HER2 Breast
Also known as: HER2, HER-2/neu, PATHWAY HER2 (4B5), anti-Her2
Use
This test is FDA-approved as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered. HER2 is an oncogene that is over-expressed in a variety of cancers, including some breast carcinomas.
Special Instructions
Staining is performed according to the package insert. Scoring for breast cases is performed according to ASCO/CAP 2023 guidelines. Known artifacts, such as edge artifact, tissue retraction, and tissue crush may give a false impression of overexpression. Care should be taken with needle core biopsies.
Limitations
Artifacts such as edge artifact, tissue retraction, and tissue crush may lead to false overexpression impressions. These should be avoided, especially in needle core biopsies.
FDA ApprovedNew York Approved
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred, or one unbaked, unstained slide for H&E staining (required), and 2-3 positively charged unstained slides for each test ordered. Block and slide identifiers should match the specimen ID.
Storage Instructions
Use cold pack for transport, ensuring the cold pack is not in direct contact with specimen.