Past event in Netherlands from Mar 19 to Mar 21, 2025
XL MECOM 3q26
Break Apart Probe
- Order Number
- D-5059-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 033
- 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 Austria, Belgium, Croatia, Cyprus, Estonia, France, Germany, Iceland, Italy, Liechtenstein, Luxembourg, Malta, Netherlands, Slovenia, and Switzerland, with the list of countries continuously expanding.
The XL MECOM 3q26 break-apart probe is a qualitative, non-automated test for the detection of MECOM-rearrangements at 3q26.2 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 myeloid leukemia (AML), chronic myeloid leukemia (CML) and myelodysplastic neoplasms (MDS). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL MECOM 3q26 break-apart probe consists of an orange-labeled probe hybridizing proximal to the MECOM gene region at 3q26.2 and a green-labeled probe hybridizing distal to the MECOM gene region, also spanning into the distal part of MECOM at 3q26.2.
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 MECOM 3q26 hybridized to lymphocytes. One normal metaphase and one normal interphase are shown.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
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.
Aberrant Cell (typical results):
Two green-orange colocalization/fusion signals (2GO) and one separate usually small green (1G) signal indicating a variant chromosome break at a more distal region of the locus covered by the green probe.
Tumour Genetics Symposium 2025
Upcoming Event in Germany from May 8 to May 10, 2025
Meet our colleagues in Leipzig, Germany!
European Cytogenetics Conference
Upcoming Event in Belgium from Jun 29 to Jul 1, 2025
Meet our colleagues in Leuven, Belgium!
