Past event in Netherlands from Mar 19 to Mar 21, 2025
XL t(10;11) MLLT10/
KMT2A DF
Translocation/Dual Fusion Probe
- Order Number
- D-5134-100-OG
- Package Size
- 100 µl (10 Tests)
- Regulatory Status
- IVDR
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
Please use the switch to change to the IVDD product.
IVDDIVDRDiscover all IVDR-certified productsDownload Instructions For Use (IFU)
Until further notice, we will continue to provide IVDD products in various countries.
As part of our phased rollout, the IVDR-certified probes are now available in Australia, Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Iceland, Italy, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, New Zealand, Poland, Slovakia, Slovenia, South Africa, and Switzerland, with the list of countries continuously expanding.
The XL t(10;11) MLLT10/KMT2A DF dual-fusion probe is a qualitative, non-automated test for the detection of KMT2A::MLLT10-rearrangements t(10;11)(p12.3;q23.3) by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL t(10;11) MLLT10/KMT2A DF dual-fusion probe consists of an orange-labeled probe hybridizing to the MLLT10 gene region at 10p12.3 and a green-labeled probe hybridizing to the KMT2A gene region at 11q23.3.
Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.
Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.
XL t(10;11) MLLT10/KMT2A DF hybridized to bone marrow cells, two aberrant cells are shown. An insertion of portions of the green signal into the orange signal has occured generating a pattern of 2 green, one orange and one green-orange colocalization/fusion signal.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G), one orange (1O), and one green-orange colocalization/fusion signal (1GO).
Aberrant Cell (typical results):
Two green (2G), two orange (2O), and one green-orange colocalization/fusion signal (1GO).
Tumour Genetics Symposium 2025
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