Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XL PDGFRA BA
Break Apart Probe
- Order Number
- D-5137-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 044
- 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 PDGFRA BA consists of a green-labeled probe hybridizing proximal to the PDGFRA gene region at 4q12 and an orange-labeled probe hybridizing distal to the PDGFRA gene region at 4q12.
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
- Chronic Eosinophilic Leukemia (CEL)
- Acute Myelogenous Leukemia (AML)
- Acute Lymphoblastic Leukemia (ALL)
XL PDGFRA BA hybridized to bone marrow cells, one aberrant cell is shown. The expected normal signal pattern of XL PDGFRA BA is two green-orange colocalization/fusion signals representing the two normal PDGFRA loci. Cells with breakaparts typically have one normal green-orange colocalization/fusion signal plus one orange and one green signal clearly separate from one another.
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 orange (1O) signal resulting from the loss of one green signal.
- Cools et al (2003) N Engl J Med 348:1201-1214
- Pardanani et al (2003) Blood 102:3093-3096
- Swerdlow et al (2017) WHO classification of tumors of haematopoietic and lymphoid tissues (revised 4th edition)
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.
