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XL RARA BA
Break Apart Probe
- Order Number
- D-5087-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1717
- 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.
IVDRIVDDDiscover 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 Australia, Austria, Bangladesh, Belgium, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Iceland, Italy, Jordan, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Nepal, Netherlands, New Zealand, Oman, Palestine, Poland, Slovakia, Slovenia, South Africa, Switzerland, Ukraine, and United Arab Emirates with the list of countries continuously expanding.
Note: Our IVDR-certified XA probes are now available across all EU countries. For more details, please visit the individual product pages.
The XL RARA BA break-apart probe is a qualitative, non-automated test for the detection of RARA-rearrangements at 17q21.2 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 promyelocytic leukemia (APL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL RARA BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the RARA gene region at 17q21.1-21.2 and a green-labeled probe hybridizing distal to the RARA gene region at 17q21.1-21.2.
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 RARA BA hybridized to bone marrow cells. One aberrant interphase with two colocalization/fusion signals and one additional green signal is shown, indicating an insertion of RARA into another chromosome.
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
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 respective locus.
Tumour Genetics Symposium 2025
Past event in Germany from May 8 to May 10, 2025
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European Cytogenetics Conference
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