Strategy for development of clinically useful glyco-biomarkers.

Recent advancements in proteomics technology have stimulated the widespread research and development in the area of biomarker discovery using mass spectrometry (MS). The final goal of biomarker discovery and development is to establish clinically useful and reliable diagnostic methods for various diseases. Specific alterations in the nature and composition of glycans attached to proteins are seen during the development and progression of a number of diseases and disorders. Therefore, development of glyco-biomarkers, which detect disease-specific glycoproteins and changes in glycoforms, is gaining much attention. The combined use of multiple technologies, not solely MS, is the key to the discovery of clinically significant and reliable biomarkers. We have employed the combination of quantitative real-time polymerase chain reaction (PCR), lectin microarray, liquid chromatography/mass spectrometry-based technique with isotope-coded glycosylation site-specific tagging (IGOT-LC/MS), and bioinformatics to successfully develop a novel diagnostic kit for the quantitative evaluation of liver fibrosis. Efforts to develop highly effective glyco-biomarkers for other diseases are also currently underway.