• Test Code:
    8180
  • Department:
    Cancer FISH
  • Test Synonyms:
    EGFR FISH
  • CPT Code(s):
    882718827588368 (FFPE)
Background:

The EGFR FISH test is designed to detect amplification of the EGFR (epidermal growth factor receptor) locus at chromosome 7p11.2.  Amplification of EGFR has been reported across an array of cancer and tumor types including lung cancer, and targeted therapeutic intervention is currently available.

FISH studies are useful adjuncts to complete chromosome studies, particularly when following an abnormal clone, assessing relapse and progression, or when material is inadequate for chromosomal analysis.  

  • EGFR/CEP7 probe set, to detect EGFR amplification

Methodology:

FISH is performed on sections of formalin-fixed, paraffin-embedded tumor tissue.   Slides are prepared per standard protocols and 100 interphase cells are scored.  For other specimen types (bone marrow, blood), 100-200 interphase cells are scored.  Cutoff for amplification: ≥2.2 ratio of EGFR:CEP7.

Specimen Requirements:

  • FFPE Slides: Specimen Requirements (*see below for other specimen types):
    • If sending slides, please include H&E stained slide cut from same block
    • Preferred slice thickness is 4-5 microns on positively charged slides.
    • Please submit 3-5 slides.  Store at room temperature.
    • Contact Client Services at (855) 535-1522 for shipping supplies and instructions
  • Bone Marrow:  Shortly before aspiration add 0.2 cc of Sodium Heparin (1,000 units/ml) to tube of transport medium (please contact lab to arrange for transport medium to be sent).  Add at least 1 cc of bone marrow aspirate to the tube and suspend well.  Allow no clots to form.
  • Peripheral blood: May be used if bone marrow is inaspirable and blasts (.5%) are present.  Send in Sodium Heparin tube.
  • Bone core biopsy: May also provide cells in cases where marrow is severely packed.  Send in transport medium with Sodium Heparin.

    *Sterile Ringer’s solution, either lactated or non-lactated and sterile isotonic saline are alternatives, if no complete RPMI is available.  Contact Client Services for more information on media requirements.

It is preferable to collect the specimen before initiation of chemotherapy in the patient.  Tumor samples should be selected from viable areas, with as little normal or necrotic material as possible. 

Unacceptable specimens are acellular, necrotic specimens, septic specimens, specimens in fixative or frozen, or specimens collected more than one week previously.

A REQUISITION FORM MUST ACCOMPANY ALL SAMPLES.  Please include detailed clinical information, including, clinical history.

Test Performed (Days):

Mon - Sat

Turn Around Time:

5-10 days: Contact Lab at 855-KDL-1LAB (535-1522) - Time varies depending on number and type of tests performed.

Shipment Sensitivity Requirements:

  • Keep specimen at room temperature during transit. 
  • Do not use the cold pack provided in the KDL shipping kit. 
  • Ship the specimen overnight express, using the FedEx priority overnight label provided. 
  • The specimen must arrive at the lab no more than 24 hours after collection.

References:

Additional Info: