Past event in Netherlands from Mar 19 to Mar 21, 2025
XL MYC BA triple-color
Break Apart Probe - Triple Color
- Order Number
- D-6030-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 088
- 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 MYC BA triple-color break-apart probe is a qualitative, non-automated test for the detection of MYC-rearrangements at 8q24.21 by fluorescence in situ hybridization (FISH). The probe design also allows differentiation of the location of the breakpoint. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected 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 CLL, on methanol/acetic-acid fixed plasma cells for MM and on sections of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL MYC BA triple-color break-apart probe consists of an orange-labeled probe hybridizing proximal to the MYC gene region at 8q24.21, an aqua-labeled probe hybridizing to the MYC gene region at 8q24.21 and a green-labeled probe hybridizing distal to the MYC gene region at 8q24.21.
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 MYC BA triple-color hybridized to lymphocytes. One nucleus shows the normal two green-orange-blue signals, the other nucleus shows a separated green signal indicating a break distal to the MYC gene region.
Normal Cell:
Two green-orange-blue colocalization/fusion signals (2GOB).
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one green-blue colocalization/fusion (1GB) and one separate orange (1O) signal resulting from a chromosome break in the respective locus.
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one one separate green (1G) and one orange-blue colocalization/fusion (1OB) signal resulting from a chromosome break in the respective locus.
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one green-blue colocalization/fusion (1GB) and one orange-blue colocalization/fusion (1OB) signal resulting from a chromosome break in therespective locus.
Tumour Genetics Symposium 2025
Upcoming Event in Germany from May 8 to May 10, 2025
Meet our colleagues in Leipzig, Germany!
European Cytogenetics Conference
Upcoming Event in Belgium from Jun 29 to Jul 1, 2025
Meet our colleagues in Leuven, Belgium!
