Immunohistochemistry HER-2 / ERBB2 (Breast) Test
Short Name: IHC HER-2/ERBB2
Also known as: HER-2 IHC Test, ERBB2 Immunohistochemistry, HER2/neu Protein Expression Test, HER-2 Breast Tissue Marker
Immunohistochemistry HER-2 / ERBB2 (Breast) Test test available at DNA Labs India for ₹1,837. Uses Immunohistochemistry (IHC) on Tumor tissue samples. Results in Sample processed daily by 6 pm; Report: Tissue biopsy 5 working days, Tissue large complex 7 working days. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr Pasupathy Arumugam
Consultant Pathologist · Reg: 21521
Last reviewed: September 7, 2026
Overview
The primary purpose of the Immunohistochemistry HER-2/ERBB2 Breast Test is to determine the HER-2 protein expression status in breast cancer tissue. HER-2 overexpression is an indication for Herceptin (trastuzumab) therapy and other HER-2 targeted treatments. This test helps oncologists formulate an appropriate and personalized treatment plan for breast cancer patients. It is an essential part of the standard breast cancer pathology evaluation alongside ER, PR, and Ki-67 testing.
- Test Code
- 943
- Price
- ₹1,837
- Sample Type
- Tumor tissue
- Result Time
- Sample processed daily by 6 pm; Report: Tissue biopsy 5 working days, Tissue large complex 7 working days
- Fasting Required
- No
- Method
- Immunohistochemistry (IHC)
Sample Collection
No patient preparation is required. A tissue sample is obtained through a prior biopsy or surgical procedure. Ensure the Histopathology report, site of biopsy, and clinical history are provided along with the specimen.
Method: Tissue biopsy / Surgical excision
Laboratory Analysis
Tissue is collected via core needle biopsy, excisional biopsy, or surgical resection by the treating surgeon or pathologist. The specimen is then placed in 10% formal-saline or processed into a formalin-fixed paraffin-embedded (FFPE) block.
Report Delivery
The tissue sample is transported to the laboratory at room temperature. The specimen is processed, sectioned, and stained with HER-2 specific antibodies using standard immunohistochemistry protocols. Results are reviewed and interpreted by a qualified pathologist.
Timeline: Sample processed daily by 6 pm; Report: Tissue biopsy 5 working days, Tissue large complex 7 working days
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of the Immunohistochemistry HER-2/ERBB2 Breast Test is to determine the HER-2 protein expression status in breast cancer tissue. HER-2 overexpression is an indication for Herceptin (trastuzumab) therapy and other HER-2 targeted treatments. This test helps oncologists formulate an appropriate and personalized treatment plan for breast cancer patients. It is an essential part of the standard breast cancer pathology evaluation alongside ER, PR, and Ki-67 testing.
How to Prepare
- Submit tumor tissue in 10% Formal-saline OR as a Formalin Fixed Paraffin Embedded (FFPE) block
- Ship the specimen at room temperature
- Provide a copy of the Histopathology report with the sample
- Include details of the site of biopsy
- Provide relevant clinical history including prior treatment details
Doctor's Notes
Reviewed by Dr Pasupathy Arumugam — MBBS, MD (Pathology) · Reg. No. 21521
"HER-2 status determination is a critical step in the management of breast cancer. Patients with HER-2 overexpression benefit significantly from targeted therapies such as trastuzumab (Herceptin), pertuzumab, and T-DM1. The IHC test serves as the first-line evaluation, and equivocal results (2+) are typically confirmed with FISH testing to ensure accurate treatment planning."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Specimen without adequate tumor tissue or insufficient invasive carcinoma component
- Specimen not fixed in 10% neutral buffered formalin or improper fixative used
- Missing histopathology report or clinical history
- Severely autolyzed or necrotic tissue with no viable tumor cells
- Specimen label mismatch or unlabeled samples
Understanding Your Results
Score 0
Negative. No staining observed or incomplete membrane staining in ≤10% of tumor cells. HER-2 targeted therapy is generally not indicated.
Status: Negative
Score 1+
Negative. Faint/barely perceptible incomplete membrane staining in >10% of tumor cells. HER-2 targeted therapy is generally not indicated.
Status: Negative
Score 2+
Equivocal. Weak to moderate complete membrane staining in >10% of tumor cells. FISH (Fluorescence In Situ Hybridization) testing is recommended to confirm HER-2 gene amplification status.
Status: Equivocal
Score 3+
Positive. Strong, complete, circumferential membrane staining in >10% of tumor cells. Patient is likely eligible for HER-2 targeted therapy such as trastuzumab (Herceptin).
Status: Positive
Consult your oncologist if your HER-2 IHC result is positive (3+), as you may be a candidate for targeted therapy with trastuzumab or other HER-2 directed agents. If the result is equivocal (2+), your doctor will recommend FISH testing for confirmation. Discuss all treatment options, potential side effects, and the role of HER-2 status in your overall treatment plan with your oncologist.
Limitations
- ⚠IHC is a semi-quantitative method; equivocal results (2+) require FISH confirmation
- ⚠The test is performed only on invasive carcinoma components of the tumor
- ⚠Results may vary between laboratories due to differences in antibody clones and staining protocols
- ⚠HER-2 status may change between primary and metastatic sites, warranting re-biopsy in some cases
- ⚠This test does not detect HER-2 gene amplification directly; it evaluates protein expression only
Risks & Considerations
- ●As this test is performed on an already collected tissue specimen, there are no additional risks to the patient from the IHC test itself
- ●The risks associated with the original tissue biopsy procedure include minor bleeding, infection, or bruising at the biopsy site
Interfering Factors
- ●Prolonged or improper fixation of tissue in formalin may affect antigen preservation and staining intensity
- ●Delayed fixation of biopsy specimen can lead to false-negative results
- ●Use of certain fixatives other than 10% neutral buffered formalin may interfere with IHC staining
- ●Tissue processing errors during paraffin embedding may impact antigen retrieval
- ●Intratumoral heterogeneity may cause sampling variability
Compare With Similar Tests
| Test | Immunohistochemistry HER-2 / ERBB2 (Breast) Test | IHC HER-2 | FISH HER-2 | SISH HER-2 |
|---|---|---|---|---|
| Comparison | Immunohistochemistry HER-2 / ERBB2 (Breast) Test |
Frequently Asked Questions
What is the Immunohistochemistry HER-2/ERBB2 Breast Test?
Why is the HER-2 test important for breast cancer patients?
What sample is required for the HER-2 IHC test?
What do the HER-2 IHC scores mean?
What is the difference between IHC and FISH testing for HER-2?
What is the cost of the IHC HER-2/ERBB2 Breast Test in India?
Is home sample collection available for this test?
How long does it take to get the HER-2 IHC test results?
Who should get the HER-2/ERBB2 IHC test?
What happens if my HER-2 IHC result is positive (3+)?
What happens if my HER-2 IHC result is equivocal (2+)?
How should I prepare for the HER-2 IHC test?
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