XL BCR/ABL1 plus

Translocation/Dual Fusion Probe

Order Number
D-5052-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
922
Regulatory Status
IVDD

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 plus

XL BCR/ABL1 plus consists of 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/ABL 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/ABL active tyrosine kinase has become a major drug in treating CML, gastrointestinal stromal tumors, and other cancers.

Clinical Applications

  • Chronic Myelogenous Leukemia and Myeloproliferative Neoplasms (CML/MPN)
  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML)
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Images

XL BCR/ABL1 plus

XL BCR/ABL1 plus hybridized to bone marrow cells. Two interphase cells with two fusion signals and separated orange and green signals each are shown, indicating a BCR::ABL1 translocation.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green (2G) and two orange signals (2O).

Expected Pattern 2

Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.

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Literature

  • Dewald et al (1998) Blood 91:3357-3365
  • Huntly et al (2003) Blood 102:1160-1168
  • Primo et al (2003) Leukemia 17:1124-1129

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News

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

New Probes Catalog is Online!

 

MetaSystems Probes is pleased to announce the new catalog including new and innovative products and supporting information. A PDF version of the new catalog is available for download here.

New Probes Catalog is Online!