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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 MYC BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the MYC gene region at 8q24.21 and a green-labeled probe hybridizing distal to the MYC gene region at 8q24.21.
XL MYC BA hybridized to lymphocytes. Separate orange and green signals indicate a split in the MYC gene region.
Normal Cell:
Two green-orange (2GO) 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 relevant locus.
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.
