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 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 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.
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.
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.
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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