Roadblocks of urinary EV biomarkers : moving toward the clinic

Droste, Marvin (avtor), Lenassi, Metka (avtor), Erdbrügger, Uta (avtor)

Despite remarkable interest in the biomarker potential of urinary extracellular vesicles (uEVs) and the identification of numerous promising candidates, their clinical translation still presents multiple challenges. The opportunities for successful translation are obvious, yet the main roadblocks on the way have hardly been systematically considered and more coordinated approaches are needed to overcome them. In the present review article, we have identified the most relevant roadblocks of clinical translation of urinary EV-based biomarkers and discuss possible solutions to overcome them. These roadblocks are categorized as fundamental and technical but also related to development of novel biomarker assays and clinical acceptance. In addition, hurdles within the regulatory approval process are discussed. It is clear that various roadblocks to clinical translation of urinary EV biomarkers exist; however, they are addressable by promoting rigor and reproducibility as well as collaboration between basic and clinical scientists, clinicians, industry and regulatory bodies. Moreover, knowledge of obstacles for assay development and regulatory requirements should already be considered when developing a new biomarker to maximize the chance of successful translation. This review presents not only a status quo, but also a roadmap for the further development of the field.

• Jezik: Angleški jezik
• Ključne besede: biomarkers, bladder, exosomes, extracellular vesicles, kidney, liquid biopsy, prostate, translation, urine
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.02 - Pregledni znanstveni članek
• Organizacija: MF - Medicinska fakulteta
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2025
• Št. strani: 19 str.
• Številčenje: Vol. 14, iss. 7, art. e70120
• PID: 20.500.12556/RUL-182502
• UDK: 616.6
• ISSN pri članku: 2001-3078
• DOI: 10.1002/jev2.70120
• COBISS.SI-ID: 245710595
• Datum objave v RUL: 14.05.2026

Gradivo je del revije

• Naslov: Journal of extracellular vesicles
• Založnik: Wiley & Sons
• ISSN: 2001-3078
• COBISS.SI-ID: 9796948

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: biološki označevalci, mehur, eksosomi, zunajcelični vezikli, ledvica, tekoča biopsija, prostata, translacija, urin