BRAF V600E Mutation, FFPE Tissue Test: Booking, Price, and Results
About BRAF V600E Mutation, FFPE Tissue Test: Booking, Price, and Results
| Field | Value |
|---|---|
| Also Known As | BRAF Gene Mutation Analysis, BRAF V600E Somatic Mutation Analysis, BRAF Mutation Test |
| Sample Type | Formalin-fixed paraffin-embedded (FFPE) tumour tissue block or unstained slides |
| Fasting Required | No fasting required |
| Report Time | 8 days |
| Recommended For | Cancer patients of any age or gender diagnosed with or suspected of melanoma, thyroid cancer, colorectal cancer, or other BRAF-associated malignancies |
| Price | Starting at ₹6,500 |
What is a BRAF V600E Mutation, FFPE Tissue Test?
The BRAF V600E Mutation, FFPE tissue test checks a sample of tumour tissue for a specific change in the BRAF gene known as the V600E mutation. The BRAF gene normally controls how cells grow and divide. When this mutation is present, the resulting protein becomes overactive and may drive uncontrolled cell growth. Oncologists order this test to guide treatment decisions, particularly to assess whether a patient may respond to BRAF-targeted therapies. It is also known as BRAF Gene Mutation Analysis or BRAF V600E Somatic Mutation Analysis.
What Does a BRAF V600E Mutation, FFPE Tissue Test Measure?
This test analyses tumour DNA extracted from preserved tissue to determine whether the V600E variant of the BRAF gene is present. The following points explain what the test evaluates.
- BRAF gene status: The BRAF gene produces a protein involved in signalling cells to grow. The V600E change is the most common BRAF mutation found in solid tumours, accounting for roughly 90% of all BRAF mutations identified.
- Mutation detection: The test uses Real Time PCR (a technique that amplifies and analyses DNA) to identify whether the V600E mutation is present or absent in the tumour sample.
- Qualitative result: This is not a numeric measurement. The result is reported simply as "Detected" or "Not Detected."
Why is a BRAF V600E Mutation, FFPE Tissue Test Done?
Doctors request the BRAF V600E Mutation test for several reasons related to cancer diagnosis and treatment planning.
Common Symptoms That May Require This Test
This test is not ordered based on symptoms alone. It is requested after a cancer diagnosis has been made or is strongly suspected. The following situations commonly prompt the test.
- A confirmed or suspected diagnosis of melanoma (skin cancer)
- Diagnosis of papillary or anaplastic thyroid cancer
- Diagnosis of colorectal cancer, especially in cases where Lynch syndrome needs to be ruled out
- Diagnosis of hairy cell leukaemia
- Any solid tumour where BRAF-targeted therapy is being considered
- Tumour relapse or change in disease course requiring reassessment of treatment options
Conditions This Test Can Help Detect or Evaluate
The BRAF mutation test is relevant across several cancer types. The following conditions are commonly evaluated using this test.
- Melanoma (the V600E mutation is found in 50 to 60% of cases)
- Papillary thyroid carcinoma (mutation present in approximately 40 to 70% of cases)
- Hairy cell leukaemia (mutation detected in over 85% of cases)
- Colorectal cancer (present in 8 to 15% of metastatic cases)
- Ovarian cancer, lung cancer, Langerhans cell histiocytosis, and Erdheim-Chester disease
How to Prepare and What to Expect
Because this test uses tumour tissue rather than a blood or urine sample, the preparation process is different from a routine laboratory test.
Do You Need to Fast?
No fasting is required for this test. The sample is a preserved tumour tissue block or slides from a previous biopsy, not a blood sample collected on the day of testing.
Practical Tips Before Your Test
Please keep the following points in mind before submitting your sample for the BRAF V600E Mutation, FFPE tissue test.
- Bring a detailed clinical history report, including your symptoms, previous test results, and family history, as this is required for the test.
- Ensure that the FFPE tissue block or unstained slides come from a biopsy that was fixed in 10% neutral buffered formalin for at least 6 hours (48 to 72 hours is preferred).
- Store FFPE blocks and slides at room temperature (15 to 25°C) and avoid exposure to extreme heat or moisture.
- A pathology report (final or preliminary) should accompany the specimen when it is submitted for testing.
- Inform your doctor about any prior cancer treatments or biopsies, as these details help the laboratory interpret results accurately.
Step-by-Step Procedure
The process for this test differs from a standard blood draw. Here is what typically happens.
- Your doctor obtains tumour tissue through a biopsy or surgical procedure. In many cases, tissue already collected during a previous biopsy may be used.
- The tissue is preserved using formalin and embedded in paraffin wax to create an FFPE block. This block or unstained slides prepared from it are submitted to the laboratory.
- A pathologist examines the tissue to confirm there is sufficient tumour content (ideally at least 50% tumour cells) for reliable DNA analysis.
- Laboratory specialists extract DNA from the tumour cells within the tissue sample.
- The extracted DNA is analysed using Real Time PCR to detect the presence or absence of the BRAF V600E mutation.
- The final report is generated and sent to your doctor, typically within 8 days of sample receipt.
Factors That Can Affect Accuracy
Several factors can influence the reliability of the BRAF V600E Mutation test procedure. These include the following.
- Using tissue fixed in non-standard fixatives (other than 10% neutral buffered formalin) may interfere with DNA quality.
- Tissue with less than 20% tumour cell content may yield unreliable results.
- Decalcification of bone tissue samples can damage DNA and may cause the PCR test to fail.
- High levels of necrotic (dead) or fatty tissue in the sample can reduce test accuracy.
- Rare genetic differences (polymorphisms) in the surrounding DNA could occasionally produce false-positive or false-negative results.
Understanding Your BRAF V600E Mutation, FFPE Tissue Test Results
Your doctor will review the result alongside your full clinical picture, including pathology findings and cancer type. The table below shows how results are generally interpreted.
| Result | Interpretation |
|---|---|
| Not Detected | The V600E mutation was not found. The BRAF gene appears normal (wild-type). The patient may not respond to BRAF-targeted therapies, and other treatment options will be considered. |
| Detected | The V600E mutation is present in the tumour. The patient may be eligible for BRAF inhibitor therapy, depending on cancer type and other clinical factors. |
Disclaimer: 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 circumstances can affect how results are read.
- Samples with low tumour content or mixed cell populations may carry a higher risk of false-negative results, since the current testing method can reliably detect the mutation only when it is present in at least 5% of the DNA in the sample.
- Poorly preserved FFPE tissue can lead to degraded DNA, which may affect the accuracy of the PCR analysis.
- Tissue areas with significant necrosis can produce unreliable results and may require a repeat biopsy or a fresh sample.
How to Maintain Healthy Levels
This test is a cancer diagnostic tool and not a wellness marker. The following general points are worth keeping in mind.
- Attend regular health check-ups and cancer screening appointments as recommended by your doctor.
- Follow your oncologist's guidance on treatment, follow-up intervals, and any additional molecular testing.
- Keep all medical records, biopsy reports, and imaging results organised so your care team has a complete picture of your health.
Lupin Diagnostics BRAF V600E Mutation, FFPE Tissue Test Price
The BRAF V600E Mutation test is priced starting at ₹6,500 at Lupin Diagnostics. This test requires a visit to a Lupin Diagnostics centre or submission of your FFPE tissue block through your treating doctor or hospital; home collection is not available for this test.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 7800 |
| CHENNAI | 7800 |
| HYDERABAD | 7800 |
| KOLKATA | 7800 |
| NAVI MUMBAI | 7800 |
| PUNE | 7800 |
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 the BRAF V600E Mutation test online or at a centre.
- Select the test on the Lupin Diagnostics website.
- Choose your city and preferred centre location.
- Visit the centre at your scheduled time, or arrange submission of your FFPE tissue block through your treating doctor.
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
The BRAF gene controls how your cells are told to grow and divide. The V600E mutation causes the BRAF protein to become constantly active, which can lead to uncontrolled cell growth and cancer. Knowing whether this mutation is present helps your oncologist choose the most appropriate treatment, including specific targeted therapies designed to block the abnormal protein.
This test is recommended for patients diagnosed with certain cancers, including melanoma, papillary thyroid carcinoma, colorectal cancer, and hairy cell leukaemia. Your oncologist will order it to determine whether you are a candidate for BRAF-targeted therapy or to help clarify a diagnosis.
The sample is a tumour tissue block or unstained slides from a biopsy or surgical procedure. In most cases, tissue already collected during a previous biopsy can be submitted for testing, so no new procedure may be needed. The FFPE tissue block is prepared by a pathologist and sent to the laboratory.
No. The BRAF V600E Mutation test home collection option is not available because the sample is a tumour tissue block, not a blood or urine sample. FFPE blocks or slides need to be submitted through your doctor, hospital, or a Lupin Diagnostics centre.
A "Detected" result means the V600E mutation was found in your tumour sample. This does not change your cancer diagnosis on its own, but it indicates that you may be eligible for specific BRAF inhibitor drugs. Your oncologist will explain what this means for your treatment plan.
At Lupin Diagnostics, the report is typically available within 8 days of the laboratory receiving the sample. The exact turnaround may vary depending on sample quality and the complexity of analysis required.
The BRAF V600E Mutation test cost varies depending on the laboratory and the method used. At Lupin Diagnostics, the test starts at ₹6,500. Prices across other laboratories in India can vary depending on whether PCR, immunohistochemistry, or next-generation sequencing is used.
BRAF V600E Mutation, FFPE Tissue Test: Booking, Price, and Results
