Xpert® BCR-ABL Ultra

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Sensitive and quantitative monitoring of BCR-ABL mRNA in patients with chronic myelogenous leukemia (CML)

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GXBCRABL-10

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The Need

Current Guidelines:
Each year 1.0-1.5 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 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 for CML patient outcomes to improve.

1) Goldman J. Chronic Myeloid Leukemia. 2008, Leukemia, Vol. 37, pp. 195-197.;
(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) Baccarani M, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: Blood. 2013 Aug 8;122(6):872-84.;
(4) O'Brien S, et al. Chronic myelogenous leukemia
(5) 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.;
(6) Branford S, et al. Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia. Leukemia. 2006 Nov;20(11):1925-30.;
(7) 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 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.,Benefits:

2.5 hours for the total process
Simply add the treated blood sample and an off-board reagent to the Xpert cartridge
The results are aligned to the IS lot-to-lot through secondary standards calibrated to the BCR-ABL WHO panel
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 (0.0032%)⁸
Same day information supports informed clinical decisions, including inclusion in treatment discontinuation research
Faster results reduce patient anxiety⁹
Flexibility and simplicity for more streamlined workflow
Eliminates need for standard curve and replicate testing
Frees up technician time for other lab services
Any number of samples, any day of the week with a fixed cost per reportable result
One page report with results aligned to the IS

Performance:
The clinical performance of Xpert BCR-ABL was evaluated by comparison with an in-house assay based on the Europe Against Cancer (EAC) standardized 'real-time' quantitative reverse transcriptase polymerase chain reaction (RQ-PCR) of fusion gene transcripts for residual CML disease.¹⁰ This routine assay was calibrated for the ABL reference gene and BCR-ABL target gene using the Institute for Reference Materials and Measurements (IRMM) plasmid dilutions. In the study, peripheral blood was acquired prospectively from subjects with CML into EDTA tubes. Each specimen was split for comparison testing with the routine assay and the Xpert BCR-ABL Ultra assay. Total recruitment included 54 subjects whose paired results were within the detectable range of both assays.

(8) Cepheid Xpert BCR-ABL Ultra Package Insert 301-2194.;
(9) Cepheid Europe Survey of LMC France (French CML Association). Improving the Quality of Life for Your CML Patients: A Patient Survey Analysis. 2014.Cepheid Europe Survey of LMC France (French CML Association). Improving the Quality of Life for Your CML Patients: A Patient Survey Analysis. 2014.;
(10) Gabert J, et al. Standardization and quality control studies of 'real-time'quantitative reverse transcriptase polymerase chain reaction (RQ-PCR) of fusion gene transcripts for residual disease detection in leukemia – A Europe Against Cancer Program: Leukemia. 2003 Dec;17(12):2318-57.;