First slide
CytoCell fluorescence in situ hybridisation (FISH) logo.

Product summary

  • Chromosomes
    1411
  • Labels    
  • Disease focus Lymphoma, MM
  • Product code CE-LPH 078-S (5 tests) CE-LPH 078 (10 tests)
  • Regulatory status In vitro diagnostic.
Cytocell Catalogue Probe Packaging With Amber Tube
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Probe design

Overview

Probe specification

  • IGH, 14q32.33, Green

  • MYEOV, 11q13.3, Red

The IGH/MYEOV Plus product contains IGH and MYEOV probe mixes. The IGH mix comprises three green-labelled probes: a 393 kb probe centromeric to the IGH constant region and two probes (324 kb and 289 kb) located within the IGH variable region. The MYEOV mix comprises two red-labelled probes: a 155 kb probe centromeric to MYEOV containing the TPCN2 gene, and a 162 kb probe telomeric to MYEOV containing the CCND1 and ORAOV1 genes.

Probe information

The MYEOV (myeloma overexpressed) and CCND1 (cyclin D1) genes are located at chromosome band 11q13.3 and the IGH (immunoglobulin heavy locus) at 14q32.33. Rearrangements involving the IGH locus and the 11q13 region containing CCND1 and MYEOV occur in multiple myeloma (MM) and certain non-Hodgkin lymphomas (NHL), particularly mantle cell lymphoma (MCL).¹,²

The t(11;14)(q13;q32) translocation is one of the most common rearrangements involving these loci.¹

Rearrangements involving the IGH locus and the 11q13.3 region result in juxtaposition of IGH with CCND1 in MCL and/or MYEOV in MM.³˒⁴

In MM, t(11;14)(q13;q32) is the most common primary IGH translocation and is reported in approximately 15-20% of cases¹ and results in IGH::MYEOV gene fusion. In MCL, IGH::CCND1 is the characteristic genetic abnormality.²

 

Intended purpose

The CytoCell® IGH/MYEOV Plus Translocation, Dual Fusion Probe is a qualitative, non-automated, fluorescence in situ hybridisation (FISH) test used to detect chromosomal rearrangements between the 11q13.3 region on chromosome 11 and the 14q32.33 region on chromosome 14 in Carnoy’s solution (3:1 methanol/acetic acid) fixed haematologically-derived cell suspensions from patients with confirmed or suspected non-Hodgkin lymphoma (NHL) or multiple myeloma (MM).

 

Indications for use

This product is designed as an adjunct to other clinical and histopathological tests in recognised diagnostic and clinical care pathways, where knowledge of IGH::MYEOV/CCND1 translocation status would be important for clinical management.

 

Limitations

This device is designed to detect rearrangements with breakpoints in the regions bounded by the red and green clones in this probe set, which include the IGH, MYEOV and CCND1 genes.

Breakpoints outside these regions or variant rearrangements wholly contained within these regions, such as insertions, may not be detected with this product.

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.

Product documentation

Recommended protocol for CytoCell haematology FISH

Select a protocol step to view:

Sample and slide preparation

Icon representing the sample and slide preparation stage of the fluorescence in situ hybridisation (FISH) protocol.
  • 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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References

  1. Bal S, et al. Multiple myeloma with t(11;14): unique biology and evolving landscape. Am J Cancer Res. 2022;12:2950-2965.
  2. Peterson JF, et al. Characterization of a cryptic IGH/CCND1 rearrangement in mantle cell lymphoma with negative CCND1 FISH studies. Blood Adv. 2019;3:1298-1302.
  3. Greisman HA, et al. IgH partner breakpoint sequences provide evidence that AID initiates t(11;14) chromosomal breaks in mantle cell lymphoma. Blood. 2012;120:2864-2867.
  4. Walker BA, et al. Characterization of IGH locus breakpoints in multiple myeloma. Blood. 2013;121:3413-3419.
  5. Arsham, MS., Barch, MJ. and Lawce HJ. (eds.) (2017) The AGT Cytogenetics Laboratory Manual. New Jersey: John Wiley & Sons Inc.
  6. Mascarello JT, Hirsch B, Kearney HM, et al. Section E9 of the American College of Medical Genetics technical standards and guidelines: fluorescence in situ hybridization. Genet Med. 2011;13(7):667-675.
  7. Wiktor AE, Dyke DLV, Stupca PJ, Ketterling RP, Thorland EC, Shearer BM, Fink SR, Stockero KJ, Majorowicz JR, Dewald GW. Preclinical validation of fluorescence in situ hybridization assays for clinical practice. Genetics in Medicine. 2006;8(1):16–23.
  8. Wolff DJ, Bagg A, Cooley LD et al. Guidance for Fluorescence in Situ Hybridisation Testing in Hematologic Disorders. J Med Diagnost. 2007;9(2):134-143