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 TLX3 BA consists of an orange-labeled probe hybridizing proximal to the TLX3 gene region at 5q35.1 and a green-labeled probe hybridizing distal to the TLX3 gene region at 5q35.1.

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

Acute lymphoblastic leukemia (ALL) is the most common childhood cancer type. T-cell acute lymphoblastic leukemia (T-ALL) is an aggressive and quickly progressing type of ALL affecting T-lymphocytes. Genomic data suggests that more than 10 functional aberrations are contributing to the development of this disease. T-ALL cases can be grouped by distinct genetic profiles and the aberrant expression of a characteristic transcription factor. Major subgroups are characterized by ectopic expression of TAL1, TLX1, TLX3, HOXA9/10, LMO2 or NKX2-1 and others as a result of chromosomal rearrangements or mutations. About 20% of childhood T-ALL cases are characterized by aberrant expression of TLX3 as a result of t(5;14)(q35;q32). This cryptic translocation juxtaposes TLX3, normally not expressed in T-cells, with the BCL11B gene, which is active in T-cells, resulting in ectopic expression of TLX3.
Fluorescence in situ hybridization is a valuable method for the detection of t(5;14)(q35;q32) since cryptic translocations may escape during classical cytogenetic analysis. Furthermore, the broad range of breakpoints in the chromosomal region 14q32 makes the development of efficient PCR-based methods difficult.

Clinical Applications

  • Acute Lymphoblastic Leukemia (ALL)
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XL TLX3 BA hybridized to lymphocytes. One normal interphase and metaphase are shown.

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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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  • Van Zutven et al (2004) Haematologica 89:671-678
  • Su et al (2006) Blood 108:4198-4201
  • Girardi et al (2017) Blood 129:1113-1123



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