A2 Refereed review article in a scientific journal
Roadblocks of Urinary EV Biomarkers: Moving Toward the Clinic
Authors: Droste, Marvin; Puhka, Maija; van Royen, Martin E.; Ng, Monica S. Y.; Blijdorp, Charles; Alvarez-Llamas, Gloria; Borràs, Francesc E.; Buescher, Anja K.; Bussolati, Benedetta; Dear, James W.; Falcón-Pérez, Juan M.; Giebel, Bernd; Grange, Cristina; Hoorn, Ewout J.; Leivo, Janne; Lenassi, Metka; Llorente, Alicia; Lucien, Fabrice; Mertens, Inge; Mischak, Harald; Pink, Desmond; Tertel, Tobias; Tiwari, Swasti; Vizio, Dolores Di; Yuen, Peter S. T.; Zarovni, Natasa; Jenster, Guido; Burger, Dylan; Martens-Uzunova, Elena S.; Erdbrügger, Uta
Publisher: Wiley
Publishing place: HOBOKEN
Publication year: 2025
Journal: Journal of Extracellular Vesicles
Journal name in source: Journal of Extracellular Vesicles
Journal acronym: J EXTRACELL VESICLES
Article number: e70120
Volume: 14
Issue: 7
Number of pages: 19
ISSN: 2001-3078
eISSN: 2001-3078
DOI: https://doi.org/10.1002/jev2.70120
Web address : https://doi.org/10.1002/jev2.70120
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/499204976
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.
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Funding information in the publication:
Funding: This research was supported in part by ADA (American Diabetes Association) 722ICTSPM19, NIH (National Institute of Health) IR01DK133598-01A1(to U.E.), by the Intramural Research Program of the NIH, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (to P.S.T.Y.), by Instituto de Salud Carlos III with co-funding from the ERDF (PI20/01103, RD21/0005/0001), Comunidad de Madrid (PIPF-2022/SAL-GL-25760), FundaciónMutua Madrileña and Fundación SENEFRO (to G.A.L.), by the Slovenian Research and Innovation Agency (ARIS) research grant J3-50117 (to M.L.), by the Queensland Health Clinical Research Fellowship and Metro North Clinician Research Fellowship (to MSY.N.), by the Canadian Institutes of Health Research(186237), Natural Sciences and Engineering Research Council (2021-03424) and Kidney Foundation of Canada (920575) (to D.B.), by NIH/NCI Grants no.R01CA234557, R01CA287075 (to D.D.V.) and by the European Union (ERC, U-Tube, 101125504) (to E.H.). Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the European Research Council. Neither the European Union nor the granting authority can be held responsible for them.
