Biomarkers

What is Biomarkers?

Biomarkers may be defined as a characteristic that is objectively measured and evaluated as an indicator of any exposure, biological process or state of a biological system. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.

Biomarkers take part in a number of ways, including measuring the progress of the disease, evaluating the most effective therapeutic regimes for a particular cancer type, and establishing long-term susceptibility to cancer or its recurrence. In molecular terms biomarker is the subset of markers that might be discovered using genomics, proteomics technologies or imaging technologies.

Biomarker Analysis

A variety of assays are routinely used for studying biomarkers, including the following:

• Flow cytometry for cell functionality and phenotyping and biomarker expression
• Meso Scale Discovery Electrochemiluminescence (MSD-ECL) and ELISA-based cytokine and chemokine profiling
• Imaging-based rare cell analysis to track cells that express biomarkers of response
• Histology and digital pathology for biomarker detection and spatial expression
• Clinical chemistry for drug efficacy and mechanism of action (MOA) assessments
• Mass spectrometry-based proteomic analyses
• Genomic analyses

Incorporating genomics into the biomarker discovery and analysis workflow can accelerate drug development. Methods such as RNASeq, PCR, and next-generation sequencing (NGS) provide detailed genomic and transcriptomic insights on the complexity of the disease, tumor drug response, drug MOA, and novel biomarkers, such as gene mutations and changes in tumor gene expression, that correlate with drug response or resistance. These assays are amenable to high throughput approaches for large scale preclinical studies that require parallel evaluation of a large number of genomic biomarkers.

Fig. 1 Schema of omics technologies

Biomarkers play an important role in improving the drug development process as well as in larger biomedical research enterprise. Understanding the relationship between measurable biological processes and clinical outcomes is vital to expanding our arsenal of treatments for all diseases, and for deepening our understanding of normal, healthy physiology.