Biomarkers: hopes and challenges in the path from discovery to clinical practice

Abstract

Biomarkers are objectively measured indicators of normal or pathological processes that may be helpful in diagnosis, staging, monitoring treatment, or prognostic evaluation of a disease. Although development of genomic, metabolomic and proteomic technologies has contributed to an explosion in identification of candidate analytes, validation remains expensive and challenging, and successful introduction of new biomarkers to clinical practice occurs at a very slow pace. The goal of this introductory overview is to provide the context for a series of review manuscripts published in the special issue on biomarkers. The promises and challenges of biomarker discovery are highlighted. Discovery and implementation of transformative new biomarkers in clinical practice requires close collaborations between scientists, clinicians and industry. High throughput technologies can identify a myriad of promising candidates but cannot predict their clinical value. In addition to rapid effective and systematic approaches for clinical validation, there is a need to study and establish links between the purported biomarker and the pathophysiologic basis of the disease of interest. Biomarkers are most informative when they provide insights into activation of specific pathways, thus serving as windows into the molecular basis of the disease.

Pathophysiology of Myocardial Infarction

“…Optimal design of new therapies requires pathophysiologic insights and sound understanding of the complexities of the clinical context. In the future, biomarkers and imaging strategies may be used to identify subpopulations of patients with distinct pathophysiologic characteristics to implement personalized treatment strategies (111,113).…”

A triple-biomarker approach for the detection of delayed graft function after kidney transplantation using serum creatinine, cystatin C, and malondialdehyde

“…We focused particularly on improving the sensitivity and specificity in order to increase the accuracy of the diagnosis of acute graft dysfunction and of dialysis requirement prognosis. A very large number of biomarkers fail to be used in clinical practice due to the weakness of their clinical performance, namely, low sensitivity and low specificity [34]. The current study identified a simple and clinically applicable tool for detecting graft dysfunction earlier than SCr alone.…”

Comparative analysis of diagnostic significance of biomarkers’ panels in cardiac recipients in the long term period after transplantation

“…Однако сложность их применения на практике обус-лавливается неспецифичностью тестов и наличием большого числа факторов, влияющих на уровень этих показателей [7][8][9][10][11][12]. Использование панели из нескольких аналитов позволяет повысить чувс-твительность и специфичность мультимаркерных тестов [13,14].…”