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 7q22/7q36
Deletion Probe
- Order Number
- D-5043-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 077
- 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 7q22/7q36 consists of an orange-labeled probe hybridizing to the KMT2E gene region at 7q22, a green-labeled probe hybridizing to the CUL1/EZH2 gene region at 7q36 and an aqua-labeled probe hybridizing to the centromere of chromosome 7.
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
- Myelodysplastic Syndrome (MDS)
- Acute Myelogenous Leukemia (AML)
XL 7q22/7q36 hybridized to lymphocytes. Two normal interphases are shown.
Normal Cell:
Two Blue (2B), two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G), one orange (1O) and 2 blue (2B) indicating the deletion of a 7q22 locus or one green (1G), two orange (2O), and 2 blue (2B) signals, indicating the deletion of a 7q36 locus.
Aberrant Cell (typical results):
Two blue (2B), one green (1G) and one orange (1O) signal resulting from the loss of one green and one orange signal.
Aberrant Cell (typical results):
One blue (1B), one green (1G) and one orange (1O) signal resulting from the loss of one chromosome.
- Le Beau et al (1996) Blood 88:1930-1935
- Emerling et al (2002) Oncogene 21:4849-4854
- De Weer et al (2010) PLoS One 13:e8676
Package Insert (EN)Package Insert (IT)Performance Data (English)Probes Catalog
Certificate of Analysis (CoA)
or go to CoA DatabaseIVDR 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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