Clarity™
Major and Minor BCR-ABL Mutation Quantification Kit

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Chronic myeloid leukaemia (CML) and acute lymphoblastic leukemia (ALL) are characterized by the generation of Philadelphia (Ph) chromosome which arises from translocation between chromosomes 9 (region q34: ABL) and 22 (region q11: BCR). This translocation results in the formation of BCR-ABL fusion gene whereby majority of the breakpoints occurs in two regions; after the 13th exon resulting in a b2a2 (e13a2) fusion or after the 14th exon resulting in a b3a2 (e14a2) fusion. These fusions are mostly detected in CML patients and are translated into the constitutively active tyrosine kinase of 210kDa (P210). In Ph-positive ALL patients, the breakpoint typically occurs in the region after the 1st exon, resulting in the formation e1a2 fusion. This e1a2 fusion mRNAs are translated into the P190 constitutively active tyrosine kinase. Molecular detection and quantification of the BCR-ABL fusions are essential for disease diagnosis, monitoring of therapeutic responses and minimal residual disease detection.
The Clarity™ Major BCR-ABL Mutation Quantitation Kit and Clarity™ Minor BCR-ABL Mutation Quantitation Kit provide reagents optimized for the quantitative detection of b2a2 and/or b3a2 mutant cDNA* and e1a2 mutant cDNA* respectively in human whole blood samples using the Clarity™ digital PCR instrument.