Code
APH-HERX-01AX
Test
Active-Compendium
88360x1; 88361x1
Clinical
Pathology
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.
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Flag Active
True
Orderable 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 2023 guidelines.
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.
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.
Orderable Turn Around Time
Global: 2 Day, Image Analysis (Tech-Only): 2 Day, Tech-Only (stain only): 1 Day
Keywords
Extra Note
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.
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["HER2"]}}
Keywords string
HER2 expression, HER2 IHC, human epidermal growth factor 2, human epidermal growth factor 2 expression HER2 Breast
Title URL
her2-breast