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Biomarkers for renal cell carcinoma — a pragmatic approach

The management of metastatic renal cell carcinoma (RCC) has undergone a major transformation, with median survival increasing from <1 year to ~5 years. However, biomarker development in RCC has lagged, largely because the most effective therapies, such as immune checkpoint inhibitors and VEGFR tyrosine kinase inhibitors, act on the tumour microenvironment rather than directly on tumour cells. Although predictive biomarker development in RCC remains challenging, selected tools such as circulating biomarkers and tissue-based RNA signatures are shaping a personalized approach to care, with some emerging biomarkers showing clinical potential, and additional biomarkers poised to enter clinical practice.

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Acknowledgements

Z.B., A.A.H., E.R. and R.J.M. report support from the National Cancer Institute Cancer Center Core (grant P30-CA008748) supporting Memorial Sloan Kettering Cancer Center. Z.B. reports support from the National Cancer Institute’s Clinical Scholars Biomedical Research Training Program (grant T32CA009512-35).

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Correspondence to Robert J. Motzer.

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Z.B. reports honoraria from UpToDate. A.A.H. reports research funding from Merck. R.J.M. has provided consulting or advisory roles for Exelixis and Merck and has received research funding from Aveo, Bristol Myers Squibb, Eisai, Exelixis, Pfizer and Merck. E.R. declares no competing interests.

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Bakouny, Z., Hakimi, A.A., Reznik, E. et al. Biomarkers for renal cell carcinoma — a pragmatic approach. Nat Rev Urol (2025). https://doi.org/10.1038/s41585-025-01073-z

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