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(3;3) GATA2/MECOM DF
Translocation/Dual Fusion Probe
- Order Number
- D-5124-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 033
- 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(3;3) GATA2/MECOM DF consists of a green-labeled probe hybridizing to the GATA2 gene region at 3q21 and an orange-labeled probe hybridizing to the MECOM gene region at 3q26.2.
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.
The chromosomal aberrations inv(3)(q21q26.2) and t(3;3)(q21;q26.2) characterize a distinct entity within patients with acute myeloid leukemia (AML). Their incidence in AML is about 1-2.5% and patients have an unfavorable prognosis and low response to chemotherapy.
Inv(3)/t(3;3) juxtapose the GATA2 enhancer with the MECOM locus which results in overexpression of EVI1. The EVI1 gene is located in 3q26 and is involved in hematopoietic stem cell maintenance. EVI1 is, together with MDS1, located in the ´MDS1 and EVI1 complex locus´ (MECOM) and is the major player in this subtype of AML.
Furthermore, structural rearrangements caused by inv(3)/t(3;3) result in reduced GATA2 expression which may contribute to the oncogenic potential of this aberration. GATA2 is located in chromosomal region 3q21 and is involved in development and proliferation of hematopoietic stem cells. Several other recurrent 3q26 rearrangements such as t(3;21)(q26;q22), t(3;12)(q26;p13) and t(2;3)(p15-23;q26) are known and many more rearrangements may occur.
Clinical Applications
- Acute Myelogenous Leukemia (AML)
- Myelodysplastic Syndrome (MDS)
XL t(3;3) GATA2/MECOM DF hybridized to lymphocytes. One normal interphase and metaphase are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two greenorange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.
Aberrant Cell (typical results):
Two green (2G) and three orange signals (3O) resulting from a translocation with breakpoints in the orange labeled gene region and another unknown chromosome.
- Gröschel et al (2014) Cell 157:369-381
- De Braekeleer et al (2015) Fut Oncol 11:1675-1686
- Arber et al (2016) Blood 19:2391-2405
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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