Chronic myeloid leukemia (CML) is a malignant bone marrow proliferative tumor originating from hematopoietic stem cells (HSC), with an annual incidence of 1-2/100,000 and accounting for 15-20% of all adult leukemias. The test results of BCR-ABL1 p210 fusion gene (fusion transcripts type e13a2 and/or e14a2) can be used for clinical diagnosis of Chronic Myeloid Leukemia (CML), and monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs). 

MEDx Translational Medicine has established production workshops that meet the quality assurance requirements of ISO 13485, with a standard production process and strict quality control. Our BCR-ABL RT-qPCR Test (CE IVD) is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 (fusion transcripts type e13a2 and/or e14a2) and ABL1 transcripts in total RNA from whole blood. The test results of BCR-ABL1 p210 fusion gene (fusion transcripts type e13a2 and/or e14a2) can be used for clinical diagnosis of Chronic Myeloid Leukemia (CML), and monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).