Past event in Netherlands from Mar 19 to Mar 21, 2025
XL DLEU/LAMP/12cen
Deletion/Enumeration Probe
- Order Number
- D-5055-100-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 DLEU/LAMP/12cen probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 12 and deletions of the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 by fluorescence in situ hybridization (FISH). The LAMP1 gene region at 13q34 is included as a reference. 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) 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 and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL DLEU/LAMP/12cen probe consists of a green-labeled probe hybridizing to the centromere of chromosome 12, an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and an aqua-labeled probe hybridizing to the LAMP1 gene region at 13q34.
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 DLEU/LAMP/12cen hybridized to bone marrow cells. Three interphases are shown of which one shows a normal signal pattern of 2 orange, 2 green, and 2 blue signals, one nucleus shows a hemizygous, and a third one a homozygous deletion of DLEU (orange).
Normal Cell:
Two Blue (2B), two green (2G) and two orange (2O) signals.
Aberrant Cell:
Two blue (2B) two orange (2O) and three green (3G) signals resulting from a gain of the green labeled chromosome.
Aberrant Cell:
Two blue (2B), two green (2G) and one orange (1O) signal resulting from loss of one orange signal.
Aberrant Cell:
Two blue (2B), two green (2G) and no orange (no O) signals resulting from homozygous deletion of the locus covered by the orange probe.
Tumour Genetics Symposium 2025
Upcoming Event in Germany from May 8 to May 10, 2025
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European Cytogenetics Conference
Upcoming Event in Belgium from Jun 29 to Jul 1, 2025
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