HER2Neu By DD PCR (Ca Breast) Test: Booking, Price, and Results
About HER2Neu By DD PCR (Ca Breast) Test: Booking, Price, and Results
| Field | Value |
|---|---|
| Also Known As | HER2/ERBB2 ddPCR, HER2 Amplification by droplet digital PCR, ERBB2 copy number by ddPCR |
| Sample Type | FFPE (formalin-fixed, paraffin-embedded) tumour tissue block |
| Fasting Required | No |
| Report Time | 12 Days |
| Recommended For | Women diagnosed with invasive breast cancer; also applicable in rare male breast cancer cases |
| Price | starting at ₹12,000 |
What is a HER2Neu by DD PCR (Ca Breast) Test?
The Her2Neu by DD PCR test detects HER2 gene amplification (too many copies) in breast tumour tissue. It uses droplet digital PCR technology (method) to count the number of HER2 gene copies with high precision. Doctors order this test after a breast cancer diagnosis to guide treatment decisions. The sample used is a preserved tissue block (FFPE block) from a biopsy or surgical specimen.
FFPE block- It is a small piece of tissue (like from a cancer) that is stored in wax so it can be tested later.
What Does a Her2Neu By DD PCR (Ca Breast) Test Measure?
This test analyses whether a breast cancer is HER2-positive or HER2-negative. The table below explains what each one means.
| Parameter | What It Measures |
|---|---|
| HER2/ERBB2 gene copy number | Counts the number of HER2 gene copies in tumour cells to determine if the gene is amplified (overactive) |
| HER2/CEP17 ratio | Compares HER2 gene copies against a reference chromosome marker to confirm amplification status (normal or overamplified) |
Why is a HER2Neu by DD PCR (Ca Breast) Test Done?
This test is ordered when a patient has been diagnosed with invasive breast cancer, and the doctor needs to know the HER2 status before deciding on a treatment plan.
Common Symptoms That May Require This Test
The following symptoms may lead to a breast cancer diagnosis, after which this test is often ordered.
- A lump or thickening in the breast or underarm area
- Unexplained change in the size or shape of the breast
- Nipple discharge that is not related to breastfeeding
- Skin dimpling or puckering on the breast
- Nipple inversion (nipple turning inward)
- Redness, scaling, or flaking of the breast skin
Conditions This Test Can Help Detect
This test helps identify or confirm the following conditions.
- HER2-positive breast cancer, which occurs in roughly 15 to 20% of invasive breast cancer cases
- Eligibility for HER2-targeted therapies such as trastuzumab or pertuzumab
- Equivocal HER2 status that could not be clearly determined by standard tests such as FISH (Fluorescence in situ hybridisation)
How to Prepare and What to Expect
Because this test uses a tissue sample rather than a blood draw, the preparation is different from most routine tests.
Do You Need to Fast?
No fasting is required for this test. The sample is a preserved tissue block from a prior biopsy or surgery, so no dietary restrictions apply before the test.
Practical Tips Before Your Test
Keep the following points in mind before submitting your sample.
- Bring a detailed clinical history, including your symptoms, previous test results, and family history, as this is required for the test.
- Carry all previous pathology reports, including biopsy or surgical histopathology reports, for reference.
- Inform the lab about any prior breast cancer treatments or surgeries.
- Check with the lab in advance whether your existing FFPE tissue block is available and suitable for testing.
Step-by-Step Procedure
The following steps describe how this test is carried out from sample identification to result dispatch.
- A pathologist reviews stained slides from the existing FFPE tumour tissue block and marks the region containing viable invasive breast cancer cells.
- Thin sections (typically 4 to 5 micrometres thick) are cut from the FFPE block, ensuring the sample contains at least 30% tumour cells.
- DNA is extracted and purified from the tissue sections using appropriate laboratory kits.
- The purified DNA is processed using droplet digital PCR, which partitions the reaction into approximately 20,000 individual droplets for highly sensitive gene copy number measurement.
- The HER2 gene copy number is calculated against a reference gene to determine whether the gene is amplified.
- Results are reviewed and interpreted by a qualified pathologist before the report is issued.
Factors That Can Affect Accuracy
Several factors may influence the reliability of the result.
- Low tumour cell content in the tissue sample
- Poor DNA quality due to inadequate tissue fixation
- Intratumoral heterogeneity, where cancer cells within the same tumour have different HER2 levels
- Skipping the enzyme digestion step in the ddPCR protocol may lead to inaccurate readings
- Incorrect selection of the reference gene used for comparison
Understanding Your HER2Neu by DD PCR (Ca Breast) Test Results
Your results will indicate whether the HER2 gene is amplified (positive) or not amplified (negative).
| Parameter | Reference Range |
|---|---|
| HER2 copy number (ddPCR) | HER2-Negative- Less than 3 copies HER2-Positive- 3 or more copies |
| HER2/CEP17 ratio | HER2-Negative-Less than 2.0 HER2-Positive- 2.0 or above with 4.0 or more average copy number |
These ranges are general guidelines. Your doctor will interpret your results based on your age, health history, and other factors. Always consult a qualified healthcare professional for personalised medical advice.
Results During Special Conditions
Certain situations may make interpretation more complex.
Sometimes a tumour has a mixture of cells, some of which are HER2-positive and some not, which can make results less accurate. Errors can also occur if the lab process is not performed correctly or if the sample contains too few cancer cells, which could affect the accuracy of the result.
How to Maintain Healthy Levels
The following are general wellness practices related to breast health.
- Practise regular breast self-examinations and follow your doctor's advice on mammography screening schedules.
- Maintain a healthy weight and stay physically active, as these are associated with better overall breast health.
- Discuss any family history of breast cancer with your doctor so that appropriate surveillance and testing can be planned.
Lupin Diagnostics HER2Neu By DD PCR (Ca Breast) Test Price
The HER2Neu by DD PCR test is priced starting at ₹12,000 at Lupin Diagnostics. This test requires a visit to a Lupin Diagnostics centre or submission of an FFPE tissue block through your treating doctor; home collection is not available for this test.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 12000 |
| CHENNAI | 12000 |
| HYDERABAD | 12000 |
| KOLKATA | 12000 |
| NAVI MUMBAI | 12000 |
| PUNE | 12000 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Follow these steps to book your Her2Neu by DD PCR test at Lupin Diagnostics.
- Select the test on the Lupin Diagnostics website.
- Choose your city and preferred centre location.
- Visit the centre at your scheduled time for sample submission, or coordinate with your doctor to arrange FFPE block dispatch.
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
This test uses Droplet Digital PCR technology to measure the number of HER2 gene copies in breast tumour tissue. It helps determine whether a breast cancer is HER2-positive, which is an important factor in planning treatment. The test is ordered by an oncologist or pathologist after a breast cancer diagnosis.
Droplet Digital PCR provides absolute gene copy number counts without needing calibration curves, unlike conventional methods. It is more sensitive and has lower quantitative variability, making it particularly useful when standard FISH results are unclear or equivocal.
HER2-positive cancers tend to grow more quickly than HER2-negative cancers. Knowing your HER2 status helps your doctor decide whether you are a candidate for targeted therapies designed to work against HER2-driven tumours. This information directly affects your treatment plan.
The test uses preserved tumour tissue from a biopsy or surgical specimen that has already been collected. If you have an existing FFPE tissue block from a prior procedure, no new sample collection is typically needed. Your doctor or the lab will advise you on how to arrange the block transfer.
At Lupin Diagnostics, the report is delivered within 12 days. This accounts for the time required to process the FFPE block, extract DNA, run the ddPCR assay, and interpret the results in a specialised molecular pathology laboratory.
HER2 is overexpressed in approximately 15 to 20% of invasive breast carcinomas. This is why the HER2Neu by DD PCR test is considered essential for all newly diagnosed invasive breast cancer patients, regardless of tumour stage or grade.
No. The Her2Neu by DD PCR test procedure requires an FFPE tumour tissue block that must be processed in a specialised molecular pathology laboratory. Home collection is not applicable for this test. Please visit a Lupin Diagnostics centre or coordinate with your doctor for sample submission.
HER2Neu By DD PCR (Ca Breast) Test: Booking, Price, and Results
