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 BCL3 BA
Break Apart Probe
- Order Number
- D-5128-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1919
- 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 BCL3 BA consists of an orange-labeled probe hybridizing proximal to the BCL3 gene region at 19q13.3 and a green-labeled probe hybridizing distal to the BCL3 gene region at 19q13.3.
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
- Chronic Lymphocytic Leukemia (CLL)
XL BCL3 BA hybridized to bone marrow cells. One aberrant cell with split signal is shown, indicating a break in the BCL3 locus.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.
- Michaux et al (1996) Genes Chrom Can 15:38-47
- Huh et al (2011) Am J Clin Pathol 135:686-696
- Puiggros et al (2014) Biomed Res Int 2014:Article ID 435983
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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