Past event in Netherlands from Mar 19 to Mar 21, 2025
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 for in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
Please use the switch to change to the IVDD product.
IVDDIVDRDiscover all IVDR-certified productsDownload Instructions For Use (IFU)
Until further notice, we will continue to provide IVDD products in various countries.
As part of our phased rollout, the IVDR-certified probes are now available in Austria, Belgium, Croatia, Cyprus, Estonia, France, Germany, Iceland, Italy, Liechtenstein, Luxembourg, Malta, Netherlands, Slovenia, and Switzerland, with the list of countries continuously expanding.
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.
Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.
Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.
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.
Tumour Genetics Symposium 2025
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