Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XL CBFB
Break Apart Probe
- Order Number
- D-5092-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1616
- 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 CBFB consists of an orange-labeled probe hybridizing proximal to the CBFB gene region at 16q21-22 and a green-labeled probe hybridizing distal to the CBFB gene region at 16q22.
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
- Acute Myelogenous Leukemia (AML)
XL CBFB hybridized to bone marrow cells. One metaphase with split signals in one chromosome is shown, indicating a chromosome break in the CBFB locus.
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.
- Doehner et al (2010) Blood 115:453-474
- Froehling et al (2002) J Clin Oncol 20:2480-2485
- Arber et al (2016) Blood 127:2391-2405
Our 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.
