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CBFß (CBFB)/MYH11 Translocation, Dual Fusion

Fda cleared
Applications
hematology
Area of Interest
AML
Catalogue Numbers
USA-LPH 022 (10 tests)

The CBFB (core-binding factor beta subunit) gene is located at 16q22, while the MYH11 (myosin heavy chain 11) gene is located at 16p13.1. The inversion inv(16)(p13.11q22.1) and the translocation t(16;16) (p13.11;q22.1) give rise to the CBFB-MYH11 fusion gene. Acute myeloid leukemias with inv(16)(p13.11q22.1) or t(16;16)(p13.11;q22.1) form a recognized disease entity according to the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia1. These rearrangements are frequently found in patients with a myelomonocytic subtype with increased bone marrow eosinophils, AML FAB (French-American-British classification) type M4Eo. Cases of therapy-related AML may also have this rearrangement1,2.

Recommended Protocol

https://youtu.be/udHkc0t7VsA

Intended Use

The CBFß (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect rearrangement of the chromosome 16 causing the CBFß-MYH11 (CBFB-MYH11) fusion 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.

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representatives for availability.

References

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

2. Hernandez JM et al., Haematologica. 2000 May;85(5):481–5.

Microscope Images

CBFB microscope v2
Dish1Sample and Slide Preparation
Pipette2Pre-denaturation
Thermometer3Denaturation
Moon4Hybridization
Droplet5Post-Hybridization Washes
Microscope green6Analyze

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