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/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 large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
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 are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.
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
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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