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HER2 (Other)
- Immunohistochemistry (IHC)
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. 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 tissues. Staining is performed according to the package insert. Scoring is performed using the following:
HER2 (Other) with Breast scoring uses the 2023 CAP/ASCO guidelines for breast cancer for HER2 evaluation. Breast scoring is recommended indications such as endometrium cancer, salivary duct carcinoma, serous carcinoma, ovarian cancer, and other clinical indications without consensus guidelines.
HER2 (Other) with Gastric scoring uses the 2016 CAP/ASCP/ASCO consensus guidelines for gastric/gastroesophageal adenocarcinoma for HER2 evaluation.
Turnaround time
Global: 2 Day, Tech-Only (stain only): 1 Day
Level of Service
- Global
- Technical Only
New York Approved: Yes
Specimen Requirements
A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered. Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition. For PD-L1 22C3 evaluation, tissue submitted must have 100 viable tumor cells present.
Storage and Transportation
Storage & Transportation: Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.
CPT Code(s)*
88360x1
*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.
Last Updated: January 22, 2025