IVD kits for oncology

In the category of CE IVD kits for oncology, we present our comprehensive portfolio of products for one-step real-time RT-PCR detection and quantification of BCR-ABL1 fusion transcripts.

The BCR-ABL1 hybrid gene is the main product of the t(9;22)(q34;q11) translocation. Depending on the breakpoint in the BCR gene, three variants of the fusion gene have been characterized: MAJOR (M-bcr, e14a2, e13a2, also known as b3a2, b2a2), MINOR (m-bcr, e1a2), and MICRO (mu-bcr, e19a2, also known as c3a2). BCR-ABL1 transcripts are translated to the corresponding proteins: p210 (major), p190 (minor), and p230 (micro).

The MAJOR variant of BCR-ABL1 gene is found in more than 90 % of patients suffering from chronic myelogenous leukemia (CML). To monitor minimal residual disease (MMR), BCR-ABL1 transcripts are quantified to the copy number of the reference gene transcript (ABL1, GUSB). Efforts to standardize molecular monitoring of BCR-ABL1 MAJOR led to introduction of the laboratory recommendations (Cross at al., 2015) and to development of the international reporting scale (IS) which allows accurate comparison of results obtained by different laboratories.