Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XL CDKN2A/9q22
Deletion Probe
- Order Number
- D-5118-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 099
- Regulatory Status
- IVDD
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
XL CDKN2A/9q22 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 CENPP gene region at 9q22.3.
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.
Clinical Applications
- Acute Lymphoblastic Leukemia (ALL)
XL CDKN2A/9q22 hybridized to lymphocytes. Two normal interphases are shown.
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.
- Novara et al (2009) Human Genet 126:511-520
- Sulong et al (2009) Blood 113:100-107
- Girardi et al (2017) Blood 129:1113-1123
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Feb 1, 2025: Rollout of IVDR-certified XCyting FISH Probes!
The first phase of this rollout includes the following countries: Austria, Cyprus, Estonia, Germany, Iceland and The Netherlands. More countries will be supplied over time.
