[The quality practice of molecular-genetic testing in the era of molecular target therapy in chronic myelogenous...

The advent of tyrosine kinase inhibitors as molecular target therapy has resulted in a marked change in the laboratory process for the diagnosis and therapeutic monitoring of chronic myelogenous leukemia. This includes defining the molecular typing of BCR-ABL1 to establish the diagnosis, a quantitative and/or high quality assay for minimal residual disease to evaluate the molecular response, and mutation analysis and chromosomal examination to assess its resistance to inhibitors. These processes should be used where appropriate for each patient. In the ongoing development and clinical use of novel agents for treatment of the leukemia, the quality assurance of each process of molecular-genetic testing, such as specimen handling, measurement, and reporting, has become increasingly important in the quality care of patients.