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;18) IGH/BCL2 DF
Translocation/Dual Fusion Probe
- Order Number
- D-5113-100-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;18) IGH/BCL2 DF consists of a green-labeled probe hybridizing to the IGH gene region at 14q32.3 and an orange-labeled probe hybridizing to the BCL2 gene region at 18q21.3.
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.
Rearrangements of the immunoglobulin heavy chain (IGH) gene locus are present in about 50% of all non-Hodgkin lymphomas (NHL) including follicular lymphomas (FL) and diffuse large B-cell lymphomas (DLBCL). FL is the most common indolent form of NHL and accounts for about 20-30% of all lymphoid tumors. The reciprocal translocation t(14;18)(q32;q21) can be detected in about 85% of FL patients and in up to 35% of patients with DLBCL. t(14;18) juxtaposes BCL2 to transcriptional enhancers in the IGH locus and results in overexpression of the BCL-2 protein in neoplastic follicles. BCL2 is involved in the regulation of programmed cell death and shows anti-apoptotic characteristics. Overexpression of BCL2 leads to a high number of B-cells having a prolonged lifespan in germinal centers. This increases the chance to acquire additional chromosomal alterations required for the neoplastic transformation of B-cells.
Clinical Applications
- Non-Hodgkin Lymphomas (NHL)
XL t(14;18) IGH/BCL2 DF hybridized to lymphocytes. One normal interphase and metaphase 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.
- Bernicot et al (2005) Anticancer Res 25:3179-3182
- Ott and Rosenwald (2008) Haemotologica 93:1773-1776
- Freedman (2014) Am J Hematol 89:429-436
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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