Past event in Netherlands from Mar 19 to Mar 21, 2025
XL CDKN2A
Deletion Probe
- Order Number
- D-5053-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 099
- 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 CDKN2A probe is a qualitative, non-automated test for the detection of deletions of the CDKN2A/CDKN2B gene region at 9p21 by fluorescence in situ hybridization (FISH). A centromere 9 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) and non-Hodgkin-lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from peripheral blood or bone marrow for ALL and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL CDKN2A probe consists of an orange-labeled probe hybridizing to the CDKN2A (p16)/CDKN2B (p15) gene region at 9p21 and a green-labeled probe hybridizing to the centromere of chromosome 9.
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 CDKN2A hybridized to bone marrow cells. Two normal cells and several cells with two green signals are shown indicating a homozygous deletion of the CDKN2A.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.
Aberrant Cell (typical results):
Two green (2G) and no orange
(no O) signal 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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