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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 KMT2A BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the KMT2A gene region at 11q23.3 extending into the gene up to intron 24 and a green-labeled probe hybridizing distal to the KMT2A gene region at 11q23.3 extending into the gene up to intron 20 and thus overlapping each other for 3.4kb (GRCh37/hg19).
XL KMT2A BA hybridized to bone marrow cells, one aberrant cell is shown. A cryptic insertion of KMT2A is observed generating a signal pattern of two orange-green colocalization/fusion signals and one additional orange signal.
Normal Cell:
Two green-orange (2GO) colocalization/fusion signals.
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. Translocations with breakpoints within the KMT2A breakpoint cluster region result in a small orange split signal remaining with the separated green signal. The residual orange signal is significantly smaller than the separated orange signal and might even be invisible.
Aberrant Cell (typical results):
Two green-orange colocalization/fusion signals (2GO) and one separate usually small orange (1O) signal indicating an insertion of the respective genomic region to an unknown chromosome.
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.
The IVDR is effective and our probes stay the same! A large segment of our portfolio is already IVDR-certified. Our priority is to give you a smooth transition into the IVDR era.
We hope you had a chance to meet us.
