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 MECOM 3q26
Break Apart Probe
- Order Number
- D-5059-100-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 MECOM 3q26 break-apart probe is a qualitative, non-automated test for the detection of MECOM-rearrangements at 3q26.2 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 myeloid 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 MECOM 3q26 break-apart probe consists of an orange-labeled probe hybridizing proximal to the MECOM gene region at 3q26.2 and a green-labeled probe hybridizing distal to the MECOM gene region also spanning a distal part of the gene region at 3q26.2.
XL MECOM 3q26 hybridized to lymphocytes. One normal metaphase and one normal interphase are shown.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.
Aberrant Cell (typical results):
Two green-orange colocalization/fusion signals (2GO) and one separate usually small green (1G) signal indicating a variant chromosome break at a more distal region of the locus covered by the green probe.
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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