First slide
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Product summary

  • Technology FISH
  • Application Solid tumour
  • Areas of interest Lymphoma, Breast cancer, Gastric cancer
  • Region 11q13.3
  • Label    
  • Product Code LPS 030 (10 tests)
    LPS 030-S (5 tests)
  • Regulatory Status In vitro diagnostic. This product is intended to be used on Carnoy’s solution (3:1 methanol/acetic acid) fixed haematological samples, or formalin-fixed paraffin-embedded (FFPE) tissues. Disease information supported by the literature and is not a reflection of the intended purpose of this product.



Probe specification

  • CCND1, 11q13.3, Red
  • CCND1, 11q13.3, Green

The CCND1 product consists of two green 154kb, 289kb probes that are positioned centromeric to the CCND1 gene and two red 159kb, 373kb probes, covering the CCND1 gene and surrounding telomeric regions up to the D11S1919 marker.


Probe information

The Cyclin D1 (CCND1) gene located at 11q13.3 encodes a protein that belongs to the highly conserved cyclin family. Mutations, amplifications and overexpression of this gene, which alters cell cycle progression, are observed frequently in a variety of tumours and may contribute to tumourigenesis1.

Cyclins function as regulators of cyclin dependent kinases (CDKs). CCND1 forms a complex with, and functions as a regulatory subunit of, CDK4 or CDK8, whose activity is required for the G1/S transition through the cell cycle1. The translocation t(11;14)(q13;q32) between CCND1 and Immunoglobulin Heavy chain (IGH) has been described as the molecular hallmark for Mantle Cell Lymphoma (MCL)2,5, a subtype of B-cell non-Hodgkin Lymphoma, and results in overexpression of cyclin D1. This translocation is estimated to occur in 53-93% of MCL cases3 and has also been implicated in 10-25% of Multiple Myeloma patients with abnormal cytogenetics4.


  1. RefSeq, Jul 2008
  2. Vose JM, et al., Am J Hematol 2012;87(6):604-9
  3. Rahman K et al., Indian J Pathol 2012;55:66-71
  4. Hoyer JD et al., Am J Clin Pathol 2000;113(6):831-7
  5. Avet-Loiseau et al., Genes Chromosomes Cancer. 1998; 23(2):175-82

FFPE tissue preparation and FISH protocol

Select a protocol step to view:

Heat pretreatment

1. Heat Pretreatment Dark Blue
  • Heat 50ml Tissue Pretreatment Solution (Reagent 1) in a porcelain wash jar or coplin jar immersed in a waterbath until it is either boiling or 98 - 100°C.
  • Boil slides for 30 minutes (Note: different incubation times may be required depending on tissue fixation. A 30-minute incubation is a recommended starting point).
  • Wash in PBS or dH2O at room temperature (RT) for 2 x 3 minutes.
Solid tumour FFPE FISH protocol Video Image
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Solid tumour FFPE FISH protocol

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