Break Apart Probe

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

IVDR Certification

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

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Product Description


XL BCL2 BA consists of an orange-labeled probe hybridizing proximal to the BCL2 gene region at 18q21.3 and a green-labeled probe hybridizing distal to the BCL2 gene region at 18q21.3.

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

The BCL2 gene rearrangement can be found in 50% of follicular lymphoma, 23.3% of B-cell lymphoma, and about 15% of diffuse large B-cell lymphoma. A consequence of this translocation is an overexpression of anti-apoptotic protein BCL2, which most likely represents the initial step of malignant transformation.
The majority of rearrangements in BCL2 occur at two distinct chromosomal regions, the major breakpoint cluster region (MBR) in 70% and the minor cluster region in 10% of patient's tumors.
FISH has been shown to be of higher sensitivity and of equivalent specificity when compared to PCR on paraffin-embedded tissue sections.

Clinical Applications

  • Non-Hodgkin Lymphomas (NHL)
  • Solid Tumors (Solid Tumors)
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XL BCL2 BA hybridized to a prostate tissue section. The normal green-orange fusion signal pattern is observed.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green-orange colocalization/fusion signals (2GO).

Expected Pattern 2

Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the relevant locus.

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  • Vaandrager et al (2000) Blood 96:1947-1952
  • Godon et al (2003) Leukemia 17:255-259
  • Weinberg et al (2007) J Mol Diagn 9:530-537



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