Past 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
- IVDR
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
Please use the switch to change to the IVDD product.
IVDDIVDRDiscover all IVDR-certified productsDownload Instructions For Use (IFU)
Until further notice, we will continue to provide IVDD products in various countries.
As part of our phased rollout, the IVDR-certified probes are now available in Austria, Belgium, Croatia, Cyprus, Estonia, France, Germany, Iceland, Italy, Liechtenstein, Luxembourg, Malta, Netherlands, Slovenia, and Switzerland, with the list of countries continuously expanding.
The XL t(8;14) MYC/IGH DF 8cen dual-fusion probe is a qualitative, non-automated test for the detection of IGH::MYC-rearrangements t(8;14)(q24.21;q32.3) by fluorescence in situ hybridization (FISH). A centromere 8 specific reference is included. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin-lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for ALL and CLL, on methanol/acetic-acid fixed plasma cells for MM and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL t(8;14) MYC/IGH DF 8cen dual-fusion probe 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.
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.
Tumour Genetics Symposium 2025
Upcoming Event in Germany from May 8 to May 10, 2025
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European Cytogenetics Conference
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