Upcoming 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
- IVDD
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
XL ROS1-GOPC BA 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 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.
Clinical Applications
- Solid Tumors (Solid Tumors)
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.
- Charest et al (2003) Genes Chrom Cancer 37:58-71
- Takeuchi et al (2011) Nat Med 18:378-381
- Bergethon et al (2012) J Clin Oncol 30:863-870
Package Insert (EN)Package Insert (IT)Performance Data (English)Probes Catalog
Certificate of Analysis (CoA)
or go to CoA DatabaseOur Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Feb 1, 2025: Rollout of IVDR-certified XCyting FISH Probes!
The first phase of this rollout includes the following countries: Austria, Cyprus, Estonia, Germany, Iceland and The Netherlands. More countries will be supplied over time.
