Due to the outstanding success of Chronic Myeloid Leukemia (CML) disease treatments, prevalence is increasing over time, and with the number of individuals living with this disease doubling by 2030.¹

Assessing treatment efficacy for CML requires a molecular diagnostic assay to measure the level of BCR-ABL transcript (RNA). Patients should be tested for BCR-ABL at regular intervals, guided by established international recommendations.^2,3,4

Recent studies have indicated that patients undergoing the recommended molecular assessments 3–4 times annually, experienced a reduced risk of progression and mortality, had improved TKI adherence, and generated lower health care costs compared to patients who were monitored less frequently.⁵

The Xpert BCR-ABL Ultra test is a quantitative test for BCR-ABL major breakpoint (p210) transcripts. The test provides highly sensitive and on-demand molecular results, reporting on both the International Scale (IS) and Molecular Response (MR) formats.
The Xpert BCR-ABL test automates the entire process including RNA isolation, reverse transcription, and fully-nested real-time PCR of BCR-ABL target gene and ABL reference gene in one automated cartridge.⁶
Easy to use
Simply add the treated sample and an off-board reagent to the GeneXpert® cartridge; no separate extraction needed. Internal controls ensure validity and accuracy, with less than 2.5 hours total process time, sample to result.⁶
Sensitive
ABL control gene copy number equivalence data highlights high sensitivity with low inter-laboratory variation, and proven linearity from 55-0.0030%IS.6 Clinically relevant limit of quantitation (LoQ) 0.0030IS/4.52MR.⁶
Standardized
Results are automatically aligned to the IS within the cartridge process, and standardized on a lot-to-lot basis via standards calibrated to the WHO panel.⁶