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 CBFB/MYH11 plus
Translocation/Dual Fusion Probe
- Order Number
- D-5126-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1616
- 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 CBFB/MYH11 plus dual-fusion probe is a qualitative, non-automated test for the detection of CBFB::MYH11-rearrangements inv(16)(p13.1q22)/t(16;16)(p13.1;q22) 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). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL CBFB/MYH11 plus dual-fusion probe consists of a green-labeled probe hybridizing to the MYH11 gene region at 16p13.1 and an orange-labeled probe hybridizing to the CBFB gene region at 16q22.
XL CBFB/MYH11 plus hybridized to bone marrow cells. One aberrant interphases is shown. A partial insertion of MYH11 into CBFB results in two green, one orange and one green/orange colocalization/fusion signal.
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 an inversion or reciprocal translocation with breakpoints in the respective loci.
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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