HERCEPT TEST
Immunohistochemistry (IHC) · Gastroenterology, Women's Health
HercepTest™ is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest™ specifically demonstrates overexpression of HER2 protein. Positive or negative results aid in the classification of abnormal cells/tissues and provide a basis for Herceptin® treatment selection. Decision regarding Herceptin® treatment should be made within the context of the patient's clinical history. HercepTest™ is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered and for breast cancer patients for whom PERJETA™ (pertuzumab) or KADCYLA™ (ado-trastuzumab emtansine) treatment is being considered (see Herceptin®, PERJETA™, and KADCYLA™ package inserts).
Table of Contents
Assay Description
HercepTest™ is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest™ specifically demonstrates overexpression of HER2 protein. Positive or negative results aid in the classification of abnormal cells/tissues and provide a basis for Herceptin® treatment selection. Decision regarding Herceptin® treatment should be made within the context of the patient's clinical history. HercepTest™ is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered and for breast cancer patients for whom PERJETA™ (pertuzumab) or KADCYLA™ (ado-trastuzumab emtansine) treatment is being considered (see Herceptin®, PERJETA™, and KADCYLA™ package inserts).
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.
Storage and Transport
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.
Specimen Rejection Criteria
All specimens must be submitted according to the test directory instructions. Before submitting specimen, please carefully review specimen requirements.
Listed below are possible causes for delays in specimen processing or possible specimen rejections or cancellations:
- No patient identification on requisition form
- No patient identification on specimen container or slides
- No referring provider
- No account information provided
- No test ordered on requisition
- No specimen source provided
- Inappropriate specimen type
- Insufficient volume for analysis
- Inappropriate specimen container
- Improper specimen transport
- Specimen leaked in transport
- Specimen submitted in incorrect or expired transport media
- Slides broken beyond repair on receipt
- Conflict between patient name on specimen and requisition form
- Specimen not properly preserved
- Sample containing a needle
A representative from Client Services will attempt to contact your office to resolve specimen problems. Additional documentation may be requested from your office to be returned by fax. In the event that resolution is not possible, the specimen may be returned to your office.
Turn Around Time (TAT)
2-3 Days.
CPT Codes*
88341, 88342, 88360