MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL t(11;14) MYEOV/IGH DF
Translocation/Dual Fusion Probe
- Order Number
- D-5111-100-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(11;14) MYEOV/IGH DF consists of an orange-labeled probe hybridizing to the MYEOV/CCND1 gene region at 11q13.3 and a green-labeled probe hybridizing to the IGH gene region at 14q32.3.
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.
Mantle cell lymphoma (MCL) is a B-cell non-Hodgkin lymphoma (NHL) with an aggressive clinical course. It is genetically characterized by t(11;14)(q13;q32) which is present in about 95% of MCL patients. By lower frequency, t(11;14) is also detectable in B-cell prolymphocytic leukemia, myelomas and chronic lymphocytic leukemia. The translocation induces overexpression of CCND1 which is normally not detected in B lymphocytes. CCND1 is a major player in cell cycle regulation and involved in the G1/S-phase transition. The oncogenic potential of CCND1 overexpression is related to its role in the cell cycle but also to other, non-cell cycle-related mechanisms such as increased genomic instability and cell survival. t(11;14) is considered as a primary event, often followed by secondary chromosome alterations.
In multiple myeloma (MM), t(11;14) is the most common translocation, detectable by FISH in about 15-20% of all MM patients. Conventional cytogenetics has a much lower sensitivity, detecting t(11;14) in about 5% of MM patients. MM t(11;14) patients do have a relatively favorable outcome compared to other recurrent IGH translocations.
Clinical Applications
- Non-Hodgkin Lymphomas (NHL)
- Multiple Myeloma and Plasma Cell Neoplasms (MM)
- Chronic Lymphocytic Leukemia (CLL)
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the relevant loci.
- Fonesca et al (2002) Blood 99:3735-3741
- Bentz et al (2004) Canc Cytopath 102:124-131
- Jares et al (2012) J Clin Invest 122:3416-3423
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.