RT PCR Kit

Detection method: one-step real-time PCR

CE IVD diagnostic kit enables detection and quantification of b2a2 (e13a2) and b3a2 (e14a2) BCR-ABL1 MAJOR fusion gene transcript variants. The detection is based on one-step RT-qPCR using fluorescently labelled probes. The quantification is evaluated as the copy number percentage ratio of BCR-ABL1 fusion transcripts to ABL1 reference gene transcripts. The detection and quantification of both fusion and reference gene transcripts is performed in one tube.

Clinical implications

The BCR-ABL1 MAJOR fusion gene variant occurs in 95% patients with chronic myelogenous leukemia (CML) and in 25% patients with acute lymphocytic leukemia (ALL). The chromosomal aberration leads to the dysregulation of the tyrosine kinase signaling pathway and to the manifestation of the oncological disease.

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