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

Human BCR-ABL (P210) Fusion Gene Detection Kit (Digital PCR) is used to quantify the proportion of BCR-ABL(P210) (e13a2 and/or e14a2) fusion gene in human peripheral blood specimens from patients previously diagnosed with t(9:22) positive chronic myeloid leukemia (CML).

The test measures the e13a2 and/or e14a2 transcripts of BCR-ABL, normalized to the ABL1 endogenous control. Results are reported as percent reduction from a baseline of 100% on the International Scale (%IS) and on a log molecular reduction (MR) scale.

Detection of BCR-ABL(P210) (e13a2 and/or e14a2) transcript levels during tyrosine kinase inhibitor (TKI) therapy in patients with chronic myeloid leukemia (CML) to properly evaluate treatment response and monitor early relapse is important and positive for optimizing CML treatment.

The test does not differentiate between e13a2 and/or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). The test is not intended for the diagnosis of CML.

intended for the diagnosis of CML.