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May 4, 2026
CLSI EP49: Supporting Consistent Clinical Performance Evaluation Across Global Regulatory Environments
The medical laboratory community continues to evolve rapidly, driven by advances in technology, diagnostics, and everyday laboratory practice. But in 2026, progress is not defined by innovation alone. It also depends on how effectively test developers (both commercial manufacturers and laboratories developing tests) generate and apply evidence to meet increasingly rigorous and region-specific expectations of test methods for clinical performance.
The medical laboratory community continues to evolve rapidly, driven by advances in technology, diagnostics, and everyday laboratory practice. But in 2026, progress is not defined by innovation alone. It also depends on how effectively test developers (both commercial manufacturers and laboratories developing tests) generate and apply evidence to meet increasingly rigorous and region-specific expectations of test methods for clinical performance.
Across regulatory environments in Europe, US (and beyond, expectations are converging around a common principle: clinical performance must support user needs through, well-designed studies, and evidence aligned with intended use. This requires a comprehensive, structured, and harmonized approach to clinical performance studies.
Addressing a Global Gap in Clinical Performance Evaluation Guidance
Until now, guidance for establishing evidence of a test method’s clinical validity has been distributed across multiple sources, making it difficult for developers to identify a singular source of guidance to support meeting regulatory expectations. This challenge can create variability in how clinical validation is designed, how clinical performance is measured, and how study outcomes are interpreted.
CLSI EP49 | Framework for Developing Evidence of Clinical Validity of Medical Laboratory Test Methods was developed to address this challenge, bringing together recommendations, best practices, and expert consensus from global contributors into a single, unified framework. By framing a test method’s clinical performance in relation to its scientific and analytical validity, CLSI EP49 provides laboratories with a more consistent and defensible approach that is adaptable across regions and regulatory expectations.
"On a global scale, CLSI EP49 brings guidance that has traditionally been scattered across multiple sources into one cohesive framework," said Michelle Campbell MS, MLS(ASCP)CM, MBCM, SCCM, CLSI Volunteer and Senior Principal Developer for the Department of Laboratory Medicine at Mayo Clinic. "The result is a framework that is broadly applicable across test methods for users across the world."
Presenting a Structured Approach to Clinical Validity
Whether test developers in a commercial setting or in the medical laboratory, CLSI EP49 provides a structured framework for establishing evidence of clinical validity, an area that has historically lacked consistent, method-neutral guidance.
The guideline focuses on comparing a candidate test method with an appropriate comparator, helping ensure that results are interpreted in the context of the test's intended use. It also outlines key considerations for study design, data collection, and performance evaluation, supporting more reliable and reproducible outcomes.
The guideline emphasizes:
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Comparison of candidate test methods with appropriate comparators for assessing a target condition
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Clear alignment between study design and intended use
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Systematic evaluation of clinical performance data
By bringing these elements together, CLSI EP49 enables laboratories to move beyond isolated validation steps and offers a more comprehensive and harmonized approach supporting more reliable and reproducible evaluations of clinical performance.
In a global laboratory environment where consistency and reliability are essential for patient safety and clinical decision-making, CLSI EP49 represents an important step toward greater alignment in practices to evaluate clinical performance. CLSI EP49 helps test developers strengthen their approach to evaluating clinical validity, supporting robust evidence generation, clearer interpretation, and more confident application of test results worldwide.