Past event in Netherlands from Mar 19 to Mar 21, 2025
XL BCR/ABL1 plus
Translocation/Dual Fusion Probe
- Order Number
- D-5052-100-OG
- Package Size
- 100 µl (10 Tests)
- Regulatory Status
- IVDR
IVDR Certification
This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.
Please use the switch to change to the IVDD product.
IVDDIVDRDiscover all IVDR-certified productsDownload Instructions For Use (IFU)
Until further notice, we will continue to provide IVDD products in various countries.
As part of our phased rollout, the IVDR-certified probes are now available in Austria, Belgium, Croatia, Cyprus, Estonia, France, Germany, Iceland, Italy, Liechtenstein, Luxembourg, Malta, Netherlands, Slovenia, and Switzerland, with the list of countries continuously expanding.
The XL BCR/ABL1 plus dual-fusion probe is a qualitative, non-automated test for the detection of BCR::ABL1-rearrangements, t(9;22)(q34.1;q11.2) by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and chronic myeloid leukemia and myeloproliferative neoplasms (CML/MPN). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL BCR/ABL1 plus dual-fusion probe consists of an orange-labeled probe hybridizing to the ABL1 gene region at 9q34.1 and a green-labeled probe hybridizing to the BCR gene region at 22q11.2.
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.
XL BCR/ABL1 plus hybridized to bone marrow cells. Two interphase cells with two fusion signals and separated orange and green signals each are shown, indicating a BCR::ABL1 translocation.
Normal Cell:
Two green (2G) and two orange signals (2O).
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 respective loci.
Tumour Genetics Symposium 2025
Upcoming Event in Germany from May 8 to May 10, 2025
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European Cytogenetics Conference
Upcoming Event in Belgium from Jun 29 to Jul 1, 2025
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