Xpert® BCR-ABL Ultra
Sensitive and quantitative monitoring of BCR-ABL mRNA in patients with chronic myelogenous leukemia (CML)
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The Need

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
1 Huang X, et al. Estimations of the increasing prevalence and plateau prevalence of chronic myeloid leukemia in the era of tyrosine kinase inhibitor therapy. Cancer. 2012 Jun 15;118(12):3123-7.
2 Hochhaus et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia, March 2020
3 Hochhaus A. et al. Chronic myeloid leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow up. Annals of Oncology. 2017 May; 28(4):iv41-iv51.
4 NCCN. Clinical Practice Guidelines in Oncology; Chronic Myelogenous Leukemia (Access Version 1, 2019).
5 P.E. Westerweel et al. Impact of hospital experience on the quality of tyrosine kinase inhibitor response monitoring and consequence for chronic myeloid leukemia patient survival. Haematologica. 2017 Dec; 102(12): e486–e489

The Solution

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
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
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
6 Xpert BCR-ABL Ultra Package Insert 302-0742 Rev.C. GXBCRABL-10

The Impact

Patient: Faster results
Despite efforts to optimize disease management, only one-third of newly diagnosed CML patients are adequately monitored during the first year of treatment.7 Therefore, more accessible molecular testing is needed to enhance CML patient outcomes.

Clinician: Same day information supports informed clinical decisions.
Timely CML monitoring results ensure that milestone “warning” responses are rapidly identified and acted upon, and may lower patient care costs.7

Laboratory: CE-IVD and FDA cleared test with flexibility and simplicity for an easy, more optimized testing workflow.
  • Flexible: Any number of samples, any day of the week with a fixed cost per reportable result, no wasted time or reagents from batching requirements.
  • Simple Reporting: Results align to the IS automatically and are also shown in Molecular Response (MR) format. No additional work is required to align to the International Scale via Conversion Factors.t
  • Easy: Automated processing provides consistent data, eliminates standard curve and replicate testing requirements, enables optimized lab organization
7 Goldberg S et al. First-line treatment selection and early monitoring patterns in chronic phase-chronic myeloid leukemia in routine clinical practice: SIMPLICITY. Am J Hematol. 2017 Nov 28;92:1214–1223. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5659133/