Deletion/Dual Fusion Probe

Order Number
Package Size
100 µl (10 Tests)
Regulatory Status

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.

Please use the switch to change to the IVDR product.

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Product Description


XL BCR/ABL1/ASS consists of an aqua-labeled probe hybridizing to the ASS1 gene region at 9q34.1, an orange-labeled probe hybridizing to the ABL1 gene region at 9q34.1 and a green-labeled probe hybridizing to the BCR gene region at 22q11.2.

Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.

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Clinical Details

Chronic myelogenous leukemia (CML) is genetically characterized by the presence of the reciprocal translocation t(9;22)(q34;q11), resulting in a BCR/ABL1 gene fusion on the derivative chromosome 22, called the Philadelphia (Ph) chromosome. The same translocation can also be found in acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) with some variation in the breakpoint region. Glivec® (imatinib mesylate) treatment targeting the BCR/ABL1 active tyrosine kinase has become a major drug in treating CML, gastrointestinal stromal tumors, and other cancers.

Deletions at the t(9;22) breakpoint regions, found in 5% of CML patients with a Ph translocation, have been associated with resistance to treatment in patients receiving tyrosine kinase inhibitors.

Clinical Applications

  • Chronic Myelogenous Leukemia and Myeloproliferative Neoplasms (CML/MPN)
  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML)
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XL BCR/ABL1/ASS hybridized to lymphocytes. One normal metaphase is shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two blue-orange (2BO) fusion signals and two separate green signals (2G).

Expected Pattern 2

Aberrant Cell (typical results):
One blue-orange colocalization/fusion signal (1BO), one green (1G), one blue-green-orange colocalization/fusion signal (1BGO) and one greenorange colocalization/fusion signal (1GO).

Expected Pattern 3

Aberrant Cell (typical results):
One blue-orange (1BO), two green (2G), and one green-orange (1GO) fusion signal, indicating a deletion at 9q34 in addition to a t(9;22).

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  • Dewald et al (1998) Blood 91:3357-3365
  • DeMelo et al (2008) Canc Genet Cytogenet 182:111-115
  • Luatti et al (2012) Blood 120:761-767



IVDR Certification

MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.

IVDR Certification