HER2 Amplification by FISH

Specimen Collection, Storage, and Shipping

Test Information:

Published guidelines from the College of American Pathologists (CAP), American Society for Clinical Pathology (ASCP), and American Society of Clinical Oncology (ASCO) recommend testing for HER2 amplification in invasive breast carcinomas and advanced gastroesophageal adenocarcinomas (GEA). Our laboratory has validated HER2 fluorescence in situ hybridization testing on invasive breast cancer and GEA specimens.

For invasive breast cancer, the Abbott PathVysion® HER2 DNA Probe Kit should be used in a reflexive manner when HER2 immunohistochemical (IHC) shows 2+ staining. Results from the PathVysion Kit are FDA-approved for selecting invasive breast cancer patients for trastuzumab therapy.

For advanced gastroesophageal adenocarcinomas, the Abbott PathVysion® HER2 DNA Probe Kit can be used when HER2 IHC shows 2+ staining.

Requisition Code:

HER2 amplification

CPT Code:


Turn Around Time:

7-10 days

Specimen Requirements:

Decalcified specimens are not accepted.

Formalin-fixed, paraffin embedded tissues

Submit:            Three sections (4 to 6 μm-thick placed on the middle 1/3) on positively-charged slides. Tissues should be placed in 10% neutral buffered formalin within one hour (cold ischemic time of <1 hour) and fixed for 6–72 hours. Tissues must contain invasive tumor (unless requested by the pathologist); sections containing only carcinoma in situ are not acceptable.

Storage:          Room temperature

Remarks:        Submit 1 H&E, IHC slide with area of 2+ marked (mandatory for breast cases), and copy of Surgical Pathology report.

Transport:        See Standard Shipping Procedures

  1. Wolff et al., Arch Pathol Lab Med. 2018 May 30. doi: 10.5858/arpa.2018-0902-SA.
  2. Bartley et al., Arch Pathol Lab Med. 2016 Dec;140(12):1345-1363