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 DC
Translocation/Deletion Probe
- Order Number
- D-5123-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 044
- 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 4q12 DC 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 another green-labeled probe hybridizing to the PDGFRA gene region at 4q12.
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
- Myeloproliferative Neoplasm (MPN)
XL 4q12 DC hybridized to lymphocytes. Two normal interphases and one metaphase are shown.
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.
Aberrant Cell (typical results):
One green (1G) and two green-orange colocalization/fusion signals (2GO) signals resulting from a translocation between the green labeled PDGFRA gene region and an unknown chromosome.
- Cools et al (2003) N Engl J Med 348:1201-1214
- Pardanani et al (2003) Blood 102:3093-3096
- Swerdlow et al (2017) WHO classification of tumors of haematopoietic and lymphoid tissues (revised 4th edition)
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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