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 ROS1-GOPC BA
Break Apart Probe
- Order Number
- D-6029-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 066
- 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 ROS1-GOPC BA break-apart probe is a qualitative, non-automated test for the detection of ROS1-rearrangements at 6q22.1 by fluorescence in situ hybridization (FISH). The probe design also allows detection of interstitial deletions at 6q22.1 between ROS1 and GOPC. The product is intended as a diagnostic aid. The test population consists of patients with confirmed or suspected solid tumors, e.g.lung cancer. Hybridization is to be performed on sections of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens.
The XL ROS1-GOPC BA break-apart probe consists of a green-labeled probe hybridizing proximal to the ROS1 gene region at 6q22.1 and an orange-labeled probe hybridizing distal to the ROS1 gene region and proximal to GOPC at 6q22.1.
XL ROS1-GOPC BA hybridized to the U-138 cell line. Several interphase nuclei show the expected fusion pattern, while one cell to the left is showing a homozygous deletion of the orange 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.
Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one green (1G) signal resulting from the loss of one orange 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.
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