Exosomes in Clinical Laboratory: From Biomarker Discovery to Diagnostic Implementation.

Exosomes, which are extracellular vesicles measuring 30-150 nm, are becoming a promising new target from cellular debris classification to a recognized biomarker with the potential to transform diagnostics. They have a fundamental role in intercellular communication, with selective molecular cargo that can reflect the pathophysiological state of parent cells. Exosomes are particularly advantageous for non-invasive liquid biopsies, as they provide continuous monitoring of disease progression or response to treatment. We detail the most recent diagnostic proteins, nucleic acids, and lipids in the context of different diseases. Here, we show the potential of exosomes as non-invasive biomarkers across diverse diseases, which may transcend the sensitivity of conventional biomarkers. The potential of exosome-based liquid biopsies to transform clinical laboratory practice will be determined by their ability to overcome challenges. Limitations comprise preanalytical variability, absence of standardized protocols, and heterogeneity in exosome isolation, which limit their diagnostic potential. The implementation is limited by isolation and analytical processes; however, many advanced platforms may offer multiplexed detection, which is accelerating their implementation process in clinical laboratories. Finally, we provide an overview of the clinical applications and preclinical advancements of exosomes to provide a perspective on the significance of exosomes for their use in biomarker study, as well as therapeutic monitoring in different diseases. Future initiatives must emphasize coordinated validation, economical scalability, and incorporation into clinical workflows to fulfill the potential of exosomes as advanced diagnostics.