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FISH - Equivocal HER2 (ERBB2) Test

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FISH - Equivocal HER2 (ERBB2) Test

Short Name: FISH HER2 Test

Also known as: HER2 FISH Test, Equivocal HER2 Gene Amplification Test

FISH - Equivocal HER2 (ERBB2) Test test available at DNA Labs India for ₹12,870. Uses FISH on Formalin fixed paraffin embedded tissue block samples. Results in Approximately 1 week from sample receipt to report generation.. Free home collection in 300+ cities across India.

FISH AssayAdult🏠 Home Collection

🩺 Medically Reviewed By

Overview

The primary purpose of this FISH test is to clarify the HER2 status in breast cancer patients with equivocal initial results. Accurate HER2 determination is essential for identifying patients who may benefit from HER2-targeted therapies, thereby personalizing treatment and improving outcomes.

Test Code
22
Price
₹12,870
Sample Type
Formalin fixed paraffin embedded tissue block
Result Time
Approximately 1 week from sample receipt to report generation.
Fasting Required
No
Method
FISH
Step 1

Sample Collection

Ensure all required forms, including Chromosome & FISH analysis Requisition Form (Form 17), are duly filled and submitted.

Method: Biopsy or Surgery

Step 2

Laboratory Analysis

Tissue sample is collected via biopsy or surgical procedure.

Step 3

Report Delivery

Sample is processed and analyzed using fluorescence in situ hybridization method.

Timeline: Approximately 1 week from sample receipt to report generation.

Patient Instructions

1
Before the Test:Ensure proper sample collection and mandatory form submission.
2
During the Test:Tissue sample is processed, hybridized with fluorescent probes for HER2 detection, and analyzed under a microscope.
3
After the Test:Results are interpreted by pathologists and reported within one week.

About This Test

Who Should Get This Test

The primary purpose of this FISH test is to clarify the HER2 status in breast cancer patients with equivocal initial results. Accurate HER2 determination is essential for identifying patients who may benefit from HER2-targeted therapies, thereby personalizing treatment and improving outcomes.

How to Prepare

  • Submit formalin fixed paraffin embedded tissue block
  • Ship at room temperature
  • Tissue block must contain at least 10% tumor tissue
  • Submit duly filled Chromosome & FISH analysis Requisition Form (Form 17)

Doctor's Notes

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

"This FISH test is crucial for resolving equivocal HER2 status, which directly impacts treatment decisions in breast cancer."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeFormalin fixed paraffin embedded tissue block
Collection MethodBiopsy or Surgery

Sample Stability

Stable at room temperature for 24-48 hours
Avoid freezing or extreme temperatures
Sample Rejection Criteria:
  • Insufficient tumor tissue in sample (<10%)
  • Improperly filled or missing requisition form
  • Degraded or inadequate tissue sample

Understanding Your Results

Results indicate the HER2 gene amplification status, which is critical for treatment decisions in breast cancer.
📊

HER2 Amplified

Positive for HER2 gene amplification, suggesting eligibility for HER2-targeted therapies.

Action: Consult oncologist for personalized treatment options.

📊

HER2 Non-Amplified

Negative for HER2 gene amplification.

Action: Discuss alternative treatment approaches with physician.

📊

Equivocal

Borderline results; further testing may be required for definitive conclusion.

Action: Repeat test or use alternative probe as per ASCO/CAP guidelines.

⚠️ When to Consult a Doctor:

If symptoms of breast cancer persist, if test results are equivocal, or to discuss treatment plans based on HER2 status.

Limitations

  • Only applicable for equivocal cases from initial HER2 testing
  • Requires formalin-fixed paraffin-embedded tissue sample
  • Cannot be performed on blood or other non-tissue samples
  • Results may be affected by tumor heterogeneity

Risks & Considerations

  • Minimal risk associated with tissue sample collection (e.g., biopsy)
  • Possible minor bleeding or infection at collection site
  • Discomfort during the biopsy or surgical procedure

Interfering Factors

  • Poor tissue fixation or processing
  • Insufficient tumor cell content (<10%)
  • Tissue degradation or contamination
  • Use of non-standardized probes or reagents

Compare With Similar Tests

TestFISH - Equivocal HER2 (ERBB2) TestIHC HER2 TestSISH TestCISH Test
ComparisonFISH - Equivocal HER2 (ERBB2) Test

Frequently Asked Questions

What is the FISH - Equivocal HER2 (ERBB2) Test?
It is a fluorescence in situ hybridization test used to detect HER2 gene amplification in breast cancer patients with equivocal initial test results.
Why is this test recommended?
To accurately determine HER2 status for treatment planning, especially when initial tests are inconclusive, as per ASCO/CAP guidelines.
What does equivocal HER2 status mean?
Equivocal means the initial test result is borderline, requiring further evaluation with FISH for clarification.
How is the FISH test performed?
The test uses fluorescent probes to bind to the HER2 gene on a tissue sample, allowing visualization under a fluorescence microscope.
What sample is needed for this test?
A formalin-fixed paraffin-embedded tissue block from biopsy or surgery, with at least 10% tumor tissue.
Is any preparation required before the test?
You need to submit the duly filled Chromosome & FISH analysis Requisition Form (Form 17). No fasting is required.
How long does it take to get the results?
Results are typically available within one week after sample receipt.
What is the cost of the test?
The test costs INR 12870, which includes sample collection, analysis, and report generation.
Is home sample collection available?
Yes, DNA Labs India offers free home collection in major cities across India.
Are there any risks associated with the test?
The test itself has no risks, but sample collection via biopsy may involve minimal risks like infection or bleeding.
How accurate is the FISH test for HER2?
FISH is highly sensitive and specific for detecting HER2 gene amplification, considered a gold standard for equivocal cases.
What should I do after receiving the test results?
Consult your oncologist to discuss the results and appropriate treatment options based on HER2 status.
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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Your medical data is protected under Indian law.

Stored in India: All patient records are stored on servers located in India. No data is transferred outside the country.

DPDP Act Compliant: Under the Digital Personal Data Protection Act 2023, you can request deletion of your records at any time by contacting support.

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