Alternative Name
HER2, HER-2/neu, PATHWAY HER2 (4B5), anti-Her2
Methodology
Immunohistochemistry (IHC)
Test Description

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 normal and neoplastic tissue. The test is FDA-approved with the indication as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered. Staining is performed according to the package insert. Scoring for breast cases is performed according to ASCO/CAP 2013 guidelines. Scoring for gastroesophageal and other tissues is according to the 2010 ToGA trial standards.
HER2 is an oncogene that is over-expressed in a variety of cancers including some breast carcinomas. The expected breast cancer overexpression rate varies based on the grade and type of cancer. Known artifacts, such as edge artifact, tissue retraction and tissue crush may give the false impression of overexpression. Care should be taken to avoid assessing these areas, especially in needle core biopsies that generally harbor all of these artifacts.

Specimen Requirements
  • A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type

    or

  • One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 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.

Storage and Transportation

Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

CPT Code(s)*
88360x1; 88361x1
Turnaround Time

Global: 48 hours, Image Analysis (tech-only): 36 hours, Tech-Only (stain only): 24 hours

Level of Service
Global
Stain Only

*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.