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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 wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
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 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.
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
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.
