MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL Iso(17q)
Deletion/Isochromosome Probe
- Order Number
- D-5048-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1717
- 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 Iso(17q) consists of a green-labeled probe hybridizing to the TP53 gene region at 17p13 and an orange-labeled probe hybridizing to the MPO gene region at 17q22.
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.
An isochromosome of the long arm of chromosome 17, i(17q), is the most frequent genetic abnormality observed during the disease progression of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). The breakpoints are located in the short arm of chromosome 17 within the Smith-Magenis critical region at 17p11. In neuroblastoma and other hematologic malignancies, amplification of 17q is a significant predictive factor for adverse outcome.
Isochromosome 17q, or i(17q), is ocurring in primitive neuroectodermal tumor/medulloblastoma (50%), chronic myeloid leukemia (CML), acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS).
Clinical Applications
- Chronic Myelogenous Leukemia (CML)
- Myelodysplastic Syndrome (MDS)
- Acute Lymphoblastic Leukemia (ALL)
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical result):
One green (1G), three orange (3O) signals, indicating the presence of i(17q).
Aberrant Cell (typical results):
Two green (2G), three orange (3O) signals, indicating a gain of 17q.
Aberrant Cells (typical results):
One green (1G) and two orange (2O) signals, indicating a deletion of the TP53 locus.
- Fioretos et al (1999) Blood 94:225-232
- Barbouti et al (2004) Am J Hum Genet 74:1-10
- Carvalho et al (2008) Genome Res 18:1724-1732
Certificate of Analysis (CoA)
or go to CoA DatabaseIVDR 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.