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XL P2RY8 del
Deletion Probe
- Order Number
- D-5150-100-OG
- Package Size
- 100 µl (10 Tests)
- 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 P2RY8 del probe is a qualitative, non-automated test for the detection of deletions of the P2RY8 gene region at Xp22.33 and Yp11.32 by fluorescence in situ hybridization (FISH). 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). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL P2RY8 del probe consists of an orange-labeled probe hybridizing to P2RY8 and distal to the P2RY8 gene region at Xp22.33 and Yp11.32 and a green-labeled probe hybridizing proximal to the P2RY8 gene region at Xp22.33 and Yp11.32.
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 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.
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