BCR-ABL Mutation Detection Kit

BCR-ABL Mutation Detection Kit

  • Item No :ADx-AB01
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BCR-ABL Mutation Detection Kit

    The AmoyDx BCR-ABL Mutation Detection Kit is a sensitive and selective assay for the detection of the T315I mutation in the BCR-ABL gene. The majority (95%) of patients with chronic myelogenous leukemia (CML) have a chromosomal rearrangement that produces the BCR-ABL1 fusion oncogene. Patients with CML typically respond very well to treatment with the tyrosine kinase inhibitor imatinib mesylate [1], known as Gleevec in the US and Glivec in Europe. However, CML cells in patients treated with TKIs may develop resistance to the drug due to the appearance of the T315I point mutation in the BCR-ABL kinase domain [2]. New inhibitors such as dasatinib and nilotinib are significantly more potent than imatinib and may overcome resistance.


    1. Druker BJ, et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 2001;344:1031–7.

    2. Jabbour E, et al. Characteristics and outcomes of patients with chronic myeloid leukemia and T315I mutation following failure of imatinib mesylate therapy. Blood 2008;112:53–5.

    Intended Use: 
    For research purpose use only.
    Technological Principles: 
    The BCR-ABL mutation detection kit employs a proprietary real-time PCR format to specifically amplify mutant DNA and a fluorescent probe to detect the amplicon. The method is much more specific and sensitive than alternative technologies such as DNA sequencing.

    Key Features and Benefits:

    • Simple Procedure — only one step required for sample application. Results within 90 minutes.
    • High sensitivity and accuracy — can detect 1% mutant DNA in a background of wild type genomic DNA.
    • ADx-ARMs technology — employs a patented two-step PCR amplification procedure and novel fluorescent probe design.
    • Easy Standardization — any general PCR lab can perform the test, and technicians obtain reproducible results without specialized training.
    • Reliable product quality — Produced in a dedicated GMP plant, with quality management systems that have passed Chinese CFDA and international ISO13485 standards.

    • Sample type: Fresh, frozen or paraffin embedded tissue; blood, serum or plasma.

    Customer Service Hotline: 86-592-680-6835

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AmoyDx BCR-ABL Mutation Detection kit provides reagents to perform assays for 24 tests::

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 BCR-ABL Mutation Detection Kit




                 *   For Research Use Only

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