Days Set Up
Monday - Thursday
Analytic Time

3-10 days

MiChart Code
HER2 by FISH
Soft Order Code
MHER2

Test Updated:

Synonyms

FHER2
MHER2
MLABEL
HER2FISH
FISH HER2-NEU
HER-2/neu Amp, Breast CA, FISH
HER2 Amp Breast Cancer, FISH
17q11.2-q12 Probe
FISH for HER-2 Amplification Detection
c-erbB2 Amplification Detection
Herceptin (Trastuzumab) therapy
HER-2/neu by FISH
HER2 Amplification by FISH

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Test Overview

Test Methodology

Fluorescence In Situ Hybridization (FISH)

Test Usage

This test detects amplification of the HER2 gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded breast cancer tissue specimens. FISH is performed using PathVysion (Abbott Molecular, Inc) probes to the HER2 locus (17q11.2-q12) and the chromosome 17 centromere (D17Z1). Results are reported as a HER2:D17Z1 copy number ratio and interpreted according to ASCO/CAP guideline recommendations. HER2 amplification status can be a useful adjunct indicator of prognosis, and can assist in the selection of patients for whom Herceptin (Trastuzumab) treatment is being considered. This test can also rule-out or confirm gene amplification in cases previously evaluated by HER2 immunohistochemistry (IHC), especially those with equivocal (2+) IHC results.

Reference Range

Interpretive report provided.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Specimen Requirements

Collection Onsite

A formalin-fixed, paraffin-embedded tissue block containing sufficient neoplastic cells is preferred. Unstained slides (3, 4-micron slides) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature. The HER2 IHC (immunohistochemistry) slide must also be included with this request. A copy of the HER2 IHC pathology report should accompany this request. Specimens submitted must be fixed between 6 and 72 hours in 10% buffered Formalin.

Collection Offsite

A formalin-fixed, paraffin-embedded tissue block containing sufficient neoplastic cells is preferred. Unstained slides (3, 4-micron slides) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature. The HER2 IHC (immunohistochemistry) slide must also be included with this request. A copy of the HER2 IHC pathology report should accompany this request. Specimens submitted must be fixed between 6 and 72 hours in 10% buffered Formalin.

Normal Volume
Formalin-fixed, paraffin-embedded tissue
Minimum Volume
 

Billing Information

CPT Code
88377-TC
Pro Fee Code
 
LOINC
31150-6

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Our High Standard

Quality that sets us apart

As the reference laboratory division of Michigan Medicine's Department of Pathology, MLabs shares the institution's commitment to applying established quality principles to clinical laboratory testing. Like other large organizations in complex, consequential fields, we rely on an established approach to monitor quality throughout the testing process.