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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
Chronic myeloid leukemia (CML) accounts for approximately 15% of adult leukemias.1
Successful treatments with Tyrosine Kinase Inhibitors (TKIs) have greatly improved the outcome for most patients, significantly decreasing annual mortality and increasing prevalence.2,3
International guidelines recommend monitoring BCR::ABL1 transcript levels on an international reporting scale (IS) by quantitative RT-PCR (qPCR) at regular intervals to assess the efficacy and safety of the treatment.4-7
Successful treatments with Tyrosine Kinase Inhibitors (TKIs) have greatly improved the outcome for most patients, significantly decreasing annual mortality and increasing prevalence.2,3
International guidelines recommend monitoring BCR::ABL1 transcript levels on an international reporting scale (IS) by quantitative RT-PCR (qPCR) at regular intervals to assess the efficacy and safety of the treatment.4-7
1 Jabbour E, Kantarjian H. Chronic myeloid leukemia: 2020 update on diagnosis, therapy
and monitoring. Am J Hematol. 2020 Jun;95(6):691-709. doi: 10.1002/ajh.25792. Epub
2020 Apr 10. PMID: 32239758.
2 Sacha, Tomasz et al. The Outcomes of Ponatinib Therapy in Patients With Chronic
Myeloid Leukemia Resistant or Intolerant to Previous Tyrosine Kinase Inhibitors,
Treated in Poland Within the Donation Program. Clinical Lymphoma, Myeloma and
Leukemia, Volume 22, Issue 6, 405 – 415. Published:November 20, 2021. DOI:https://doi.
org/10.1016/j.clml.2021.11.012.
3 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.
4 Apperley JF, Milojkovic D, Cross NCP, et al. 2025 European LeukemiaNet
recommendations for the management of chronic myeloid leukemia. Leukemia.
2025;39(8):1797-1813. doi:10.1038/s41375-025-02664-w
5 Cross, N.C.P., Ernst, T., Branford, S. et al. European LeukemiaNet laboratory
recommendations for the diagnosis and management of chronic myeloid leukemia.
Leukemia 37, 2150–2167 (2023). https://doi.org/10.1038/s41375-023-02048-y
6 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.
7 NCCN. Clinical Practice Guidelines in Oncology (NCCN Guidelines^R) Chronic Myeloid
Leukemia (Accessed Version 1. 2026- July 16, 2025).
and monitoring. Am J Hematol. 2020 Jun;95(6):691-709. doi: 10.1002/ajh.25792. Epub
2020 Apr 10. PMID: 32239758.
2 Sacha, Tomasz et al. The Outcomes of Ponatinib Therapy in Patients With Chronic
Myeloid Leukemia Resistant or Intolerant to Previous Tyrosine Kinase Inhibitors,
Treated in Poland Within the Donation Program. Clinical Lymphoma, Myeloma and
Leukemia, Volume 22, Issue 6, 405 – 415. Published:November 20, 2021. DOI:https://doi.
org/10.1016/j.clml.2021.11.012.
3 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.
4 Apperley JF, Milojkovic D, Cross NCP, et al. 2025 European LeukemiaNet
recommendations for the management of chronic myeloid leukemia. Leukemia.
2025;39(8):1797-1813. doi:10.1038/s41375-025-02664-w
5 Cross, N.C.P., Ernst, T., Branford, S. et al. European LeukemiaNet laboratory
recommendations for the diagnosis and management of chronic myeloid leukemia.
Leukemia 37, 2150–2167 (2023). https://doi.org/10.1038/s41375-023-02048-y
6 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.
7 NCCN. Clinical Practice Guidelines in Oncology (NCCN Guidelines^R) Chronic Myeloid
Leukemia (Accessed Version 1. 2026- July 16, 2025).
The Solution
The Xpert BCR-ABL Ultra is a quantitative test for BCR::ABL major breakpoint (p210) transcripts that provides highly sensitive and on-demand molecular results, reporting on both the International Scale (IS) and Molecular Response (MR) formats.11
Accurate, on-demand process with results aligned to the IS in a one-page report in approximately 3 hours.11
Accurate, on-demand process with results aligned to the IS in a one-page report in approximately 3 hours.11
11 Xpert BCR-ABL Ultra Instructions for Use
The Impact
- Delivers same-day results to support informed and timely clinical decisions, aiding in improved patient care.8,9
- Flexibility and simplicity of an optimized and on-demand testing workflow improves overall cost and efficiency.10
- Eliminates the need for standard curve and replicate testing freeing up technician time for other lab services.11
8 Emily S Winn-Deen, Bret Helton, Reuel Van Atta, Wendy Wong, Jeffrey Peralta, James
Wang, Gregory J Tsongalis, Dorothy Belloni, David Chan, James R Eshleman, Christopher
D Gocke, Zsolt Jobbagy, Lan Beppu, Jerald P Radich, Development of an Integrated Assay
for Detection of BCR-ABL RNA, Clinical Chemistry, Volume 53, Issue 9, 1 September
2007, Pages 1593–1600, https://doi.org/10.1373/clinchem.2007.085472
9 Danzero AC, Gottardi EM, Quarantelli F, et al. An Automated Cartridge-Based
Microfluidic System for Real-Time Quantification of BCR::ABL1 Transcripts in Chronic
Myeloid Leukemia: An Italian Experience. Int J Mol Sci. 2025;26(18):8932. Published 2025
Sep 13. doi:10.3390/ijms26188932
10 S Haydon-Bradford et al. Implementing Quantitative BCR-ABL P210 Testing in a Rural
Healthcare Setting. Poster session presented at Association for Molecular Pathology
(AMP) 2023 Annual Meeting & EXPO; 2023 November 14-18; Salt Lake City, Utah.
11 Xpert BCR-ABL Ultra Instructions for Use
Wang, Gregory J Tsongalis, Dorothy Belloni, David Chan, James R Eshleman, Christopher
D Gocke, Zsolt Jobbagy, Lan Beppu, Jerald P Radich, Development of an Integrated Assay
for Detection of BCR-ABL RNA, Clinical Chemistry, Volume 53, Issue 9, 1 September
2007, Pages 1593–1600, https://doi.org/10.1373/clinchem.2007.085472
9 Danzero AC, Gottardi EM, Quarantelli F, et al. An Automated Cartridge-Based
Microfluidic System for Real-Time Quantification of BCR::ABL1 Transcripts in Chronic
Myeloid Leukemia: An Italian Experience. Int J Mol Sci. 2025;26(18):8932. Published 2025
Sep 13. doi:10.3390/ijms26188932
10 S Haydon-Bradford et al. Implementing Quantitative BCR-ABL P210 Testing in a Rural
Healthcare Setting. Poster session presented at Association for Molecular Pathology
(AMP) 2023 Annual Meeting & EXPO; 2023 November 14-18; Salt Lake City, Utah.
11 Xpert BCR-ABL Ultra Instructions for Use
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