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Clinical Diagnostics Business

Autoimmune Disease Area

MBL has been leading the clinical diagnostics market for over 30 years.

An autoimmune disease is a state in which a disorder of the immune mechanism causes it to mistakenly identify and attack body’s own tissues and cells as foreign objects. Autoimmune diseases are broadly categorized into systemic autoimmune diseases and organ-specific autoimmune diseases. Many autoimmune diseases are designated as intractable diseases by Japan’s Ministry of Health, Labour and Welfare (MHLW).
Diagnosis of autoimmune diseases requires accurate measurement of parameters and indicators which are specific to individual immune disorders. Laboratory test results also serve to not only diagnose patient condition but also predict subsequent disease progression and determine a course of treatment. MBL provides diagnostic reagents covering a broad range of autoimmune diseases and provides support for a variety of laboratory procedures from basic health screening to follow-up tests.
MBL is at the top of the clinical diagnostics segment in terms of the “number of parameters for assay with diagnostic reagents” newly registered in the national reimbursement price list during the period from February 2003 to December 2016. Thus, MBL has been leading the clinical diagnostics market for over 30 years since the establishment of its own research and development, production, and marketing system in 1983.

Genetic Testing

MBL provides genetic test products that assist the selection of optimal treatment regimens for cancer and other diseases.

In recent years, personalized medicine has become recognized as particularly important in selecting and designing optimal treatment regimens for individual patient. Personalized medicine is treatment optimally tailored to individual patient’s needs based on not only routine clinical information but also genomic background and physiological status as determined by disease-related biomarkers. Biomarkers are the subset of markers that serve as indicators of patient response to treatment, such as change in disease status, treatment effect, and adverse reactions, by measuring biological substances including proteins and genes. In molecular targeted therapy*, potentially responsive patients are identified based on the measurement of various biomarkers prior to treatment initiation and then the expected efficacy is determined. Thus, the tailoring contributes to the maximization of efficacy and minimization of adverse reactions. In particular, biomarkers for tailoring are required to be capable of not only identifying a specific mutation but also providing information on multiple gene mutations. MBL reagents meet these requirements with their simple, convenient, and cost-effective genetic diagnostic systems.

* Molecular targeted therapy: A therapeutic approach to target key molecules of cancer cells and inhibit the biological function of those molecules.

Tumor Marker Testing

Tumor markers are proteins and genes that are specifically produced by tumor cells and released into the circulation and can thus be measured in the blood and urine in certain amounts as signs of tumors. MBL supports accurate diagnosis of cancers with its diagnostic reagents of tumor markers and those of autoantibodies to tumor markers.

Pathological Tissue Examination

MBL contributes to the progress in pathology and pathological examination with its extensive product lines (research reagents), including immunohistochemical staining antibodies, various detection kits, and in situ hybridization reagents.

Cytological Testing

Cytological testing is a test to collect cells from the target area of the body and pathologically determine malignancy or benignancy of the cells under microscopy. The test is particularly useful for the diagnosis of uterine cancer. MBL provides and pursues higher accuracy of cytological testing through standardization and supply of a liquid-based cytological testing system, “TACAS™,” which can also be used for other types of test (e.g. genetic tests and immunocytochemistry staining assays).

NB: Available only in Japan.

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