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(6;9) DEK/NUP214
Translocation/Dual Fusion Probe
- Order Number
- D-5097-100-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 t(6;9) DEK/NUP214 consists of a green-labeled probe hybridizing to the DEK gene region at 6p22.3 and an orange-labeled probe hybridizing to the NUP214 gene region at 9q34.1.
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.
Several recurrent balanced translocations and inversions, and their variants, are recognized in the WHO category acute myelogenous leukemia (AML) with recurrent genetic abnormalities. Three new cytogenetically defined entities were recently incorporated: AML with t(6;9)(p23;q34) DEK/NUP214; AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2) RPN1/EVI1 and AML (megakaryoblastic) with t(1;22)(p13;q13) RBM15/MKL1, a rare leukemia most commonly occurring in infants.
The t(6;9)(p23;q34) DEK/NUP214 fusion occurs with an incidence of 1–5% in adult patients with AML. This translocation tends to occur in younger adults and is associated with an unfavorable prognosis at diagnosis. Although the t(6;9) is usually the sole cytogenetic aberration at diagnosis, additional karyotypic abnormalities are frequently identified during disease progression.
Clinical Applications
- Acute Myelogenous Leukemia (AML)
XL t(6;9) DEK/NUP214 hybridized to lymphocytes. One normal metaphase is shown.
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 a reciprocal translocation between the respective loci.
- Shearer et al (2005) Leukemia 19:126-131
- Doehner et al (2010) Blood 115:453-474
- Sandahl et al (2014) Haematologica 99:865-872
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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