Upcoming Event in Netherlands from Mar 19 to Mar 21, 2025
XL BCR/ABL1/ASS
Translocation/Dual Fusion Probe
- Order Number
- D-5082-100-TC
- Package Size
- 100 µl (10 Tests)
- 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 BCR/ABL1/ASS consists of an aqua-labeled probe hybridizing to the ASS1 gene region at 9q34.1, 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.
Chronic myelogenous leukemia (CML) is genetically characterized by the presence of the reciprocal translocation t(9;22)(q34;q11), resulting in a BCR/ABL1 gene fusion on the derivative chromosome 22, called the Philadelphia (Ph) chromosome. The same translocation can also be found in acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) with some variation in the breakpoint region. Glivec® (imatinib mesylate) treatment targeting the BCR/ABL1 active tyrosine kinase has become a major drug in treating CML, gastrointestinal stromal tumors, and other cancers.
Deletions at the t(9;22) breakpoint regions, found in 5% of CML patients with a Ph translocation, have been associated with resistance to treatment in patients receiving tyrosine kinase inhibitors.
Clinical Applications
- Chronic Myelogenous Leukemia and Myeloproliferative Neoplasms (CML/MPN)
- Acute Lymphoblastic Leukemia (ALL)
- Acute Myelogenous Leukemia (AML)
XL BCR/ABL1/ASS hybridized to lymphocytes. One normal metaphase is shown.
Normal Cell:
Two blue-orange (2BO) fusion signals and two separate green signals (2G).
Aberrant Cell (typical results):
One blue-orange colocalization/fusion signal (1BO), one green (1G), one blue-green-orange colocalization/fusion signal (1BGO) and one greenorange colocalization/fusion signal (1GO).
Aberrant Cell (typical results):
One blue-orange (1BO), two green (2G), and one green-orange (1GO) fusion signal, indicating a deletion at 9q34 in addition to a t(9;22).
- Dewald et al (1998) Blood 91:3357-3365
- DeMelo et al (2008) Canc Genet Cytogenet 182:111-115
- Luatti et al (2012) Blood 120:761-767
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.
