HER2 Gastric/GEA

HER2, a member of the epidermal growth factor receptor family, is a transmembrane protein with tyrosine kinase activity. Gene amplification and protein overexpression of HER2 have been found in a variety of tumors, including gastric/gastroesophageal adenocarcinoma. This test uses the Ventana PATHWAY anti-HER-2/neu antibody (clone 4B5) for the semi-quantitative detection of HER-2 antigen in sections of FFPE gastric/gastroesophageal adenocarcinoma. Staining is performed according to the package insert. Scoring for HER2 is performed according to 2016 CAP/ASCP/ACSO consensus guidelines for gastric/gastroesophageal adenocarcinoma.

Specimen Requirements

Preferred specimen (FFPE block):
A formalin-fixed, paraffin-embedded (FFPE) tissue block is the preferred specimen type. Use 10% NBF fixative; do not use zinc or mercury fixatives.
If submitting slides (instead of a block):
Submit the following. All slides cut at 4–5 microns. Please use positively-charged slides and 10% NBF fixative.
H&E slide: One (1) unbaked, unstained slide for H&E staining (required)
Cut Slides: Two (2) positively charged unstained slides for each IHC test/antibody ordered
Specimen identification:
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.

Storage and Transportation

Slides may be stored at room temperature; transport with cold pack, making sure cold pack is not in direct contact with specimen.
NYS Clients: Please provide Date and Time of Collection.

CPT Code(s)*

88360x1
Turnaround time
1-2 Days

Global: 2 Days
Tech-Only (stain only): 24 Hours

Level of Service

  • Global
  • Tech Only

Integrations

  • Epic Aura

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New York Approved: Yes

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

Biomarkers

Immunohistochemistry (IHC)
Expression
HER2

Last Updated: March 18, 2026

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