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 BCL3 BA consists of an orange-labeled probe hybridizing proximal to the BCL3 gene region at 19q13.3 and a green-labeled probe hybridizing distal to the BCL3 gene region at 19q13.3.

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

Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults. The clinical course is heterogeneous and ranges from good outcome to very aggressive and fast progressing disease. CLL is not characterized by a well-defined chromosomal translocation as many other lymphoid neoplasms. The most frequent aberrations are deletions on 6q21 (3-6%), 11q22-23 (5-20%), 13q14.3 (>50%) or 17q13.1 (3-8%) and trisomy 12 (10-20%).
The recurrent t(14;19)(q32.3;q13.3) is a rare event with an incidence of <0.1% in B-cell neoplasms and is often associated with trisomy 12 or a complex karyotype. It is also considered as a poor prognostic marker in CLL with inferior outcome. The translocation juxtaposes BCL3 with the immunoglobulin heavy chain gene region on chromosome 14, resulting in overexpression of BCL3. BCL3 is an oncogene involved in the regulation of NF-kappa-B target genes.

Since it is difficult to obtain metaphases from CLL patients, interphase FISH offers great advantage over conventional cytogenetics.

Clinical Applications

  • Chronic Lymphocytic Leukemia (CLL)
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XL BCL3 BA hybridized to bone marrow cells. One aberrant cell with split signal is shown, indicating a break in the BCL3 locus.

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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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  • Michaux et al (1996) Genes Chrom Can 15:38-47
  • Huh et al (2011) Am J Clin Pathol 135:686-696
  • Puiggros et al (2014) Biomed Res Int 2014:Article ID 435983



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