Past event in Netherlands from Mar 19 to Mar 21, 2025
XL CCND1
Break Apart Probe
- Order Number
- D-5071-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1111
- 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 CCND1 break-apart probe is a qualitative, non-automated test for the detection of CCND1- and MYEOV-rearrangements at 11q13.3 by fluorescence in situ hybridization (FISH). 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 methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL CCND1 break-apart probe consists of an orange-labeled probe hybridizing proximal to the MYEOV gene region at 11q13.3 and a green-labeled probe hybridizing to CCND1 and distal to the CCND1 gene region at 11q13.3.
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 CCND1 hybridized to lymphocytes. One normal metaphase and two normal interphases are shown.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO),one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.
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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