Human BCR-ABL (P210) Fusion Gene Detection Kit (Digital PCR)

The Human BCR-ABL (P210) Fusion Gene Detection Kit (Digital PCR) is used to quantify the proportion of the BCR-ABL (P210) fusion gene in human peripheral blood specimens obtained from patients previously diagnosed with t(9:22)-positive chronic myeloid leukemia (CML).

The kit measures the e13a2 and/or e14a2 transcripts of the BCR-ABL fusion gene and normalizes them to the ABL1 endogenous control. The results are reported as a percentage reduction from a baseline of 100% on the International Scale (%IS) and on a logarithmic molecular reduction (MR) scale.

Detecting BCR-ABL (P210) (e13a2 and/or e14a2) transcript levels during tyrosine kinase inhibitor (TKI) therapy in patients with chronic myeloid leukemia (CML) is crucial for evaluating treatment response and monitoring early relapse, which is essential for optimizing CML treatment.

Please note that the test does not distinguish between e13a2 and/or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). It is not intended for the initial diagnosis of CML.