MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
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 IGH BA break-apart probe consists of an orange-labeled probe partly covering the constant region of the IGH locus at 14q32.3 and a green-labeled probe hybridizing to the variable distal region of the IGH locus at 14q32.3.
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):
One green-orange colocalization/fusion signal (1GO) resulting from the loss of one green signal and one orange signal.
Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one green (1G) signal resulting from the loss of one orange signal.
Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one orange (1O) signal resulting from the loss of one green signal.
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.