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 CBFB/MYH11 plus
Translocation/Dual Fusion Probe
- Order Number
- D-5126-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1616
- 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 CBFB/MYH11 plus consists of a green-labeled probe hybridizing to the MYH11 gene region at 16p13.1 and an orange-labeled probe hybridizing to the CBFB gene region at 16q22.
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 Myelogenous Leukemia (AML)
XL CBFB/MYH11 plus hybridized to bone marrow cells. One aberrant interphases is shown. A partial insertion of MYH11 into CBFB results in two green, one orange and one green/orange colocalization/fusion signal.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from an inversion or reciprocal translocation with breakpoints in the respective loci.
- Fröhling et al (2005) Heamatologica 90:194-199
- Van Obbergh et al (2014) Cancer Genetics 207:231-232
- Zhang et al (2017) Adv in Mod Onc Res 3:12-14
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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