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 4q12
Translocation/Deletion Probe
- Order Number
- D-5063-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 044
- 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 4q12 probe is a qualitative, non-automated test for the detection of deletions of the CHIC2 gene region at 4q12 and breaks in PDGFRA at 4q12 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 chronic myelomonocytic leukemia (CMML), myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions (MLN-TK). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL 4q12 probe consists of a green-labeled probe hybridizing proximal to the FIP1L1 gene region at 4q12, an orange-labeled probe hybridizing to the CHIC2 gene region at 4q12 and an aqua-labeled probe hybridizing to the PDGFRA gene region at 4q12.
XL 4q12 hybridized to lymphocytes. Two normal interphases are shown with two blue-green-orange fusion signals each.
Normal Cell:
Two green-orange-blue colocalization/fusion signals
(2BGO).
Aberrant Cell (typical results):
One blue-green-orange colocalization/fusion signal (1BGO) and one blue-green colocalization/fusion (1BG) resulting from loss of one orange signal.
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1BGO), one green-orange colocalization/fusion (1GO) and one separate blue (1B) signal resulting
from a chromosome break in the respective locus.
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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