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AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion

Fda cleared
Area of Interest
Catalogue Numbers
USA-LPH 026 (10 tests)

Probe Specification

  • ETO, 8q21.3, FITC Green
  • AML1, 21q22.1, Texas Red

The AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit consists of a 156kb probe labeled in Texas Red, centromeric to the AML1 (RUNX1) gene, including the CLIC6 gene; a 169kb probe labelled in Texas red, telomeric to AML1 (RUNX1) gene, extending beyond the marker D21S1921; and two (151kb and 194kb) probes, labeled inn FITC green, on either side of the ETO (RUNX1T1) gene.

Probe Information

AML with a RUNX1-RUNX1T1 fusion resulting from a t(8;21)(q22;q22) translocation is a recognized disease entity according to the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia1. The translocation is commonly observed in patients with AML FAB type M2, most commonly in children and young adults2 and is a good prognostic indicator3,4,5. The t(8;21) breakpoint mainly occurs in the intron between exons 5 and 6, just before the transactivation domain. The fusion protein created contains the DNA-binding domain of RUNX1 fused to the transcription factor RUNX1T12. In addition to the reciprocal t(8;21) translocation creating the RUNX1-RUNX1T1 fusion, variant translocations have also been reported. These variant rearrangements may be cryptic and easily overlooked by G-banding; however, FISH can indicate the presence of such rearrangements2.

Recommended Protocol

Intended Use

The AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect rearrangement involving the AML1 (RUNX1) region on chromosome 21 at location 21q22.1 and the ETO (RUNX1T1) region on chromosome 8 at location 8q21.3 in fixed bone marrow specimens from patients with acute myeloid leukemia (AML). The test is indicated for characterization of patient specimens consistent with World Health Organization (WHO) guidelines for Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th Edition) and in conjunction with other clinicopathological criteria. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. The test is not intended for use as a stand-alone diagnostic, disease screening, or as a companion diagnostic.

Limitations of the Procedure

For In Vitro Diagnostic Use. Rx only.

Reporting and interpretation of FISH results should be consistent with professional standards of practice and should take into consideration other clinical and diagnostic information. This kit is intended as an adjunct to other diagnostic laboratory tests and therapeutic action should not be initiated on the basis of the FISH result alone. Failure to adhere to the protocol may affect the performance and lead to false results.

Each lab is responsible for establishing their own cut-off values. Each laboratory should test sufficiently large number of samples to establish normal population distribution of the signal levels and to assign a cut-off value. The product is for professional use only and is intended to be interpreted by a qualified Pathologist or Cytogeneticist.

The device has not been specifically validated in patients with <20% blast count.

For sale in the US only. This product has not been licensed in accordance with Canadian law.


1.Swerdlow et al., (eds,) WHO Classification of Tumours of Haematopoietic and Lymphoid Tissue, Lyon, France, 4th edition, IARC,2017.

2. Reikvam HH et al., J Biomed Biotechnol. 2011;2011:1–23.

3. Grimwade D et al., Blood. 2001 Sep 1;98(5):1312–20.

4. Harrison CJ et al., J Clin Oncol. 2010;28(16):2674–81.

5. Grimwade D et al., Blood. 2010;116(3):354–65.

Microscope Images

AML ETO microscope v2
Dish1Sample and Slide Preparation
Droplet5Post-Hybridization Washes
Microscope green6Analyze

For additional support and advice about the FISH technique please visit our support page