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THE PHARMA REVIEW (SEPTEMBER 2009)

Molecular Biomarkers: Easing the Diagnostic Process

Suraj Ramanathan

A molecular biomarker can be defined as an indicator of a particular disease state within an organism. They are primarily used in the diagnosis of a vast array of medical complications ranging from cancer to arthritis. Apart from this, biomarkers (also known as bio-signatures) are also functional as molecular indicators in the identification of environmental exposures of compounds or microorganisms for epidemiological studies and for environmental disasters such as oil spills. Over the turn of the century, the usage of molecular biomarkers for diagnostic applications has seemingly tripled, thanks to the introduction of novel assay systems and automated platforms which contribute to faster and accurate results. Improvements in technology and analytical clarity have allowed users to generate data in real-time, accelerating decision making and improving productivity.
 
A Brief Overview
Initially biomarkers were applied in the identification of blood glucose and cholesterol levels for the diagnosis of diabetes and cardiovascular complications. The introduction of micro-arrays in the mid 90’s revolutionised the way diagnosis was carried out paving opportunities for automated platforms. The integration of technologies such as proteomics, metabolomics and genomics has allowed researchers to capture the molecular fingerprints of specific diseases and classify them based on the genetic and molecular defects they harbor. The current areas which are showing increasing interests with respect to diagnosis applying molecular biomarkers include cancer, neurodegenerative diseases such as Alzheimer’s and several immunological complications.
 
Current Applications of Biomarkers
The development of biomarkers is primarily controlled by the increasing opportunity to replace traditional diagnostic assays with biomarkers and the introduction of powerful automated analysers. With respect to chemoprevention, Biomarkers help in identifying key regulatory molecules which could in turn be used as potential drug targets. Their presence could predict responses to mechanism based interventions and help researchers in evaluating candidate agents during pre-clinical drug development and also monitor subjects during clinical trials. An individual’s biological profile of existent molecular biomarkers can aid in the assessment of which drug to give along with its dosage. This would greatly reduce the drug development and clinical trial costs reducing the need for a large clinical trial population for drug approval.

 

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