Upcoming 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
- IVDD
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 wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
XL t(10;11) MLLT10/KMT2A DF 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.
Clinical Applications
- Acute Lymphoblastic Leukemia (ALL)
- Acute Myelogenous Leukemia (AML)
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).
- De Braekeleer et al (2011) Mol Oncol 5:555-563
- Meyer et al (2013) Leukemia 27:2165- 2176
- Peterson et al (2019) Genes Chromosomes Cancer 58:567-577
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Feb 1, 2025: Rollout of IVDR-certified XCyting FISH Probes!
The first phase of this rollout includes the following countries: Austria, Cyprus, Estonia, Germany, Iceland and The Netherlands. More countries will be supplied over time.
