MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL t(7;12) MNX1/ETV6
Translocation/Dual Fusion Probe
- Order Number
- D-5101-100-OG
- Package Size
- 100 µl (10 Tests)
- 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 t(7;12) MNX1/ETV6 consists of an orange-labeled probe hybridizing to the MNX1 gene region at 7q36 and a green-labeled probe hybridizing to the ETV6 gene region at 12p13.2.
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.
Several recurrent balanced translocations and inversions, and their variants, are recognized in the WHO category acute myeloid leukemia (AML) with recurrent genetic abnormalities. Furthermore, several cytogenetic abnormalities are considered sufficient to establish the WHO diagnosis of AML with myelodysplasia-related features if 20% or more blood or marrow blasts are present.
The t(7;12)(q36;p13) translocation is a recurrent chromosome abnormality which involves the ETV6 gene on chromosome 12 and has been identified in 20–30% of infant patients with AML. The detection of t(7;12) rearrangements relies on the use of fluorescence in situ hybridization (FISH) because this translocation is hardly visible by chromosome banding methods. The clinical outcome of t(7;12) patients is believed to be poor, therefore an early and accurate diagnosis is important in the clinical management and treatment.
Clinical Applications
- Acute Myelogenous Leukemia (AML)
Normal Cell:
Two green (2G) and two orange signals (2O).
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange fusion (2GO) (adjacent green and orange) signals.
- Ballabio et al (2009) Leukemia 23:1179-1182
- Naiel et al (2013) Cancers 5:281-295
- Owokaet al (2015) Hematol Leuk 3:1-4
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.