OBJECTIVES: In the US the monitoring of patients with Chronic Myeloid Leukaemia (CML) presents extensive intra- and inter-lab variability, thus a standardised, automated test should allow for improvement in patient management and health outcomes. The aim of the study was to estimate the budget impact and improved testing accuracy associated with a the use of a standardised, automated BCR-ABL monitoring test (SBAT) when compared to laboratory developed tests (LDTs) for newly diagnosed CML patients over a 5-year period in the US. METHODS: Epidemiology data regarding the incidence of Philadelphia positive (Ph+) CML patients who would be treated with a tyrosine kinase inhibitor (TKI) were combined with workflow cost and accuracy (sensitivity and specificity) data associated with the sequential testing and monitoring of newly diagnosed CML patients. A survey of US laboratories was conducted to determine the labour and materials costs associated with the SBAT versus LDTs. A testing algorithm based on NCCN guidelines was used to capture a number of different tests including testing for major molecular response (SBAT versus LDTs), complete cytogenetic response (routine and FISH- fluorescence in situ hybridisation), and mutation analysis. RESULTS: Results indicate that the SBAT is both less resource- and labour- intensive, and can be carried out at a cost that is lower than when an LDT is used. In addition, overall test accuracy increases when the SBAT is used instead of an LDT. For example, for every 100 patients who follow BCR-ABL monitoring according to NCCN guidelines, savings of approximately $386,180 and approximately 327 more accurate test results could be achieved over 5 years. CONCLUSIONS: The benefits from a SBAT when compared to LDTs are not only from the reduction of intra- and inter-lab variability (increased accuracy) but also in economic terms due to lower overall costs. Therefore, a SBAT represents a cost-saving alternative versus LDTs.