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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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GXBCRABL-US-10
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The Need
Each year, 1.9 newly diagnosed Chronic Myelogenous Leukemia (CML) patients are identified per 100,000 individuals.1 CML prevalence is estimated to increase at an annual rate of 4%, and the number of individuals living with this disease will double by 2030.2
Managing CML in most diagnosed patients is achieved by oral administration of a Tyrosine Kinase Inhibitor (TKI) that specifically targets the activity of the BCR-ABL fusion protein. Currently, assessing treatment efficacy for CML requires a molecular diagnostic assay to measure the level of BCR-ABL transcript (RNA). Patients are tested for BCR-ABL every 3 months according to established international guidelines.3,4 Quantitative results are first normalized against a reference gene such as ABL.5 Subsequently, results are converted to an International Scale (IS) that harmonizes reporting of the molecular response.6
Despite efforts to optimise 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 for CML patient outcomes to improve.
Managing CML in most diagnosed patients is achieved by oral administration of a Tyrosine Kinase Inhibitor (TKI) that specifically targets the activity of the BCR-ABL fusion protein. Currently, assessing treatment efficacy for CML requires a molecular diagnostic assay to measure the level of BCR-ABL transcript (RNA). Patients are tested for BCR-ABL every 3 months according to established international guidelines.3,4 Quantitative results are first normalized against a reference gene such as ABL.5 Subsequently, results are converted to an International Scale (IS) that harmonizes reporting of the molecular response.6
Despite efforts to optimise 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 for CML patient outcomes to improve.
(1) According to SEER Database for US the incidence is 1.9 per 100000. https://seer.cancer.gov/statfacts/html/cmyl.html;
(2) 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.;
(3) NCCN guidelines
(4) National Comprehensive Cancer Network. (2019). Chronic Myeloid Leukemia (version 1.2019). Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/cml_blocks.pdf;
(5) O'Brien S, et al. Chronic myelogenous leukemia, version 1.2015. J Natl Compr Canc Netw. 2014 Nov;12(11):1590-610.;
(6) Beillard E, et al. Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using "real-time"quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR) – a Europe against cancer program. Leukemia. 2003 Dec;17(12):2474-86.
(7)Zackon, I., Beeks, A., Wei, D., Wentworth, C., Guo, J., McDermott, C., Jadhav, K., Herms, L., Damon, A., Sadek, I., & Benton, C. B. (2024). Real-World Treatment Patterns and Molecular Response (MR) Among Patients with Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP) in a Large Community Oncology Setting. Blood, 144(Supplement 1), 6611. https://doi.org/10.1182/blood-2024-210681
(2) 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.;
(3) NCCN guidelines
(4) National Comprehensive Cancer Network. (2019). Chronic Myeloid Leukemia (version 1.2019). Retrieved from https://www.nccn.org/professionals/physician_gls/pdf/cml_blocks.pdf;
(5) O'Brien S, et al. Chronic myelogenous leukemia, version 1.2015. J Natl Compr Canc Netw. 2014 Nov;12(11):1590-610.;
(6) Beillard E, et al. Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using "real-time"quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR) – a Europe against cancer program. Leukemia. 2003 Dec;17(12):2474-86.
(7)Zackon, I., Beeks, A., Wei, D., Wentworth, C., Guo, J., McDermott, C., Jadhav, K., Herms, L., Damon, A., Sadek, I., & Benton, C. B. (2024). Real-World Treatment Patterns and Molecular Response (MR) Among Patients with Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP) in a Large Community Oncology Setting. Blood, 144(Supplement 1), 6611. https://doi.org/10.1182/blood-2024-210681
The Solution
Xpert BCR-ABL Ultra is a quantitative test for BCR-ABL major breakpoint (p210) transcripts that provides highly sensitive and on-demand molecular results.
Based on the innovative GeneXpert® technology, Xpert BCR-ABL Ultra automates the entire test process including RNA isolation, reverse transcription, and fully-nested real-time PCR of BCR-ABL target gene and ABL reference gene, in one fully automated cartridge.
Ease of use
Based on the innovative GeneXpert® technology, Xpert BCR-ABL Ultra automates the entire test process including RNA isolation, reverse transcription, and fully-nested real-time PCR of BCR-ABL target gene and ABL reference gene, in one fully automated cartridge.
Ease of use
- < 2.5 hours total process
- Simply add treated blood sample and an off-board reagent to the Xpert cartridge
- Results aligned to the IS lot-to-lot through secondary standards calibrated to the BCR-ABL WHO panel
- Includes two internal controls
- 4 mL input volume of whole blood ensures reproducible detection of low-level transcripts
- High sensitivity and low inter-laboratory variation8
- Clinically demonstrated limit of detection of <4.5-log reduction (0.0030%)8
(8) Goldberg S, et al. Predictors of performing response monitoring in patients with chronic-phase chronic myeloid leukemia (CP-CML) in a prospective observational study (SIMPLICITY) 2015. (Suppl. 30): abstract 116, J Clin Oncol, Vol. 32.
The Impact
- Clinician: Same day information supports informed clinical decisions
- Patient: Faster results reduce patient anxiety
- Laboratory: Flexibility and simplicity for more streamlined workflow
- Decrease costs: Eliminates need for standard curve and replicate testing
- Optimised lab organisation: Free up technician time for other lab services
- Flexible: Any number of samples, any day of the week, with a fixed cost per reportable result
- Simple Reporting: One page report with results aligned to the IS
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