Roche Diagnostics has secured CLIA “moderate complexity” categorization for its Ionify mass spectrometry steroid assays – a designation the company says could help move advanced hormone testing beyond specialist and reference laboratories and into more routine clinical settings. The steroid menu includes estradiol, DHEA, DHEA-S, progesterone, 17-hydroxyprogesterone, and androstenedione, building on Roche’s earlier moderate-complexity designation for its mass spectrometry-based Vitamin D test.
To discuss what this milestone means for labs, clinicians, and patients – and whether clinical mass spectrometry is reaching a broader inflection point – we spoke with Allyson Kozak, Senior Scientific Affairs Manager for Mass Spectrometry and Women’s Health at Roche Diagnostics.
What are the main barriers preventing mass spectrometry's wider adoption in routine clinical settings?
For decades, mass spectrometry has served as a gold standard technology for diagnostic sensitivity and specificity. However, there have been real operational, technical, and financial challenges that have limited its use in routine clinical settings. Arguably, the number one challenge is complexity. Mass spec workflows tend to be very manual and multi-step. This creates room for human error and variability, even when highly trained specialists are at the helm.
These labor-intensive procedures – specifically manual sample preparation, tube labeling, and batch-specific instrument configuration – significantly impede throughput. Such inefficiencies are incompatible with the high-volume requirements and rapid turnaround times (TATs) essential for modern clinical laboratories to maintain a competitive advantage. Other concerns include the cost of the instruments (both the upfront purchase and maintenance/management) and the high degree of variability in results and interpretation between labs.
These are some of the major barriers that have limited the use of mass spectrometry outside of clinical referral and reference laboratories.
Roche has now secured CLIA “moderate complexity” status for mass spectrometry steroid assays. Could you explain what this designation means in practice for clinical laboratories?
Clinical laboratory test systems are assigned a moderate or high complexity category on the basis of seven criteria outlined in CLIA regulations. A “moderate complexity” designation signals that a test can be performed with structured quality controls and trained personnel, but without requiring the most stringent level of regulatory oversight. Securing this designation for our first Ionify steroid assays was a big milestone for us (and the industry), breaking through the barrier of high-complexity mass spectrometry and proving that the technology can be integrated into routine clinical laboratory workflows. It’s no longer just in the realm of highly specialized labs.
Were there particular technical or operational challenges in simplifying mass spectrometry workflows to this level, and how were they addressed?
The most significant technological breakthroughs are currently centered on the integration of end-to-end automation.The cobas Mass Spec solution is a fully automated unit, from sample preparation, separation, and detection, to validating the results, and finally transferring that data into the laboratory information system (LIS). Through intentional design focused on standardization and ease of operation, the system minimizes technical barriers and workflow errors.
How might expanding access to mass spectrometry-based hormone testing change clinical decision-making or patient care in practice?
Expanding access to mass spec-based hormone testing could significantly impact how conditions like endocrinology, oncology, and reproductive health are diagnosed, monitored, and/or treated. These are areas where the superior specificity and sensitivity of mass spectrometry can really make a difference, as small variations in hormone levels can influence diagnosis and treatment decisions. For that reason, a lot of these tests have historically been performed at specialized reference laboratories. However, as automation and standardization bring mass spectrometry into routine clinical labs, that dynamic begins to change. With access to new automated mass spectrometry solutions, clinicians can get faster, more reliable data to guide earlier detection of subtle hormonal changes or to interpret more complex cases. Overall, it’s a tool for more confident decision-making.
For patients, broader access to mass spec-based tests could potentially shorten their time to diagnosis and perhaps minimize the need for repeat testing. It also opens the door to more personalized care, as clinicians can track small changes in hormone levels over time and tailor the individual’s treatments accordingly.
Do you see this as a broader turning point for mass spectrometry in clinical diagnostics?
Absolutely. We are at an inflection point with the use of mass spectrometry in clinical laboratories, after many decades of applying this technology in higher complexity settings. Advances in automation, standardization, and integrated workflows are finally making it feasible to bring mass spectrometry into routine clinical settings, which unlocks all of the benefits listed above.
This shift has broader implications beyond hormone testing. It signals a move toward a new diagnostic paradigm where high-specificity, multi-analyte testing becomes more widely available and more actionable. This advancement is pivotal for integrating specialized diagnostics into the clinical workflow. By optimizing mass spectrometry for speed and reliability, it becomes a primary driver of real-time care coordination, rather than a secondary tool for retrospective verification.
Which other types of assays or applications could follow a similar path?
We plan to offer a broad menu of mass spectrometry assays in the US market. Our pipeline continues to grow with approximately 30 assays under development spanning steroids, vitamin D metabolites, therapeutic drug monitoring, and urine drug testing.
Looking ahead, what further developments are needed to make mass spectrometry a truly routine tool across clinical laboratories worldwide?
While democratizing mass spectrometry technology is a critical prerequisite, it must be supported by a robust infrastructure of inter-laboratory standardization. Regulatory pathways and results harmonization must evolve in tandem to ensure diagnostic accuracy remains consistent across decentralized testing environments.
The industry needs to continue to push for standardization across assays and platforms. This has historically been one of the drawbacks of mass spectrometry. While it offers exceptional precision, the variability in methods and calibration can make it difficult to compare results between labs. Robust standardization and protocol harmonization are necessary to bolster clinical confidence and ensure the diagnostic integrity of results, regardless of the processing facility.
Finally, we need to evolve regulatory pathways and reimbursement frameworks that align with the new role this technology can play in diagnostics. Clear guidance and appropriate reimbursement will help reduce barriers to adoption and ensure that the clinical value of mass spectrometry-based testing is recognized within healthcare systems.
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