MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
XL ATM/TP53
Deletion Probe
- Order Number
- D-5046-100-OG
- Package Size
- 100 µl (10 Tests)
- 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 large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
XL ATM/TP53 consists of a green-labeled probe hybridizing to the ATM gene region at 11q22.3 and an orange-labeled probe hybridizing to the TP53 gene region at 17p13.
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.
The prognosis and clinical course of chronic lymphocytic leukemia (CLL) are heterogeneous. Conventional banding techniques in CLL are hampered by the low mitotic index of the neoplastic cells. The introduction of interphase cytogenetics using fluorescent in situ hybridization (FISH) has greatly increased the sensitivity of cytogenetic analyses. With FISH, abnormalities can be detected in more than 80% of patients by using a 4-probe panel for the detection of trisomy 12q13-15 and deletions 13q14, 17p13, and 11q22-23. An additional 10% of patients can be shown to carry a 6q21 deletion, 14q32 translocation, and partial trisomy 3q or 8q.
TP53 is a tumor suppressor gene which stops cell division when DNA damage is present. Loss of TP53 at 17p13 is a powerful predictor of resistance to therapy with purine analogues and alkylating agents, and of poor prognosis in CLL. Chromosome 11q22.3-23.1 deletions involving the ataxia telangiectasia mutated (ATM) locus are detected at diagnosis in 15 - 20% of cases of B-cell CLL and are associated with a more aggressive disease.
Clinical Applications
- Chronic Lymphocytic Leukemia (CLL)
XL ATM/TP53 hybridized to bone marrow cells. Four interphases are shown of which two show a normal signal pattern. The two other interphases show aberrant signal patterns with a deletion of ATM in one cell and a deletion of TP53 in the other one.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
One green (1G) and two orange (2O) signal resulting from loss of one green signal.
Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.
- Doehner et al (2000) N Engl J Med 343:1910-1916
- Stilgenbauer et al (2002) Leukemia 16:993-1007
- Gunn at al (2008) J Mol Diagn 10:442-451
Package Insert (EN)Package Insert (IT)Performance Data (English)Probes Catalog
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.
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