Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XL t(11;19) KMT2A/MLLT1 DF
Translocation/Dual Fusion Probe
- Order Number
- D-5136-100-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(11;19) KMT2A/MLLT1 DF consists of a green-labeled probe hybridizing to the KMT2A gene region at 11q23.3 and an orange-labeled probe hybridizing to the MLLT1 gene region at 19p13.3.
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(11;19) KMT2A/MLLT1 DF hybridized to bone marrow cells, one aberrant cell is shown. Translocations are typically observed as one orange and one green signal clearly separated and two orange-green colocalization/fusion signals.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical result):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.
- Meyer et al (2005) Proc Natl Acad Sci USA 102:449-454
- De Braekeleer et al (2011) Mol Oncol 5:555-563
- Winters and Bernt (2017) Front Pediatr 5 (4):doi:10.3389/fped.2017.00004
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.
