XL MLL plus

Break Apart 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.

Please use the switch to change to the IVDR product.

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Product Description

XL MLL plus

XL MLL plus consists of an orange-labeled probe hybridizing proximal to the KMT2A gene region at 11q23.3 and a green-labeled probe hybridizing distal to the KMT2A gene region at 11q23.3.

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

A number of recurrent chromosomal abnormalities have been shown to have prognostic significance in acute lymphoblastic leukemia (ALL), especially in B-precursor ALL. Some chromosomal abnormalities, such as high hyperdiploidy and the TEL-AML1 fusion, are associated with more favorable outcomes, while others, including the t(9;22), rearrangements of the KMT2A gene (chromosome 11q23), and intrachromosomal amplification of the AML1 gene (iAMP21), are associated with a poorer prognosis.

Chromosomal rearrangements involving the human KMT2A gene are recurrently associated with the disease phenotype of acute leukemias. The identification of KMT2A gene rearrangements is necessary for rapid clinical decisions resulting in specific therapy regimens. Amplification of KMT2A in myelodysplastic syndrome and acute myeloid leukemia has also been observed, and transcriptional similarities between KMT2A amplified and KMT2A rearranged leukemias were identified.

Clinical Applications

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML)
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XL MLL plus

XL MLL plus hybridized to bone marrow cells. Two aberrant interphase nuclei with one fusion signal and one separate orange and green signal each are shown, representing a translocation with KTM2A involvement.

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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 respective locus.

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  • Poppe et al (2004) Blood 103:229-235
  • Meyer et al (2006) Leukemia 20:777-784
  • Cavazzini et al (2006) Haematologica 91:381-385



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

New Probes Catalog is Online!


MetaSystems Probes is pleased to announce the new catalog including new and innovative products and supporting information. A PDF version of the new catalog is available for download here.

New Probes Catalog is Online!