Xpert® BCR-ABL Ultra p190
Sensitive and quantitative monitoring of BCR-ABL p190 and ABL mRNA in patients with chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL)
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The Need

The ongoing presence of the Ph chromosome in ALL patients after consolidation therapy is a significant predictor of relapse, and monitoring is recommended. Established international organizations recommend definitive timepoints for monitoring BCR-ABL p190 in ALL and CML patients.7-10 Unlike the BCR-ABL World Health Organization international standard (WHO IS) for the p210 transcript, currently, there are no international standards that can be used to standardize the p190 fusion transcript Current testing options for BCR-ABL p190 monitoring for both CML and ALL patients are not only cumbersome, but can be expensive and time consuming for the lab to implement because:
  • Available testing methods can be complex and create inefficient laboratory workflows.
  • No international scale has been established for p190 monitoring, so laboratories are dependent on ratios and must run laborious standard curves.
(1)Reckel, S., Hamelin, R., Georgeon, S. et al. Differential signaling networks of Bcr–Abl p210 and p190 kinases in leukemia cells defined by functional proteomics. Leukemia 31, 1502–1512 (2017)
(2)Faderl S. et al. Clinical Significance of Cytogenic Abnormalities in Adult Acute Lymphoblastic Leukemia. Blood.1998; 91 (11): 3995-4019.
(3)Dushyant, V. et al. Chronic myeloid leukemia (CML) with p190 BCR-ABL: analysis and characteristics, outcomes and prognostic significance. Blood. 2009; 114: 2232-2235.
(4)Moorman, A. V. et al. A population-based cytogenetic study of adults with acute lymphoblastic leukemia. Blood 2010; 115:206-214.
(5)Burmeister, T. et al. Patient’s age and BCR-ABL frequency in adult B-precursor ALL: A retrospective analysis from the GMALL study group. Blood. 2008; 112:918-919.
(6)NCCN Clinical Practice Guidelines in Oncology Acute Lymphoblastic Leukemia v2.2019.
(7)NCCN Guidelines for Patients Acute Lymphoblastic Leukemia, 2021
(8)ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up of Acute Lymphoblastic Leukaemia
(9)Canadian Cancer Society Follow-up after treatment for acute lymphocytic leukemia.
(10)Foroni L, Wilson G, Gerrard G, Mason J, Grimwade D, White HE, de Castro DG, Austin S, Awan A, Burt E, Clench T, Farruggia J, Hancock J, Irvine AE, Kizilors A, Langabeer S, Milner BJ, Nickless G, Schuh A, Sproul A, Wang L, Wickham C, Cross NC. Guidelines for the measurement of BCR-ABL transcripts in chronic myeloid leukaemia. Br J Haematol. 2011 Apr;153(2):179-90.

The Solution

Xpert BCR-ABL Ultra p190 is an automated test for quantifying the amount of BCR-ABLp190 transcript as a ratio of BCR-ABL p190/ABLwith high sensitivity.

Based on the innovative GeneXpert® technology, Xpert BCR-ABL Ultra p190 automates the testing procedure, including RNA isolation, reverse transcriptionLeveraging Cepheid's lab in a cartridge™ technology, the Xpert BCR-ABL p190 test decreases workflow complexity and hands-on time by automating the entire testing process, delivering faster results.

Xpert BCR-ABL Ultra p190 is a quantitative test for the BCR-ABL minor breakpoint (p190) transcripts that provide high test sensitivity, standardization, and on-demand molecular results in ≤2.5 hours. With minimal hands-on time and a streamlined workflow, Xpert BCR-ABL Ultra p190 eliminates the need for time-consuming hands-on processes and enables the laboratory to run p190 testing in-house.

Simple & Easy to Use
  • ≤2.5 hours total testing process
  • Simply add treated blood sample and an off-board reagent to the Xpertcartridge
Sensitive & Robust Design
  • Includes two internal controls
  • 4 mL input volume of EDTA whole blood supports high test sensitivity for detection of low-level transcripts
  • High sensitivity and low inter-laboratory variation11
  • Clinically demonstrated limit of detection of 0.0065%11
(11)Xpert® BCR-ABL Ultra p190 Instructions for Use (part number 302-6673)

The Impact

Patient: Faster results reduce patient anxiety Ease of testing combined with same-day results could relieve the stress of waiting for results. Ease of testing combined with same-day results could relieve the stress of waiting for results. Clinician: Same day monitoring results support informed decisions Timely monitoring ensures the identification of high-risk patients associated with an inferior outcome to therapy with TKI.13
Laboratory: A CE-IVD cleared test with flexibility and simplicity for an easy, more optimized testing workflow
  • Flexible: Process any number of samples, any day of the week, with a fixed cost per reportable result, no wasted time, or reagents from batching requirements
  • Easy: Automated processing provides consistent data, decreases costs by eliminating standard curve and replicating testing requirements, allowing optimized lab organization by freeing up technician time for other lab activities
  • Standardized: Proprietary in-house RNA control materials are used to calibrate and standardize each lot of the Xpert BCR-ABL Ultra p190 assay to align indirectly with the WHO IS (NIBSC-09/138) for BCR-ABL p210.12
(12) Yuanyuan Liu, Tran Tran, Phat Nguyen, Huilin Wei, Gwo-Jen Day, Lin Yuan; Development of Reference Control Material for the Evaluation of the Cepheid Prototype * Xpert® BCR-ABL P190 Ultra Assay. Blood 2019; 134 (Supplement_1): 5213 (13) Verma D, Kantarjian HM, Jones D, Luthra R, Borthakur G, Verstovsek S, Rios MB, Cortes J. Chronic myeloid leukemia (CML) with P190 BCR-ABL: analysis of characteristics, outcomes, and prognostic significance. Blood. 2009 Sep 10;114(11):2232-5. doi: 10.1182/blood-2009-02-204693. Epub 2009 Jun 16. PMID: 19531657; PMCID: PMC4828071.