MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL P2RY8 del
Deletion Probe
- Order Number
- D-5150-100-OG
- Package Size
- 100 µl (10 Tests)
- 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 P2RY8 del detects deletions in the short arm of chromosome X and Y at Xp22.33 and Yp11.32, respectively. The orange labeled probe spans P2RY8 and extends distally, the green labeled probe covers the 5´end of P2RY8 and extends proximally.
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 P2RY8 del hybridized to bone marrow cells. One aberrant cell of a patient with a gonosomal constellation of XXY is shown. The two orange-green fusion signals represent the two unaffected CRLF2P2RY8 loci. A deletion between CRLF2 and P2RY8 is identified by a separate green signal. This signal pattern gives strong indication that the P2RY8-CRLF2 gene-fusion is present.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one green (1G) signal resulting from the loss of one orange signal.
- Mullighan et al (2009) Nat Genet 41:1243-1246
- Russell et al (2017) Genes Chromosomes Cancer 56:363-372
- Tasian et al (2017) Blood 130:2064-2072
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.