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According to NCCN and ELN Guidelines, the monitoring of BCR-ABL1 transcript levels is central to care of Chronic Myeloid Leukemia (CML) patients. Previous studies have shown that, in the US, a high proportion of CML patients do not receive the recommend frequency of BCR-ABL testing.  Efforts have been made to standardize technical aspects of monitoring, but a large degree of variation remains in many other aspects of the BCR-ABL testing process, for example test requisition and result reporting. Therefore physicians are required to collect, assimilate and interpret a large amount of, often technical, information associated monitoring CML patients. 

 The aim of this study was to quantify the variation in the BCR-ABL testing pathway, from test availability through to result reporting. An additional objective was to use a national database to analysis testing rates for CML patients.  

Insurance claims data and independent information from clinical laboratories were used to map and evaluate the current US BCR-ABL1 testing landscape.  This study included analysis of test availability (including geographic reach), test request forms, turn around times (TAT), cost (as billed by the laboratory), methodology, sample reports and number of tests performed and billed.

Between June 2013 and May 2014, BCR-ABL1 testing was offered by 209 US clinical laboratories, of which, 137 laboratories conducted the testing in-house.  The remaining 72 laboratories sent this testing to 26 laboratories, 22 of which were used by only a single referring laboratory. Geographic spread of the laboratories was not uniform, e.g. 16 laboratories in California whereas only one laboratory in each of 9 other states. 21% of laboratories stated they report on the International Scale (IS), with 77% not providing this critical information. Only 30% (6/20) of test request forms specified transcript types for which testing is available. TAT and cost varied from 2-14 working days and $187-$497 respectively. Only 22% (4/18) of laboratory reports included full test methodology details, graphical representation of historical results and clear interpretative comments in line with current NCCN guidelines. The testing frequency of CML patients was found to be <1 test per annum, much lower than current guidelines recommend.  

Availability of quantitative BCR-ABL1 testing appears to be adequate in the US, however, our data show that in those states with fewer laboratories offering BCR-ABL quantitation, a physician is less likely to have access to a laboratory offering testing on the International Scale. The heterogeneous landscape for BCR-ABL1 testing is likely contributing to insufficiently-informed testing choices, testing frequency and, ultimately, treatment choices.  The inadequate and inconsistent information available for physicians poses a barrier to supporting them in choice of testing laboratory and in determining actionable outcomes from patient test results. A more uniform and integrated approach is needed to better support physicians and to ensure optimal patient care.