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Product summary

  • Technology FISH
  • Application Solid tumour
  • Areas of interest Breast cancer, Lung cancer
  • Region 7p11.2
  • Label    
  • Product Code LPS 003 (10 tests)
    LPS 003-S (5 tests)
  • Regulatory Status In vitro diagnostic. This product is intended to be used on 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

  • EGFR, 7p11.2, Red
  • D7Z1, 7p11.1-q11.1, Green

The EGFR Amplification probe consists of a red 295kb probe spanning the gene region 7p11.2. The centromeric probe in green acts as a control for chromosome 7.


Probe information

The EGFR (previously known as HER1), Epidermal Growth Factor Receptor, gene on chromosome band 7p11.2, is a type 1 tyrosine kinase receptor for members of the epidermal growth factor family. Binding of the EGFR and epidermal growth factor proteins leads to cell proliferation1.

Abnormally elevated EGFR kinase activity can lead to proliferative diseases such as non-small-cell lung carcinoma (NSCLC), which accounts for 80-85% of all lung cancers2, and less frequently breast cancer3, amongst others.

There are three small molecule EGFR kinase inhibitor drugs in clinical use (gefitinib, erlotinib and lapatinib) and several others that are currently undergoing clinical development4. Approximately 10% of lung cancer patients show a rapid and dramatic response to these Tyrosine Kinase Inhibitors (TKIs)5,6.

FISH has proven to be useful for determining the amplification status of EGFR in NSCLC and has therefore aided in the selection of patients for treatment with EGFR TKIs7.


  1. Voldborg et al., Annals of Oncology 8: 1197-1206,1997
  2. Jemal A et al., CA Cancer J Clin 2006;56:106-30
  3. Bhargava R et al., Modern Path 2005;18:1027-33
  4. Hegymegi-Barakonyi B, Curr Opin Mol Ther 2009;11(3):308-21
  5. Lynch TJ et al., N E J Med 2004;350:2129-39
  6. Pao W et al., Proc Natl Acad Sci USA 2004;101(36):13306-11
  7. Hirsch FR et al., JCO 2008;26(20): 3351-7

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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