CytoCell CBFß (CBFB)/MYH11 Translocation, Dual Fusion

Probe specification

• CBFβ, 16q22, Texas Red
• MYH11, 16p13.1, FITC Green

The CBFβ (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit consists of a 617kb probe, labeled in Texas Red, covering a region, within 16q22 including the CBFB gene; and a 621kb probe, labeled in FITC green, covering a region within 16p13.1 including the MYH11 gene.

Probe information

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 rearrangement^1,2.

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.

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