Past event in Netherlands from Mar 19 to Mar 21, 2025
XL 4q12 DC
Translocation/Deletion Probe
- Order Number
- D-5123-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 044
- 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 4q12 DC probe is a qualitative, non-automated test for the detection of deletions of the CHIC2 gene region at 4q12 and breaks in PDGFRA at 4q12 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 chronic myelomonocytic leukemia (CMML), myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions (MLN-TK). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL 4q12 DC probe consists of a green-labeled probe hybridizing proximal to the FIP1L1 gene region at 4q12, an orange-labeled probe hybridizing to the CHIC2 gene region at 4q12 and another green-labeled probe hybridizing to the PDGFRA gene region at 4q12.
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 4q12 DC hybridized to lymphocytes. Two normal interphases and one metaphase are shown.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one green (1G) signal resulting from the loss of one orange signal.
Aberrant Cell (typical results):
One green (1G) and two green-orange colocalization/fusion signals (2GO) signals resulting from a translocation between the green labeled PDGFRA gene region and an unknown chromosome.
Tumour Genetics Symposium 2025
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