Onkológia 3/2026

Biomarkers and the role of next-generation sequencing in modern oncology

Biomarkers are biological characteristics of tumour tissue that are important for diagnosis, prognosis and prediction of response to treatment, and whose detection is crucial for establishing the correct diagnosis, choosing the appropriate treatment and monitoring therapeutic response. This review summarises the importance of biomarkers in clinical oncology and highlights the growing role of NGS in personalised medicine. By analysing available knowledge on diagnostic, prognostic and predictive biomarkers, and selected data on the use of NGS in EU countries and the biomarker dependence of EMA-registered oncology indications in 2015–2024, we found that approximately 43% of EMA-registered oncology indications require confirmation of a predictive biomarker before starting treatment. NGS is most established in the diagnosis of lung, colorectal and breast cancers, while wider implementation is limited by differences in reimbursement and financing, and by a lack of local pharmacoeconomic data. Biomarker testing, including NGS, is crucial for proper patient stratification and treatment optimisation, but wider implementation requires standardised indication criteria and stable reimbursement mechanisms.

Keywords: biomarker, molecular diagnosis, high-throughput sequencing, NGS, precision medicine, ESCAT, ESMO