Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
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 wide range of FISH probes, according to IVDR.
This product remains IVDD-certified until further notice.
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 for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.
Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.
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)
XL MYC BA triple-color hybridized to lymphocytes. One nucleus shows the normal two green-orange-blue signals, the other nucleus shows a separated green signal indicating a break distal to the MYC gene region.
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
Package Insert (EN)Package Insert (IT)Performance Data (English)Probes Catalog
Certificate of Analysis (CoA)
or go to CoA DatabaseOur Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Feb 1, 2025: Rollout of IVDR-certified XCyting FISH Probes!
The first phase of this rollout includes the following countries: Austria, Cyprus, Estonia, Germany, Iceland and The Netherlands. More countries will be supplied over time.
