MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL MYC BA triple-color
Break Apart Probe - Triple Color
- Order Number
- D-6030-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 088
- 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 MYC BA triple-color consists of an orange-labeled probe hybridizing proximal to the MYC gene region at 8q24.21, an aqua-labeled probe hybridizing 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 BA Triple-color probe is designed as a break apart probe with three probes juxtaposed and differentially labeled. In cases with 8q24 rearrangment, the co-localization patterns of orange-blue versus green-blue allows to distinguish different breakpoints in MYC translocations which can be an aid in diagnosis.
Clinical Applications
- Non-Hodgkin Lymphomas (NHL)
- Solid Tumors (Solid Tumors)
Normal Cell:
Two green-orange-blue colocalization/fusion signals (2GOB).
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one green-blue colocalization/fusion (1GB) and one separate orange (1O) signal resulting from a chromosome break in the respective locus.
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one one separate green (1G) and one orange-blue colocalization/fusion (1OB) signal resulting from a chromosome break in the respective locus.
- Hummel et al (2006) N Engl J Med 354:2419-2430
- Einerson et al (2006) Leukemia 20:1790-1799
- Bertrand et al (2007) Leukemia 21:515-523
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.