Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XL 4q12
Translocation/Deletion Probe
- Order Number
- D-5063-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 044
- 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 4q12 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 an aqua-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.
Clinical Applications
- Myeloproliferative Neoplasm (MPN)
XL 4q12 hybridized to lymphocytes. Two normal interphases are shown with two blue-green-orange fusion signals each.
Normal Cell:
Two green-orange-blue colocalization/fusion signals
(2BGO).
Aberrant Cell (typical results):
One blue-green-orange colocalization/fusion signal (1BGO) and one blue-green colocalization/fusion (1BG) resulting from loss of one orange signal.
- Cools et al (2003) N Engl J Med 348:1201-1214
- Pardanani et al (2003) Blood 102:3093-3096
- Swerdlow et al (2017) WHO classification of tumors of haematopoietic and lymphoid tissues (revised 4th edition)
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.
