In vitro diagnostics (IVDs)
Detection of tumor markers, which are proteins and DNAs specifically appearing in blood and urine due to cancer, is useful to assist cancer diagnosis.
Measurement of tumor-related autoantibodies –MESACUP™ anti-p53 TEST–
p53 protein plays key role in cell cycle, DNA repair, and apoptosis. Mutations in p53 gene result in disruption of p53 function and carcinogenesis in many tissues. The immune response in tumor patients correlates with the presence of a p53 mutation which leads to the abnormal accumulation of p53 proteins in the tumor cells. Anti-p53 antibodies are a useful marker for diagnosis and monitoring of the treatment responses in tumor patients, especially at early stage.
"MESACUP™ anti-p53 TEST" is a kit for the detection of anti-p53 antibodies and approved for diagnosis of esophageal, colon, and breast tumor by the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
New marker for multiple myeloma –Free Light Chains–
Measurement of immunoglobulin free light chains in serum is a new and sensitive test to diagnose monoclonal gammopathy such as multiple myeloma. The criteria for stringent complete remission of multiple myeloma proposed by the International Myeloma Working Group include normal ratios of free light chains (FLC ratio; κ chain /λ chain) in 2006.
"FREELITE κ Chain" and "FREELITE λ Chain" are useful for the measurement of free light chains. The kits can specifically and rapidly quantify serum free light chains with high sensitivity. In the U.S. and Europe, these kits have been used not only for diagnostic purposes, but also for disease monitoring, including determination of therapeutic effects. In Japan, MBL started marketing of "FREELITE κ Chain" and "FREELITE λ Chain" in August 2010, and these kits were covered by the Medical Reimbursement in September 2011. Approval of such in vitro diagnostics has long been awaited by various organizations such as the International Myeloma Foundation-Japan.
Marker for urothelial carcinoma –Bladder Check "NMP22"–
Nuclear matrix protein 22 (NMP22) is found in the nucleus of cells. In urothelial carcinoma, NMP22 becomes soluble due to cell death and is released into urine. Measurement of urinary NMP22 concentration is useful for diagnosis of urothelial cancer.
MBL provides "Bladder Check NMP22," a test reagent for conveniently detecting NMP22 in urine by an immunochromatographic method.