Standardization of BCR-ABL1 p210 Monitoring: From Nested to Digital PCR

SIMPLE SUMMARY: The diagnostic and clinical success of standardization of BCR-ABL1 p210 monitoring in chronic myeloid leukemia patients could be seen as a good example for further standardization of molecular monitoring in other gene rearrangements. In this review, we present the chronology of more than 20 years of scientific work that allowed to achieve this result. We believe that this paper will be useful for researchers who approach the chronic myeloid leukemia field. ABSTRACT: The introduction of tyrosine kinase inhibitors in 2001 as a targeted anticancer therapy has significantly improved the quality of life and survival of patients with chronic myeloid leukemia. At the same time, with the introduction of tyrosine kinase inhibitors, the need for precise monitoring of the molecular response to therapy has emerged. Starting with a qualitative polymerase chain reaction, followed by the introduction of a quantitative polymerase chain reaction to determine the exact quantity of the transcript of interest-p210 BCR-ABL1, molecular monitoring in patients with chronic myeloid leukemia was internationally standardized. This enabled precise monitoring of the therapeutic response, unification of therapeutic protocols, and comparison of results between different laboratories. This review aims to summarize the steps in the diagnosis and molecular monitoring of p210 BCR-ABL1, as well as to consider the possible future application of a more sophisticated method such as digital polymerase chain reaction.