Break Apart Probe

Order Number
Package Size
100 µl (10 Tests)
Regulatory Status

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.

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Product Description


XL RARA BA 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 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.

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Clinical Details

Acute promyelocytic leukemia (APL) is considered as a subtype of acute myeloid leukemia (AML) and accounts for about 5-8% of all AML cases. The most frequent aberration in APL is t(15;17) which results in the formation of the promyelocytic leukemia (PML) - retinoic acid receptor alpha (RARA) fusion gene (PML-RARA). Around 98% of all APL cases are characterized by PML-RARA, whereas translocations affecting RARA and other genes have been identified in only 1-2% of APL cases. Known fusion genes are ZBTB16-RARA, NPM1-RARA, NUMA1-RARA, STAT5B-RARA, PRKAR1A-RARA, BCOR-RARA and FIP1L1-RARA. ZBTB16-RARA comprises about 0.8% of all APL cases, the other rare fusions occur with lower frequency. Cryptic rearrangements resulting in the PML-RARA fusion gene are observed regularly, but also insertions of RARA into other locations have been found in a minority of APL cases.
RARA is a nuclear hormone receptor which forms heterodimers with the retinoid X receptor alpha and is involved in the regulation of promyelocyte differentiation. RARA fusion genes interfere with myeloid differentiation and contribute to the development of APL. The majority of APL patients are responsive to therapeutic doses of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) associated with chemotherapeutic drug regimen. Patients with ZBTB16-RARA or STAT5B-RARA fusions are resistant to ATRA and ATO.
The FISH break apart assay is a valuable tool for the detection of RARA rearrangements independent of the translocation partner.

Clinical Applications

  • Acute Myelogenous Leukemia (AML)
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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.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green-orange colocalization/fusion signals (2GO).

Expected Pattern 2

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.

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  • Grimwade et al (2000) Blood 15:1297-1308
  • Schoch et al (2002) Hematol J 3:259-263
  • Adams and Nassiri (2015) Arch Pathol Lab Med 139:1308-1313



IVDR 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.

IVDR Certification