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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 MYC BA consists of an orange-labeled probe hybridizing proximal to the MYC gene region at 8q24.21 and a green-labeled probe hybridizing distal to the MYC gene region at 8q24.21.
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.
Translocations involving MYC are observed in diffuse large-B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and other lymphomas. In Burkitt Lymphoma, the MYC gene, located at 8q24, is activated by a translocation next to an immunoglobulin constant gene. Most frequently, MYC is positioned near the immunoglobulin heavy-chain (IGH) constant region on chromosome 14q32. However, in some tumors MYC can also be positioned near the light-chain region on chromosome 2p11 (IGK) or 22q11 (IGL). In addtion, other translocation partners have been identified (e.g. BCL11A, PAX5, ZCCHC7).
The XL MYC probe is designed as a break apart probe with two probes juxtaposed and differentially labeled. The proximal and distal regions are sufficiently large to achieve intense signals also on paraffin-embedded tissue sections. The wide gap between the orange and green part of this probe allows for the detection of the t(2;8) translocation as well as t(8;14) and t(8;22).
XL MYC BA hybridized to lymphocytes. Separate orange and green signals indicate a split in the MYC gene region.
Normal Cell:
Two green-orange (2GO) fusion signals.
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 relevant locus.
Certificate of Analysis (CoA)
or go to CoA DatabaseMetaSystems 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.
The IVDR is effective and our probes stay the same! A large segment of our portfolio is already IVDR-certified. Our priority is to give you a smooth transition into the IVDR era.
We hope you had a chance to meet us.
