The discovery of protein biomarkers that reflect the biological state of the body is of vital importance to disease management. Urine is an ideal source of biomarkers that provides a non-invasive approach to diagnosis, prognosis and prediction of diseases. Consequently, the study of the human urinary proteome has increased dramatically over the last 10 years, with many studies being published. This review focuses on urinary protein biomarkers that have shown potential, in initial studies, for diseases affecting the urogenital tract, specifically chronic kidney disease and prostate cancer, as well as other non-urogenital pathologies such as breast cancer, diabetes, atherosclerosis and osteoarthritis. PubMed was searched for peer-reviewed literature on the subject, published in the last 10 years. The keywords used were “urine, biomarker, protein, and/or prostate cancer/breast cancer/chronic kidney disease/diabetes/atherosclerosis/osteoarthritis”. Original studies on the subject, as well as a small number of reviews, were analysed including the strengths and weaknesses, and we summarized the performance of biomarkers that demonstrated potential. One of the biggest challenges found is that biomarkers are often shared by several pathologies so are not specific to one disease. Therefore, the trend is shifting towards implementing a panel of biomarkers, which may increase specificity. Although there have been many advances in urinary proteomics, these have not resulted in similar advancements in clinical practice due to high costs and the lack of large data sets. In order to translate these potential biomarkers to clinical practice, vigorous validation is needed, with input from industry or large collaborative studies.

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Cardiovascular disease (CVD) is the leading noncommunicable disease and main cause of death worldwide. Traditionally, blood has been the sample of choice for biomarker discovery, however, urine has roused great interest in recent years as a source of biomarkers. Sample collection is simple, non-invasive, and there is the possibility of implementing minimal cost tests in primary care settings. Areas covered: In this review, we systematically searched PubMed for proteomic studies of CVD, with the criteria that urine was included as a biological sample. Based on these criteria, and after manual curation, 47 research papers were included: 8 for coronary artery disease, 5 for angina, 15 for myocardial infarction, 23 for heart failure, and 4 for cerebrovascular disease. Expert commentary: Urinary biomarkers of early, asymptomatic stages of the disease would have a great impact on CVD morbidity and mortality, as widespread screening could be implemented at a reduced cost, allowing high-risk individuals to be identified and treated in a timely manner. An approach involving multiple biomarkers is necessary, as a single biomarker is unlikely to be sensitive/specific enough. By assessing a range of peptides there is the potential to detect changes in many pathways involved in the pathogenesis of CVDs.