Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XL t(8;14) MYC/IGH DF 8cen
Translocation/Dual Fusion Probe
- Order Number
- D-5125-100-TC
- 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(8;14) MYC/IGH DF 8cen consists of an aqua-labeled probe hybridizing to the centromere of chromosome 8, an orange-labeled probe hybridizing to the MYC gene region at 8q24.21 and a green-labeled probe hybridizing to the IGH gene region at 14q32.3.
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.
Clinical Applications
- Non-Hodgkin Lymphomas (NHL)
- Acute Lymphoblastic Leukemia (ALL)
XL t(8;14) MYC/IGH DF 8cen hybridized to lymphocytes. One normal interphase and metaphase are shown.
Normal Cell:
Two blue (2B), two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two blue (2B), one green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.
Aberrant Cell (typical results):
Three blue (3B), two green (2G), and three orange (3O) signals resulting from a gain of the orange/blue labeled chromosome.
Aberrant Cell (typical results):
Two blue (2B), two green (2G), and three orange (3O) signals resulting from a translocation between the orange labeled and an unknown chromosome.
- Siebert et al (1998) Blood 91:984-990
- Boerma et al (2009) Leukemia 23:225-234
- Nguyen et al (2017) Genes 8:1-23
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.
