Xpert BCR-ABL Monitor

Xpert® BCR-ABL Monitor

Simplified, Rapid Testing for Improved CML Patient Management

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  • Cepheid’s Xpert BCR-ABL Monitor test is a powerful tool for monitoring patients being treated for Chronic Myelogenous Leukemia. The unsurpassed sensitivity of the GeneXpert® System enables clinicians to process molecular tests in their own facilities instead of sending patient samples to a central lab and waiting for results. A patient’s local clinician can now monitor minimal disease levels very quickly — the key to appropriately managing patients who may be at risk for relapse.”

    - Dr. Ellie Nacheva, MD PhD FRCPath, III Head of Lab – Leukemia Cytogenetics,
    Royal Free and University College School of Medicine

    Current Guidelines:
    Current practice guidelines from Europe Against Cancer and National Comprehensive Cancer Network (NCCN) for management of patients with CML call for use of quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) assays during the initial workup of patients with chronic phase CML, in monitoring for minimal residual disease, and in identifying patients who may be at a high risk for relapse2,3.

    RT-PCR:
    RT-PCR has been shown to be an accurate and highly sensitive method for detection of the BCR-ABL fusion gene3-14, and is more sensitive than Fluorescence In Situ Hybridization (FISH) or cytogenetics3.

    An additional advantage of quantitative PCR versus FISH and cytogenetics is the high correlation of PCR results obtained from bone marrow and peripheral blood samples2,3. Therefore, PCR may potentially reduce the bone marrow aspirations currently required in patients with CML.

    International Standardization:
    The clinical utility of monitoring BCR-ABL mRNA levels has become standard of care in aiding physicians in managing their CML patients. Therefore, it is essential that variation between and within laboratories remain low.

    (1) Branford, Susan, et al. Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials, Blood, 15 Oct 2008, Volume 12, Number 8.; (2) Gabert J, Beillard E, van der Velden VH, et al. Standardization and quality control studies of ‘real-time’ quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia - a Europe Against Cancer Program. Leukemia. 2003; 17:2318-2357.; (3) NCCN. Clinical Practice Guidelines in Oncology; Chronic Myelogenous Leukemia. Version 1. 2006.; (4) Kantarjian HM, Talpaz M, Cortes J, et al. Quantitative polymerase chain reaction monitoring of BCR-ABL during therapy with imatinib mesylate (STI571;Gleevec) in chronic-phase chronic myelogenous leukemia. Clin Cancer Res. 2003; 9(1):160-6.; (5) Gabert J et al. Standardization and quality control studies of ‘real-time’ quantitative reverse transcriptase polymerase chain reaction of fusion gene transcripts for residual disease detection in leukemia-A Europe Against Cancer Program. Leukemia 2003; 1-40.; (6) Sawyers C. Chronic Myeloid Leukemia. NEJM. 1999;340(17): 1330-40.; (7) Deininger MW, Goldman JM, Melo JV. The molecular biology of chronic myeloid leukemia. Blood. 2000; 96(10):3343-56.; (8) Goldman JM, Kaeda JS, Cross NC. Clinical decision making in chronic myeloid leukemia based on polymerase chain reaction analysis of minimal residual disease. Blood. 1999; 94(4):1484-6.; (9) Radich JP. The detection and significance of minimal residual disease in chronic myeloid leukemia. Medicina (B Aires) 2000; 60 Suppl 2:66-70.; (10) Hochhaus A, Reiter A, Skladny H, et al. Molecular monitoring of residual disease in chronic myelogenous leukemia patients after therapy. Recent Results Cancer Res 1998; 144:36-45.; (11) Hochhaus A, Reiter A, Saussele S, et al. Molecular heterogeneity in complete cytogenetic responders after interferon-alpha therapy for chronic myelogenous leukemia: low levels of minimal residual disease are associated with continuing remission. German CML Study Group and the UK MRC CML Study Group. Blood. 2000; 95(1):62-6.; (12) Radich JP, Gehly G, Gooley T, et al. Polymerase chain reaction detection of the BCR-ABL fusion transcript after allogeneic marrow transplantation for chronic myeloid leukemia: results and implications in 346 patients. Blood 1995; 85(9):2632-8.; (13) Olavarria E, Kanfer E, Szydlo R, et al. Early detection of BCR-ABL transcripts by quantitative reverse transcriptase-polymerase chain reaction predicts outcome after allogeneic stem cell transplantation for chronic myeloid leukemia. Blood. 2001; 97(6):1560-5.; (14) Deininger M, Buchdunger E, Druker BJ. The development of imatinib as a therapeutic agent for chronic myeloid leukemia. Blood. 2005; 105(7):2640-2653.

    Xpert BCR-ABL Monitor:
    Xpert BCR-ABL is a real-time RT-PCR (Reverse Transcription Polymerase Chain Reaction) test intended as an aid in the monitoring of the p210 BCR-ABL translocation in peripheral blood lymphocytes (PBL) of patients with chronic myelogenous leukemia (CML). This revolutionary test offers unique features not available in current testing methods, including: minimal hands-on time while delivering answers in less than 2 hours.

    The GeneXpert System:
    The GeneXpert is the only system to combine sample preparation with real time PCR amplification and detection for fully integrated and automated nucleic acid analysis. The system purifies, concentrates, detects, and identifies targeted nucleic acid sequences in less than 2 hours. The GeneXpert System requires minimal hands on time. For BCR-ABL, after a short sample preparation step users simply add selected reagents and the prepared sample to the cartridge and the GeneXpert System does the rest.

    GeneXpert BCR-ABL/ABL Monitor Test (IS)
    Xpert BCR-ABL/ABL test  reports results to the International Scale by using an assay-specific conversion factor determined by comparison to an IS reference assay.  Reporting to the International scale gives reliable and consistent results allowing physicians to better manage their patients and facilitating assessment of a major molecular response (MMR=3 log reduction from the IS baseline).

    • Xpert® BCR-ABL Monitor Instructional Guide
    • Cepheid - The Molecular Diagnostics Leader
    • Catalog #: BCR-100N-10

      Xpert BCR-ABL Monitor-10
      Number of Tests: 10

    • How can I place an order?

      Submit your request using our Request Information form, or call 1.888.838.3222, select option 1.