HER2 FISH test

Diagnostic Use

The HER2 (ERBB2) protein is expressed at a low level in normal cells, but over-expressed in 18-20% of breast cancers.

Patients with HER2 gene amplification are eligible for treatment with trastuzumab (Herceptin®), which targets HER2 and has proved remarkably effective in patients with a tumour over-expressing the protein, in both metastatic and adjuvant settings.

Department

Genetics - Cytogenetics

Delphic Registration Code

CTGN

Synonyms

ERBB2 FISH

Turnaround Time

10 days

Test Code

9033

Specimen Type

• Tissue

Specimen Requirements

Tube/Container Type:

Preferred

• Slide(s)

Pre-testing Requirements

Only tissue preserved in neutral buffered formalin and paraffin embedded is suitable for use. NB: Samples de-calcified in Formic acid are not suitable for FISH as this process affects the integrity of the DNA.

Tissue specimens should be cut into sections of 2-4µm, ideally on poly-L-lysine slides.
The H&E slide must be assessed by a pathologist prior to receipt, and appropriate areas for FISH analysis should be clearly marked.

Additional Specimen Information

Ensure one H&E slide and 2-3 unprocessed slides are supplied.
Slide must be clearly labelled with two patient identifiers, matching those on the request form.

Aliquot Instructions

Transport to Lab

Ambient (8 - 24 degrees Celsius)

Additional Referral/Aliquot Information

Transport to lab in slide-holders or boxes at ambient temperature

Interpretation

Current cases are analysed and reported in accordance with CAP/ASCO recommendations (2013):

Wolff et al: Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update. J Clin Oncol. 2013 Nov 31(31): 3997-4014.

For cases received prior to 1st November 2013, the CAP/ASCO Guidelines (2007) were followed:

Wolff A C, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan 1;25(1): 118-45.

Please contact this laboratory if you have any questions regarding these changes.

Test Method

Fluorescence in situ hybridisation (FISH) on formalin fixed paraffin embedded tissue (FFPE) slides using a probe specific to the HER2 (ERBB2) locus and a chromosome 17 control probe.

Non-Funded Test Cost

$444.13 (Exclusive of GST)

Billing Code

9033

Contact Information

Enquiry Form