MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
XL t(14;20) IGH/MAFB DF
Translocation/Dual Fusion Probe
- Order Number
- D-5105-100-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 large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
XL t(14;20) IGH/MAFB DF consists of a green-labeled probe hybridizing to the IGH gene region at 14q32.3 and an orange-labeled probe hybridizing proximal to the MAFB gene region 20q12.
Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.
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 depends 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.
Even if associated with poor prognosis in MM, monoclonal gammopathy of undetermined significance/smoldering multiple myeloma (MGUS/SMM) cases characterized by t(14;20) can be stable for years before progression occurs, whereas MGUS/SMM cases with t(4;14) and t(14;16) are showing a higher progression rate. The recurrent t(14;20) results in ectopic expression of the basic leucine zipper transcription factor MAFB which has an important role in lineage-specific hematopoiesis.
Clinical Applications
- Multiple Myeloma and Plasma Cell Neoplasms (MM)
XL t(14;20) IGH/MAFB DF hybridized to lymphocytes. Two normal interphases are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two greenorange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.
- Boersma-Vreugdenhil et al (2004) Brit J Haem 126:355-363
- Ross et al (2010) Haematologica 95:1221-1225
- Rajan and Rajkumar (2015) Blood Cancer J 5:e365
IVDR Certification
MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.
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