Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XL t(14;16) IGH/MAF DF
Translocation/Dual Fusion Probe
- Order Number
- D-5112-100-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(14;16) IGH/MAF DF consists of a green-labeled probe hybridizing to the IGH gene region at 14q32.3 and an orange-labeled probe hybridizing to the WWOX/MAF gene region at 16q23.
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.
The most frequent primary abnormalities in multiple myeloma (MM) are trisomies of odd-numbered chromosomes or translocations involving the immunglobulin heavy chain (IGH) gene locus. The most common MM-associated IGH translocations are t(11;14), t(4;14), t(6;14), t(14;16) and t(14;20) in the order of their occurrence. The consequence of these rearrangements is the dysregulation of genes juxtaposed to transcriptional enhancers in the IGH locus. Prognosis and risk stratification strongly depend on the detection and interpretation of cytogenetic primary abnormalities. t(14;16) and t(14;20) are considered as high risk, t(4;14) as intermediate risk and t(6;14) and t(11;14) as standard risk cytogenetic aberrations in patients with MM based on FISH testing. Secondary aberrations are also influencing the outcome.
MAF overexpression caused by t(14;16)(q32;q23) increases gene expression levels of the downstream target genes cyclin D2 and integrin beta 7 and contributes to the pathogenesis of MM by at least two mechanisms. Cyclin D2 is a major player in cell cycle regulation and Cyclin D2 dysregulation promotes tumor development. Furthermore, overexpression of integrin beta 7 affects the interaction between myeloma cells and bone marrow stroma and thus promotes transformation of malignant plasma cells.
Clinical Applications
- Multiple Myeloma and Plasma Cell Neoplasms (MM)
XL t(14;16) IGH/MAF DF hybridized to lymphocytes. One normal metaphase and one normal interphase are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the relevant loci.
- Chesi et al (1998) Blood 91:4457-4463
- Hurt et al (2004) Cancer Cell 5:191-199
- Rajan and Rajkumar (2015) Blood Cancer J 5:e365
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.
