ERBB2 (HER2/neu) (HercepTest) with Interpretation by Immunohistochemistry, Tissue
Also known as: HERCEPIP
Use
The test aids in predicting the response to HER2-directed therapy in patients with breast carcinoma or gastroesophageal adenocarcinoma. It serves as an alternate test to confirm equivocal dual in situ hybridization (ISH) or fluorescence in situ hybridization (FISH) results. The interpretation utilizes specific guidelines and ensures proper processing and evaluation of the tissue sample to provide accurate results.
Special Instructions
Pathology report including tissue source and tumor origin must be submitted. Document time from tissue acquisition to fixation and fixation duration on the requisition or at the time of order. If multiple specimens are submitted, clarify the selection process or provide individual orders for each sample.
Limitations
The predictive value of HER2 expression, if detected, is uncertain in tumors other than breast and gastric. The test relies on formalin-fixed, paraffin-embedded tissue stained using the proprietary HercepTest methodology. Deviations in tissue processing, such as insufficient fixation time or use of non-standard fixatives, may negatively impact test results. Tissue compliance with ASCO/CAP guidelines is crucial for accurate interpretation.
FDA ApprovedNew York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 18474-7
- 94736-6
- 31208-2
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
3 slides
Collection Instructions
Formalin fix (10 percent neutral buffered formalin) and paraffin embed within 30 minutes of removal. Transport tissue block or 5 unstained slides in a tissue transport kit.
Storage Instructions
Room temperature or refrigerated. Ship in cooled container during summer months.
Causes for Rejection
Paraffin block with no tumor tissue; fixation delayed more than one hour; non-standard fixative used; tissue fixed for less than 6 hours or more than 72 hours; decalcified specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |