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 TCRA/D consists of an orange-labeled probe hybridizing proximal to the TCRA/D gene region at 14q11.2 and a green-labeled probe hybridizing distal to TCRA/D gene region at 14q11.2.

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

Chromosomal aberrations with breakpoints in T-cell receptor (TCR) gene loci are recurrent in several T-cell malignancies. The chromosomal alterations juxtapose oncogenes next to TCR regulatory sequences leading to deregulated expression of those oncogenes.

T-cell prolymphocytic leukemia (T-PLL) harbors frequent alterations of the TCRA/D locus, usually caused by an inv(14)(q11q32). By molecular cytogenetic studies, the incidence of TCRA/D rearrangements is about 24% of all T-cell acute lymphoblastic leukemia (T-ALL) cases.

Clinical Applications

  • Acute Lymphoblastic Leukemia (ALL)
  • Non-Hodgkin Lymphomas (NHL)
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XL TCRA/D hybridized to lymphocytes. One normal metaphase is shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green-orange (2GO) fusion signals representing the two normal TCRA/D loci.

Expected Pattern 2

Aberrant Cell (typical results):
One green (1G), one orange (1O), and one green-orange (1GO) fusion signal, indicating a chromosome break in the TCRA/D locus.

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  • Gesk et al (2003) Leukemia 17:738-745
  • Leich et al (2007) J Pathol 213:99-105
  • Feldman et al (2009) Am J Clin Pathol 130:178-185



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