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 t(8;14) MYC/IGH DF 8cen
Translocation/Dual Fusion Probe
- Order Number
- D-5125-100-TC
- 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 t(8;14) MYC/IGH DF 8cen consists of an aqua-labeled probe hybridizing to the centromere of chromosome 8, an orange-labeled probe hybridizing to the MYC gene region at 8q24.21 and a green-labeled probe hybridizing to the IGH gene region at 14q32.3.
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
- Non-Hodgkin Lymphomas (NHL)
- Acute Lymphoblastic Leukemia (ALL)
XL t(8;14) MYC/IGH DF 8cen hybridized to lymphocytes. One normal interphase and metaphase are shown.
Normal Cell:
Two blue (2B), two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two blue (2B), one green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.
Aberrant Cell (typical results):
Three blue (3B), two green (2G), and three orange (3O) signals resulting from a gain of the orange/blue labeled chromosome.
Aberrant Cell (typical results):
Two blue (2B), two green (2G), and three orange (3O) signals resulting from a translocation between the orange labeled and an unknown chromosome.
- Siebert et al (1998) Blood 91:984-990
- Boerma et al (2009) Leukemia 23:225-234
- Nguyen et al (2017) Genes 8:1-23
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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