MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
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
MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
Discover all IVDR-certified productsXL 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 are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.
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)
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.