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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 FGFR1 break-apart probe consists of a green-labeled probe hybridizing proximal to the FGFR1 gene region at 8p11.2 and an orange-labeled probe hybridizing distal to the FGFR1 gene region at 8p11.2.
XL FGFR1 hybridized to bone marrow cells where a subpopulation with trisomy 8 was observed. One normal interphases is shown and one interphase with three fusion signals.
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.
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.
