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Product summary

  • Technology FISH
  • Application Haematology
  • Areas of interest AML
  • Region 16q22
  • Label    
  • Product Code CE-LPH 022 (10 tests)
    CE-LPH 022-S (5 tests)
  • Regulatory Status In vitro diagnostic.



Probe specification

  • CBFB, 16q22, Red
  • MYH11, 16p13.1, Green

The CBFB probe, labelled in red, covers a 617kb region, within 16q22 and includes the CBFB gene. The MYH11 probe, labelled in green, covers a 621kb region within 16p13.1 and includes the MYH11 gene.


Probe information

The CBFB (corebinding factor beta subunit) gene is located at 16q22, whilst the MYH11 (myosin heavy chain 11) gene is located at 16p13.1. The inversion inv(16)(p13.1q22) and the translocation t(16;16)(p13.1;q22) give rise to the CBFB::MYH11 fusion gene. Acute myeloid leukaemia with CBFB::MYH11 fusion is a recognised disease entity according to the World Health Organization (WHO) classification1. This AML type comprises in 5-8% of cases in younger adult patients and decreases in incidence in older adults1. The inv(16)(p13.1q22) is the most common cytogenetic alteration detected in ~95% of CBFB::MYH11 patients1. The prognosis of AML with CBFB::MYH11 is favourable, with long-term survival rates of ~50% in adults1,2.

Intended purpose

The CytoCell® CBFβ (CBFB)/MYH11 Translocation, Dual Fusion probe is a qualitative, non-automated, fluorescence in situ hybridisation (FISH) test used to detect chromosomal rearrangements between the 16p13.1 region on chromosome 16 and the 16q22 region on chromosome 16 in Carnoy’s solution (3:1 methanol/acetic acid) fixed haematologically-derived cell suspensions from patients with confirmed or suspected acute myeloid leukaemia (AML).


Indications for use

This device is designed as an adjunct to other clinical and histopathological tests in recognised diagnostic and clinical care pathways, where knowledge of CBFB::MYH11 translocation status would be important for clinical management.



This device is designed to detect rearrangements with breakpoints in the region covered by the red and green clones in this probe set, which includes the CBFB and MYH11 regions. Breakpoints outside this region, or variant rearrangements wholly contained within this region, may not be detected with this device.

This device is not intended for: use as a stand-alone diagnostic, use as a companion diagnostic, prenatal testing, population-based screening, near-patient testing, or self-testing.

This device has not been validated for sample types, disease types, or purposes outside of those stated in the intended purpose.

It 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.

Reporting and interpretation of FISH results should be performed by suitably qualified staff, consistent with professional standards of practice, and should take into consideration other relevant test results, clinical and diagnostic information.

This device is intended for laboratory professional use only.

Failure to adhere to the protocol may affect the performance and lead to false positive/negative results.

What our customers say


  1. WHO Classification of Tumours Editorial Board. Haematolymphoid tumours [Internet; beta version ahead of print]. Lyon (France): International Agency for Research on Cancer; 2022 [cited 2023 Nov 03]. (WHO classification of tumours series, 5th ed.; vol. 11). Available from:
  2. Döhner, et al. Blood. 2022;140(122):1345-1377.

Recommended protocol for CytoCell haematology FISH

Select a protocol step to view:

Sample and slide preparation

1. Sample & Slide Prep Dark Blue
  • Spot the cell sample onto a glass microscope slide. Allow to dry.
  • Immerse the slide in 2x Saline Sodium Citrate (SSC) for 2 minutes at room temperature (RT) without agitation.
  • Dehydrate in an ethanol series (70%, 85% and 100%), each for 2 minutes at RT.
  • Allow to dry.
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Haematology FISH protocol

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