KRIBIOLISA™ Dirucotide (MBP8298) ELISA

Immunoassay for quantitative estimation of Dirucotide in human serum, plasma and tissue extracts. Dirucotide (MBP8298) was developed by two research scientists (Dr. Kenneth G. Warren & Ingrid Catz at the University of Alberta) for the treatment of Multiple Sclerosis (MS). Dirucotide is a synthetic peptide that consists of 17 amino acids linked in a sequence identical to that of a portion of human myelin basic protein (MBP). The drug is exclusively licensed by BioMS Medical Corp., a Canadian-based biotechnology company.BioMS Medical received clearance from the Food & Drug Administration (FDA) to initiate a phase III clinical trial, named MAESTRO-03, for secondary progressive MS patients in January 2007. An additional Phase III clinical trial for dirucotide, MAESTRO-01, is being undertaken in Canada and Europe. In September 2008, the drug was granted FDA fast-track for approval. On July 2009, a statement was released, stating "BioMS Medical Corp. today announced that Dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO- 01 Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between Dirucotide and placebo on the secondary endpoints of the study", this means that the MAESTRO-02 and MAESTRO-03 trials are discontinued. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year The Dirucotide ELISA is a competitive immunoassay for the determination of Dirucotide. The antiserum is captured by antibodies coated on a 96-well plate. A constant concentration of Biotin Concentrate and varying concentrations of unlabeled standard or sample compete for binding specifically to the antiserum. Captured Bt-tracer is subsequently bound by SA-HRP (streptavidin-conjugated horseradish peroxidase), which produces a soluble colored product after a substrate is added. The enzyme reaction is stopped by dispensing an acidic solution (H2SO4) into the wells after 10 min at room temperature turning the solution from blue to yellow. The optical density (OD) of the solution at 450 nm is inversely proportional to the amount of specific Dirucotide bound.