Novel Serum Biomarkers in Liver Disease
Innumerable causes have been attributed to liver disease and early detection remains key to successful control and management of patients’ conditions before disease progression. Although liver biopsy remains the “gold standard” for evaluating liver fibrosis, its limitations as well as the invasive procedure make it unpopular among clinicians and patients alike. Serum biomarkers have various advantages, for instance being minimally invasive, safer and allow regular sampling, permit greater scrutiny of patient’s condition and disease progression. This is also operator independent, provides good assay reproducibility and more acceptable to patients.
Mac2-Binding Protein Glycosylation Isomer (M2BPGi) demonstrates numerous key advantages as a fibrosis marker [1]. In various studies on Japanese patients with hepatitis C, the staging of fibrosis by liver biopsy was consistent with M2BPGi levels [2]. It demonstrates very strong differential diagnosis of F3 and F4 liver disease cases in one study by Toshima el al. [3]. In combination with other test methods, it reduces the need to perform liver biopsy, and hence reducing burden on patients.
M2BPGi has substantial advantages compared to other conventional test methods. As a novel serum biomarker for liver disease, it demonstrates good accuracy in liver fibrosis identification and is currently approved for use in Japan since 2015 [4-5]. It imposes less burden on the patient, is affordable as a blood test and can be tested multiple times on a fully automated analyzer. In addressing a critical unmet need, M2BPGi aids in the assessment of liver disease progression. In a clinical case report with longitudinal measurements of M2BPGi levels, there was direct correlations to treatment response and significant reduction in M2BPGi measurements from the baseline result of more than 3.0 M2BPGi cut off index (C.O.I.). The patient has sustained M2BPGi levels around 1.0 C.O.I. and development of cancer was not observed for the 5 years follow up.

Professor Masashi Mizokami
Director
Genome Medical Sciences Project
National Center for Global Health and Medicine, Japan