timothy Collier, Scientific Director of Research & Development for the Quest Cardiometabolic Center of Excellence at Cleveland HeartLab, "Mass spectrometry is being increasingly utilized in clinical diagnostic environments across the world as the technology and the ability to integrate with laboratory management systems and workflows improves." The financial aspect has also played a crucial role in its widespread adoption. "Efforts to increase the throughput of mass spectrometry-based systems have driven increased adoption of the technology, making the financial case more attractive," he adds.

Dr. Deborah French, Director of Chemistry and the Director of Mass Spectrometry at the University of California San Francisco Health Clinical Laboratories, echoes a similar sentiment, "The realization of the superiority of mass spectrometry for making sensitive and specific measurements of, for example, the steroid hormones, over immunoassay techniques for some patient populations was one of the reasons for the increased adoption of this technology." Additionally, the rise of novel psychoactive substances, for which no other measurement methods existed, created a demand for targeted assays developed via mass spectrometry.

Dr. Gwen McMillin, Professor (Clinical) at the University of Utah in the Department of Pathology and Medical Director for Clinical Toxicology, Mass Spectrometry and Pharmacogenomics at ARUP Laboratories, notes that mass spectrometry has become, "the dominant tool used in chemistry and toxicology applications, due largely to the specificity and multiplexing capabilities of the analytical approach." She estimates that in the past decade, "the number of mass spectrometry systems at ARUP has increased by fivefold," reflecting a broader trend in the medical community.

Automation in mass spectrometry workflows

The integration of automation in mass spectrometry has been transformative, significantly enhancing efficiency and throughput. "Automation, when deployed properly, can dramatically enhance the efficiency and throughput of workflows involving mass spectrometry," says Dr. Collier. "The ability to perform highly repetitive tasks without tiring also improves quality of results obtained by the mass spectrometer."

Dr. French highlights another crucial benefit of automation: reducing the burden on lab personnel. "Automated sample handling and sample preparation techniques can reduce the number of technologists required to implement a mass spectrometry testing service," she explains. Automation also plays a critical role in data analysis, as software solutions can now flag samples that do not meet pre-determined criteria, allowing technologists to focus on those requiring attention.

Dr. Daniel Holmes, Department Head and Medical Director of Pathology and Laboratory Medicine at St. Paul's Hospital, and Clinical Professor of Pathology and Laboratory Medicine at the University of British Columbia, offers a pragmatic view, stressing that automation is essential for scaling mass spectrometry in clinical settings. "These complex workflows scale poorly without the use of automation, and even with its use, we are often limited by the capabilities of robotic liquid handlers," he explains. He contrasts this with fully automated solutions which, "facilitate random access testing in the context of 24/7 service and does not require the user to have specialized skills in instrumental analysis."

Dr. McMillin emphasizes that, "automation is critical for generating consistent, high-quality results for most clinical mass spectrometry tests, particularly when multiple instruments and staff members are involved." She also notes that automation spans various stages of mass spectrometry workflows, including sample management, batch planning, liquid handling, data processing, and interpretive algorithms.

How to integrate mass spectrometry into routine clinical practice

Despite its many benefits, mass spectrometry still faces significant hurdles in becoming a standard tool in routine clinical diagnostics. One of the biggest challenges, according to Dr. Collier, is the level of expertise required to operate and maintain mass spectrometry systems. "Most assays utilizing mass spectrometry also lack FDA approval or clearance and are developed as laboratory developed tests (LDTs), which require labor-intensive validation procedures," he states.

Dr. French highlights the complexity of the technique itself. "This takes a significant amount of knowledge and time and is something most clinical laboratories do not possess." Furthermore, she points out that technical support can be a challenge. "If you have a problem with one of your assays, you cannot just call the service engineer to fix it. The impetus is on the lab to determine the issue and fix it."

Dr. Holmes expands on this, explaining that smaller labs struggle with the commitment required. "Traditionally, moving assays to mass spectrometry represented a significant commitment. The lab itself had to take care of all aspects of R&D, production, and supply chain to keep their assay available and performant," he says.

Dr. McMillin identifies other major challenges, including, "finding and retaining skilled scientists and operators, capital costs, appropriate site preparation, software mastery, and instrument maintenance." She adds that designing and maintaining robust methods and ensuring instrument-to-instrument parity are also significant concerns.

The future of clinical mass spectrometry

Looking ahead, experts foresee an even greater role for mass spectrometry in clinical settings. "I believe adoption of mass spectrometry in clinical diagnostics will continue to accelerate," says Dr. Collier. "More companies are developing end-to-end automated systems incorporating mass spectrometers that will enable the technology to be utilized as easily as other routine chemistry analyzers."

Dr. French suggests that with, "the advent of FDA-approved mass spectrometry solutions, it seems that more labs can implement this technology for commonly measured analytes." This regulatory shift could make mass spectrometry more accessible to a broader range of clinical laboratories.

Dr. Holmes anticipates that, "medium-sized hospital laboratories who bear a large burden for send-out testing to reference labs," will be among the first to adopt automated mass spectrometry solutions. He also expects increased discussion around, "machine learning and artificial intelligence applications to pathology and laboratory medicine."

Dr. McMillin envisions a future with, "fully-automated analyzers that utilize mass spectrometry, dramatically simplifying opportunities for implementation of mass spectrometry for routine testing in hospitals and clinics." She also sees potential in portable mass spectrometers for use in emergency departments and even hand-held mass spectrometry devices for field applications.

How MSACL is advancing mass spectrometry

The Mass Spectrometry Applications to the Clinical Laboratory (MSACL) organization plays a crucial role in advancing the field. "MSACL provides a forum for the convergence of experts in academia, hospital labs, commercial labs, and instrument vendors to share their development work and forge new collaborations," explains Dr. Collier.

Dr. French highlights the organization's inclusivity, stating that, "MSACL gives all of our colleagues the opportunity to present their work, whether it is participants from academic institutions presenting in a scientific session, researchers showcasing their findings of new biomarkers or drug targets, or vendor colleagues showcasing their new technologies in the exhibit hall."

Dr. Holmes points out that MSACL has historically been at the forefront of identifying impactful technologies. "MSACL as an organization is careful to have its eye on technologies capable of impacting clinical care and highlighting translational uses well ahead of routine availability."

Key topics at the 2025 MSACL conference

With the rapid advancements in mass spectrometry technology, this year’s MSACL conference is expected to feature several key discussions. Dr. Collier anticipates "translational research and the ever-changing regulatory environment" to be central themes. "The role the FDA will play in the regulation of LDTs has also been a perennial topic of discussion and will certainly be again this year," he adds.

Dr. French expects discussions on "ways to comply with the FDA final rule on laboratory developed tests" as well as the "release of a fully automated mass spectrometry solution for clinical laboratories." Dr. McMillin predicts that "the Roche Cobas i601 system will be a very hot topic," given its recent CE mark approval and upcoming European launch.

A look to the future

Mass spectrometry has made remarkable strides in clinical diagnostics, but challenges remain in integration, automation, and regulatory compliance. As automation improves and more FDA-approved solutions become available, the field is poised for broader adoption. The insights shared by leading experts illustrate an exciting future for mass spectrometry, with the MSACL conference continuing to play a pivotal role in its advancement.