Abstract

A clinical biomarker has been defined as “any cellular, biochemical, molecular, or genetic alterations by which a normal, abnormal, or simple biological process can be recognized or monitored” (Drucker and Krapfenbauer, 2003; Rahim et al., 2015). Biomarkers are widely employed throughout medicine on a day to day basis to diagnose, prognosticate, and predict outcomes of disease and illness or even as guides of treatment. They can either be used as a standalone, or more commonly, in conjunction with other test results. Moreover, biomarkers are often chosen as “surrogate endpoints” in clinical trials. Biomarkers must fulfill certain criteria in order to make it in to regular use in clinical practice. They must be specific to the condition that they are indicated in, sensitive, and must be practical in terms of accessibility of the sample, ease of testing method and provide information in which to guide clinical decisions. However, many biomarkers have unsatisfactory specificity or are not as sensitive as they are made out to be. In addition, biomarkers for some conditions are not yet available. Consequently, research in to novel biomarkers should be encouraged.

Highlights

  • Reviewed by: Alessio Paone, Sapienza University of Rome, Italy Vijay Kumar Prajapati, Central University of Rajasthan, India

  • Examples of intracellular biomarkers include many of those used in oncology, such as BRCA1/2 (Drooger et al, 2015), and estrogen receptor and hormone receptor status in breast cancers (Yang et al, 2014), and BRAF genes in melanoma (Dar et al, 2015)

  • But not yet conclusive, new area of research with the potential to derive new clinical biomarkers has been into microRNAs. These short RNA molecules were discovered in 1993 (Lee et al, 1993) in C. elegans and found present in human samples in 2000. Their love story with the biomedical community has seen a crescendo of enthusiasm and they have been highly regarded as both novel therapeutic targets, and possible intracellular and extracellular biomarkers

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Summary

Introduction

Reviewed by: Alessio Paone, Sapienza University of Rome, Italy Vijay Kumar Prajapati, Central University of Rajasthan, India. In a recent article reporting the results of the comparison among 15 previous reports on potential new breast cancer biomarkers (Leinder et al, 2013) there was a scarce overlap between results: “Of the 143 circulating miRNAs reported to be differently regulated, 100 were supported by just 1 reference; 25 others had discordant results across publications and of the remaining 18 miRs, 8 had fold changes too low to be confirmed.

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