Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. X:X | DOI: 10.5507/bp.2026.030

Translating microRNAs into clinical laboratory medicine: A critical review of biomarker potential, methodological barriers and implementation pathways

David Stejskal^{1, 2, 3}, Zdenek Svagera^{1, 2, 3}, Marek Buzga^{1, 2, 3}, Pavlina Kusnierova^{1, 2, 3}, Radka Sigutova^{1, 2, 3}

¹ Institute of Laboratory Medicine, University Hospital Ostrava, Ostrava, Czech Republic

² Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic

³ Lab4Life Ostrava FNOU, Ostrava, Czech Republic

This critical translational review evaluates the clinical significance of circulating microRNAs (miRNAs) across a broad spectrum of medical disciplines, identifies the main barriers to routine laboratory implementation and proposes a practical roadmap toward clinical use. A structured literature search of PubMed, Web of Science and Scopus covered English-language publications through May 2026. Evidence on preanalytical factors, analytical platforms, absolute quantification, reference interval derivation, clinical validation and translational feasibility of miRNA diagnostics was reviewed across oncology, neurodegeneration, cardiovascular disease, atherosclerosis, ophthalmology, acute kidney injury, sepsis, metabolic disease, liver disease, autoimmune disease, infectious disease, transplantation, reproductive medicine and toxicology. In multiple clinical domains, miRNAs may reflect pathophysiological processes earlier than established laboratory biomarkers; however, single miRNAs rarely offer disease-specific information. Multimarker panels combined with established biochemical markers demonstrate superior diagnostic and prognostic performance, whereas preanalytical standardization, absolute quantification and prospective clinical validation remain critical unmet needs. Reference intervals for eight cardiovascularly relevant miRNAs, determined in whole blood by the miREIA immunoassay, provide a first step toward routine implementation. Routine implementation of miRNA diagnostics therefore requires a five-stage laboratory medicine framework: preanalytical standardization, analytical validation with absolute quantification, biological reference data, prospective clinical validation and demonstration of clinical and economic utility beyond existing biomarkers.

Keywords: microRNA, biomarker, laboratory medicine, absolute quantification, reference intervals, standardization

Received: July 1, 2026; Revised: October 12, 2026; Accepted: October 14, 2026; Prepublished online: October 29, 2026