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Abstract
Many proteins in the living body are glycoproteins, which present glycans linked on their surface. Glycan structures reflect the degree of cell differentiation or canceration and are cell specific. These characteristics are advantageous in the development of various disease biomarkers. Glycoprotein-based biomarkers (glyco-biomarkers) are developed by utilizing the specific changes in the glycan structure on a glycoprotein secreted from the diseased cells of interest. Therefore, quantification of the altered glycan structures is the key to developing a new glyco-biomarker. Glycoscience is a relatively new area of molecular science, and recent advancement of glycotechnologies is remarkable. In the author’s institute, new glycoscience technologies have been designed to be efficiently utilized for the development of new diagnostic agents. This paper introduces a strategy for glyco-biomarker development, which was successfully applied in the development of Wisteria floribunda agglutinin-positive Mac-2 binding protein M2BPGi, a liver fibrosis marker now commercially available for clinical use.
Acknowledgements
The development of the base technologies involved more than 100 AIST members. Dr. Atsushi Kuno (biochemist, AIST) and Dr. Yuzuru Ikehara (pathologist, AIST) played pivotal role in the development of M2BPGi. The author would like to express his sincere appreciation for the contribution of Dr. Youichi Takahama (General Manager, Sysmex) in the development of the reagent kit, Dr. Masashi Mizokami (Director General, National Center for Global Health and Medicine) in the clinical study, Ms. Azumi Takahashi (AIST) for preparation of the manuscript and Dr. Kiyoko Flora Aoki-Kinoshita for providing valuable advice upon revision of the manuscript.
Financial & competing interests disclosure
The series of glycoproteomics projects to develop novel base technologies for glycoscience were supported by the New Energy and Industrial Technology Development Organization of Ministry of Economy, Trade and Industry for 10 years (2001–2011). The clinical development of M2BPGi was supported by the Sciences Research Grant of the Ministry of Health, Labor and Welfare for the innovative development and practical application of new drugs for hepatitis (2012–present date). HISCL M2BPGi Assay Kit was developed in collaboration of AIST and Sysmex Co. Cactus Communications provided language editing support. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Glycoprotein-based biomarkers (glyco-biomarkers) are developed based on the qualitative and quantitative detection of specific changes in the glycan structure(s) on a glycoprotein secreted from the diseased cells of interest.
In general, glyco-biomarkers are more specific and sensitive than conventional protein-based biomarkers.
Glycoproteomics technologies, which detect the glycosylation sites and attached structures as well as the carrier proteins in a comprehensive manner, will become essential in the efficient development of glyco-biomarkers.
In the development of new glyco-biomarkers, a rational strategic approach and appropriate analytical technologies are the most important elements.
Our technology and strategy were adopted in the development of a novel glyco-biomarker, M2BPGi, for the evaluation of liver fibrosis. The same approach can be applied for the development of a variety of diagnostic markers.