In vitro diagnostics (IVDs)
MBL researches, develops, manufactures and sells IVDs for autoimmune diseases, cancers, genetic diseases, infectious diseases, and allergies.
The immune system protects human bodies to aid in defence against foreign materials. However, this immune function is occasionally broken down and attacks our own tissues and cells as foreign invaders, resulting in ''autoimmunity'' or ''autoimmune diseases''.
Up to date, the number of ''biological drugs'' for autoimmune diseases has significantly increased. These drugs are expected to offer more effective treatment, especially if their administration starts early. The market of IVDs concomitantly changes in responce to the demand of not only accuracy of data, but also ''earlier detection'' or ''higher sensitivity''.
MBL covers a broad range of IVD reagents for autoimmune diseases. In order to highlight the clinical needs, MBL has offered the IVD kits with chemiluminescence technology along with ELISA kits. The chemiluminescence -based "STACIA® MEBLux™ test" series requires only 20 min to get a test result. The "STACIA® MEBLux™ test" series provides you with the potential to appropriately diagnose and treat within the day.
Antinuclear antibodies (ANAs)
Antinuclear antibodies (ANAs) are autoantibodies against various antigens of cell nuclei and found in patients with autoimmune diseases such as systemic lupus erythematosus (SLE). Although ANA test using immunofluorescence assay has been used for over 50 years, it is still considered as the "Gold Standard".
MBL is a leading company of ANA tests in Japan, and growing in the global market of this field.
Tests for anti-neutrophil cytoplasmic antibodies (ANCAs)
Anti-neutrophil cytoplasmic antibodies (ANCAs) have at tracted at tention as autoantibodies related to vasculitis. Presence of an ANCA can lead to activation of neutrophils that are stimulated to release cytotoxic enzymes within granules, which can cause vasculitis. Based on the patterns induced by indirect immunofluorescence staining using neutrophils as substrate, ANCAs with a granular cytoplasmic pattern are classified as C-ANCA, and those with a perinuclear pattern as P-ANCA. The major C-ANCA target antigen is proteinase III (PR3), and anti-PR3 antibody is a diagnostic criterion for Wegener's granulomatosis. The major P-ANCA target antigen is thought to be myeloperoxidase (MPO). Anti-MPO antibody is included among the diagnostic criteria for microscopic polyarteritis.
MBL provides clinical diagnostic reagents based on indirect immunofluorescence, ELISA, and chemiluminescence immunoassay.
Tests for autoimmune skin blistering diseases
Autoimmune blistering diseases are a group of disorders associated with disruption of intra-epidermal or sub-epidermal connections. They are rare diseases, but can lead to death. Pemphigus and pemphigoid are the two most common and most serious bullous diseases and prognosis of pemphigus is much worse than pemphigoid. Thus differential diagnosis of autoimmune blistering diseases is very important for patients' ''Quality of Life (QOL)''.
MBL has the largest market share in the world in the IVDs for autoimmune blistering diseases.
Marker for rheumatoid arthritis: anti-CCP antibodies
Anti-cyclic citrullinated peptide antibodies (anti-CCP antibodies) are a marker to rheumatoid arthritis (RA) with superior sensitivity and specificity. The anti-CCP antibodies are also useful for diagnosis of very early RA and incorporated in the 2010 ACR (American College of Rheumatology)/ EULAR (The European League Against Rheumatism) classification criteria for RA.
MBL launches several items for detection of anti-CCP antibodies to meet clinical needs, such as Chemiluminescence assay and Point-of-care (POC) testing as well as conventional ELISA. STACIA® MEBLux™ Test CCP (anti-CCP antibody measurement kit) is a test reagent for chemiluminescence immunoassay with shortened measurement of 19 minutes. ''MEBChrom™ CCP Test'', a POC test device, provides the detection of anti-CCP antibodies in whole blood, plasma, and serum.
Test for IgG4 –IgG subclass BS-NIA IgG4–
IgG4-related diseases, characterized by serum immunoglobulin G4 (IgG4) elevation and significant infiltration of IgG4-positive plasma cells into lesions, were first reported as autoimmune pancreatitis in Japan. Nowadays, IgG4-related diseases have been described in many organs, and been growing as a new disease concept. Differentiating from other diseases is considered to be quite important for appropriate treatment of IgG4-related diseases or prevention from side-effect. ''IgG subclass BS-NIA IgG4'' is extremely useful for diagnosis, monitoring disease activity, and following up for relapse of IgG4-related diseases. MBL keeps on going forward with the pioneers in the field and patients.