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
- IVDR
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.
The XL t(3;3) GATA2/MECOM DF dual-fusion probe is a qualitative, non-automated test for the detection of GATA2::MECOM-rearrangements, inv(3)(q21q26.2)/t(3;3)(q21;q26.2) by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute myeloid leukemia (AML), chronic myelogenous leukemia (CML) and myelodysplastic neoplasms (MDS). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL t(3;3) GATA2/MECOM DF dual-fusion probe 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.
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.
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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