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Biopsy Breast (Modified Radical Mastectomy) +ER+PR+HER2NEU+KI67) Test

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Biopsy Breast (Modified Radical Mastectomy) +ER+PR+HER2NEU+KI67) Test

Short Name: Breast Biopsy with IHC Panel

Also known as: Breast Biopsy with ER/PR/HER2/Ki67, Modified Radical Mastectomy Pathology, Breast Cancer Biomarker Panel

Biopsy Breast (Modified Radical Mastectomy) +ER+PR+HER2NEU+KI67) Test test available at DNA Labs India for ₹12,750. Uses Histopathology, Immunohistochemistry (IHC) on Tissue (Breast tumor specimen from Modified Radical Mastectomy) samples. Results in Reports are available within 6 days after the specimen is received in the laboratory.. Free home collection in 300+ cities across India.

Histopathology with ImmunohistochemistryFemaleAdult🏠 Home Collection

🩺 Medically Reviewed By

Overview

The purpose of this test is to provide a definitive histopathological diagnosis of breast cancer and to determine the expression of key biomarkers (ER, PR, HER2/neu, Ki67) that are essential for treatment planning. The results help oncologists decide on the use of endocrine therapy (tamoxifen, aromatase inhibitors), anti-HER2 therapy (trastuzumab), and assess tumor proliferation rate, which correlates with prognosis.

Test Code
6061
CPT Code
88305, 88360, 88341
ICD Code
C50.9
Price
₹12,750
Sample Type
Tissue (Breast tumor specimen from Modified Radical Mastectomy)
Result Time
Reports are available within 6 days after the specimen is received in the laboratory.
Fasting Required
No
Method
Histopathology, Immunohistochemistry (IHC)
Step 1

Sample Collection

No special preparation required. The specimen is obtained during surgery (Modified Radical Mastectomy). Ensure the tissue is placed in 10% Neutral Buffered Formalin immediately after excision.

Method: Surgical excision (Modified Radical Mastectomy)

Step 2

Laboratory Analysis

The tissue specimen is collected by the surgeon during the mastectomy procedure. It is then sent to the pathology laboratory in a formalin-filled container.

Step 3

Report Delivery

The specimen is processed in the laboratory. No specific patient care instructions are needed post-collection, as the test is performed on the excised tissue.

Timeline: Reports are available within 6 days after the specimen is received in the laboratory.

Patient Instructions

1
Before the Test:No special preparation is needed. The test is performed on tissue obtained during surgery.
2
During the Test:The tissue specimen is processed and analyzed by a pathologist. No patient involvement is required.
3
After the Test:You will receive the report in 6 days. Discuss the results with your oncologist to plan further treatment.

About This Test

Who Should Get This Test

The purpose of this test is to provide a definitive histopathological diagnosis of breast cancer and to determine the expression of key biomarkers (ER, PR, HER2/neu, Ki67) that are essential for treatment planning. The results help oncologists decide on the use of endocrine therapy (tamoxifen, aromatase inhibitors), anti-HER2 therapy (trastuzumab), and assess tumor proliferation rate, which correlates with prognosis.

How to Prepare

  • Tissue must be placed in 10% Neutral Buffered Formalin immediately after excision
  • Volume of formalin should be at least 10 times the tissue volume
  • Label the container with patient identification and date
  • Transport at room temperature to the laboratory within 24 hours
  • Do not freeze the specimen

Doctor's Notes

Reviewed by — MBBS, MD (Pathology) · Reg. No. 21521

"This comprehensive panel is essential for guiding treatment decisions in breast cancer, including hormonal therapy and targeted therapy eligibility."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeTissue (Breast tumor specimen from Modified Radical Mastectomy)
Sample VolumeTissue specimen in 10% Neutral Buffered Formalin
ContainerSterile container with 10% Neutral Buffered Formalin
Collection MethodSurgical excision (Modified Radical Mastectomy)

Sample Stability

Room temperature: 24 hours
Refrigerated (2-8°C): 72 hours
Frozen: Not recommended
Sample Rejection Criteria:
  • Unlabeled or mislabeled specimen
  • Specimen not in formalin or in inappropriate fixative
  • Inadequate tissue sample
  • Specimen with excessive necrosis or autolysis
  • Specimen received after prolonged delay without proper preservation

Understanding Your Results

The results of this panel provide critical information for breast cancer management. ER/PR positivity indicates that hormonal therapy may be effective. HER2 positivity (3+ or FISH amplified) suggests benefit from anti-HER2 targeted therapy. Ki67 index reflects tumor proliferation and helps in prognostic assessment.
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Luminal A-like subtype; endocrine therapy is effective, chemotherapy may be less beneficial.

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Luminal B-like subtype; endocrine therapy plus chemotherapy may be considered.

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HER2-enriched subtype; anti-HER2 therapy (e.g., trastuzumab) is indicated.

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Triple-negative subtype; chemotherapy is the mainstay, targeted therapies may be limited.

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Reflex FISH testing is required to determine HER2 amplification status.

⚠️ When to Consult a Doctor:

Consult your oncologist immediately after receiving the report to discuss treatment options. If you experience any new symptoms or have concerns about your diagnosis, do not delay in seeking medical advice.

Limitations

  • HER2 IHC 2+ (equivocal) requires reflex FISH testing for definitive result
  • Ki67 scoring may have inter-observer variability
  • Results are dependent on tissue quality and fixation
  • This test is not a screening test; it is performed on tissue from mastectomy

Risks & Considerations

  • No additional risks from the test itself, as it is performed on excised tissue
  • Surgical risks from the mastectomy procedure are separate and should be discussed with the surgeon

Interfering Factors

  • Improper fixation of tissue (delayed or inadequate formalin fixation)
  • Decalcification of tissue (if bone involved)
  • Necrosis or crush artifacts in specimen
  • Prior chemotherapy or radiation therapy may alter biomarker expression
  • Inadequate tissue sample size

Compare With Similar Tests

TestBiopsy Breast (Modified Radical Mastectomy) +ER+PR+HER2NEU+KI67)Breast Biopsy (Core Needle) with IHCHER2 FISH TestOncotype DX (Genomic Assay)CA 15-3 Tumor Marker
ComparisonBiopsy Breast (Modified Radical Mastectomy) +ER+PR+HER2NEU+KI67)

Frequently Asked Questions

What is the cost of the Biopsy Breast (Modified Radical Mastectomy) +ER+PR+HER2NEU+KI67 test?
The test costs INR 12750 at DNA Labs India. This includes histopathology and immunohistochemistry for ER, PR, HER2/neu, and Ki67.
What is the sample type required for this test?
The sample is a tissue specimen from the breast obtained during a Modified Radical Mastectomy. It must be placed in 10% Neutral Buffered Formalin.
Is fasting required before this test?
No, fasting is not required for this test. It is performed on tissue obtained during surgery.
How long does it take to get the report?
The report is available within 6 days after the specimen is received in the laboratory.
What do ER and PR positive results mean?
ER and PR positive results indicate that the tumor cells have receptors for estrogen and progesterone. This means hormonal therapy (like tamoxifen) may be effective in blocking these hormones and slowing tumor growth.
What does HER2/neu positive mean?
HER2/neu positive (3+ by IHC or FISH amplified) means the tumor overexpresses the HER2 protein, making it eligible for targeted therapy such as trastuzumab (Herceptin).
What is Ki67 and why is it important?
Ki67 is a protein that indicates cell proliferation. A high Ki67 index (>30%) suggests a more aggressive tumor, which may require more intensive chemotherapy.
Can this test be done at home?
Yes, DNA Labs India offers free home sample collection for this test. However, since the sample is a surgical specimen, it is typically collected at the hospital during surgery and then sent to our lab.
Is a doctor's prescription required?
Yes, a doctor's prescription is required for this test. It is not applicable for surgery and pregnancy cases or people planning to travel abroad.
What is the turnaround time for this test?
The turnaround time is 6 days from the time the specimen is received in the laboratory.
Are there any risks associated with this test?
No, there are no additional risks from the test itself, as it is performed on tissue already removed during surgery. The surgical risks are separate and should be discussed with your surgeon.
Is this test covered by insurance?
Coverage depends on your insurance policy. We recommend checking with your insurance provider. DNA Labs India also offers affordable pricing and discounts for online bookings.
Worried about the process? Our certified phlebotomists collect thousands of samples every month across India. The process takes under 5 minutes and is virtually painless. Questions? Message us on WhatsApp — we're here 7 days a week.

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