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 CRLF2 BA
Break Apart Probe
- Order Number
- D-5130-100-OG
- Package Size
- 100 µl (10 Tests)
- 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 CRLF2 BA consists of an orange-labeled probe hybridizing proximal to the CRLF2 gene region at Xp22.33 and Yp11.32 and a green-labeled probe hybridizing distal to the CRLF2 gene region at Xp22.33 and Yp11.32.
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
- Acute Lymphoblastic Leukemia (ALL)
XL CRLF2 BA hybridized to bone marrow cells. Two aberrant cells of a patient with a gonosomal constellation of XXY are shown. Two normal CRLF2 loci were observed indicated by two fusion signals. The separate green signal indicates a deletion proximal of CRLF2.
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.
Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one green (1G) signal resulting from the loss of one orange signal.
- Roll and Reuther (2010) Cancer Res 70:7347-7352
- Yoda et al (2010) Proc Natl Acad Sci 107:252-257
- Tasian et al (2017) Blood 130:2064-2072
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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