XL t(15;17) DF

Translocation/Dual Fusion Probe

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

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.

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Product Description

XL t(15;17) DF

XL t(15;17) DF consists of an orange-labeled probe hybridizing to the PML gene region at 15q24 and a green-labeled probe hybridizing to the RARA gene region at 17q21.1-21.2.

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

Several recurrent balanced translocations and inversions, and their variants, are recognized in the WHO category acute myeloid leukemia (AML) with recurrent genetic abnormalities. Furthermore, several cytogenetic abnormalities are considered sufficient to establish the WHO diagnosis of AML with myelodysplasia-related features if 20% or more blood or marrow blasts are present.

AML M3 and AML M3v are characterized by a reciprocal translocation between the long arm of chromosome 15 and the long arm of chromosome 17. This translocation leads to a rearrangement of the PML gene situated on chromosomal band 15q24 and the RARA gene situated on band 17q21. The PML-RARA rearrangement has gained major clinical importance because, in combination with all-trans retinoic acid (ATRA) and conventional anthracycline and cytarabine based chemotherapy, it leads to an improved prognosis in this subgroup of AML.

Clinical Applications

  • Acute Myelogenous Leukemia (AML)
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XL t(15;17) DF

XL t(15;17) DF hybridized to bone marrow cells. One orange, one green, and two fusion signals each are observed in the interphase nuclei indicating the presence of t(15;17).

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Expected Patterns

Expected Pattern 1

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

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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  • Grimwade et al (2000) Blood 96:1297-1308
  • Schoch et al (2002) Hematol J 3:259-263
  • Campbell et al (2013) BioMed Res Int: Article ID 164501



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