MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
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 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.
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.
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.
IVDR Certification
MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.
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