EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test: Booking, Price, and Results
About EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test: Booking, Price, and Results
| Field | Value |
|---|---|
| Also Known As | EGFR Mutation Analysis, EGFR Gene Test, EGFR Exon 18 to 21 Analysis, EGFR Molecular Testing on FFPE Block |
| Sample Type | Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue block |
| Fasting Required | No fasting required |
| Report Time | 8 days |
| Recommended For | Adult patients diagnosed with non-small cell lung cancer (NSCLC), particularly adenocarcinoma; males and females |
| Price | Starting at ₹7,840 |
What is an EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test?
The EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test analyses tumour tissue to identify specific mutations in the EGFR (Epidermal Growth Factor Receptor) gene. EGFR is a gene that controls how cells grow and divide. When it carries certain mutations, it can drive the growth of cancer cells.
This test is ordered for patients already diagnosed with non-small cell lung cancer (NSCLC) to determine whether targeted therapies may be effective. The sample used is a preserved tissue block from a previous biopsy or surgical procedure, not a fresh blood draw.
What Does an EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test Measure?
The EGFR Mutation Detection test uses Real Time PCR technology to look for specific mutations across four key regions (exons) of the EGFR gene. Each exon can carry mutations with different clinical meanings.
| Exon | Mutations Detected | Significance |
|---|---|---|
| Exon 18 | G719A, G719C, G719S | Rare sensitising mutations; may respond to targeted therapy |
| Exon 19 | Deletions | Most common EGFR mutations; strongly associated with response to TKI therapy |
| Exon 20 | T790M, S768I, insertions | T790M indicates resistance to first and second-generation TKIs |
| Exon 21 | L858R, L861Q | L858R is one of the most frequent mutations; associated with TKI sensitivity |
TKI stands for tyrosine kinase inhibitor, a type of targeted drug that blocks signals telling cancer cells to grow.
Why is an EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test Done?
Oncologists order this test to guide treatment decisions for lung cancer patients. The result helps confirm whether a patient is likely to benefit from specific targeted therapies.
Common Symptoms That May Require This Test
This test is not ordered based on symptoms alone. It is ordered after a lung cancer diagnosis has already been confirmed. The symptoms that typically lead to diagnosis include:
- Persistent cough that does not resolve
- Chest pain or tightness
- Shortness of breath
- Unexplained weight loss
- Coughing up blood
- Recurring respiratory infections
- Unusual fatigue
Conditions This Test Can Help Detect
The EGFR Mutation Detection test helps identify specific mutation profiles in confirmed cancer cases. It is relevant in the following situations:
- Non-small cell lung cancer, particularly adenocarcinoma
- Adenosquamous carcinoma of the lung (less commonly)
- Identifying eligibility for EGFR-targeted therapy
- Confirming resistance to first or second-generation TKI therapy
- Assessing acquired T790M mutation following disease progression
EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test for Chronic Disease Monitoring
This test may be repeated during the course of treatment to check whether the cancer has developed new mutations that cause resistance to the current therapy. Patients whose disease progresses while on TKI therapy are commonly re-tested for the acquired T790M mutation. Repeat testing supports informed decisions about switching or adjusting treatment strategies.
How to Prepare and What to Expect
No fasting or special physical preparation is required for this test. However, the quality of the tissue sample is critical for an accurate result.
Do You Need to Fast?
No fasting is needed. This test does not involve a blood draw, so food and drink before the test are not a concern.
Practical Tips Before Your Test
Being prepared with the right documentation and sample details will help avoid delays. Keep the following in mind:
- Bring a detailed clinical history including your symptoms, previous test results, and family history, as this is required for the test
- Bring your histopathology report, as this is also required for the test
- Inform your oncologist about any prior chemotherapy, radiation, or targeted therapy you have received
- Confirm that the FFPE tissue block contains at least 10% tumour cells, as lower tumour content may affect the result
- Ensure the tissue was fixed in 10% neutral buffered formalin for 6 to 72 hours
- Pathology reports should accompany the tissue specimen when submitting to the lab
Step-by-Step Procedure
The following steps describe how this EGFR Mutation Detection test is carried out using an FFPE tissue block:
- The FFPE tissue block from a previous biopsy or surgical procedure is submitted to the laboratory along with clinical history and the histopathology report.
- A pathologist reviews the tissue under a microscope to confirm adequate tumour content (a minimum of 10% tumour cells is required).
- Thin tissue sections are cut from the block using a precision instrument called a microtome, and tumour cells are collected into tubes.
- DNA is extracted from the tumour tissue using specialised laboratory kits.
- Real Time PCR is performed: target DNA segments are amplified and detected using fluorescent probes that signal the presence of specific mutations.
- The results are analysed and an interpretive report is prepared, typically available within 8 days.
Factors That Can Affect Accuracy
Several factors can influence the reliability of the EGFR Mutation Detection result:
- Low tumour cell content in the tissue sample (below 10%)
- Inadequate formalin fixation time or poor formalin quality
- Degraded DNA in older tissue blocks
- Prior chemotherapy or radiation affecting tumour cell composition
- Mutations present below the detection threshold of the assay
Understanding Your EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test Results
This is a qualitative test. Results are reported as positive (mutation detected) or negative (no mutation detected), not as a numerical value. Your oncologist will interpret the finding alongside your full clinical picture.
| Result | Description | Clinical Meaning |
|---|---|---|
| Negative | No mutation detected | Wild-type EGFR; tumour less likely to respond to EGFR-targeted TKI therapy |
| Positive: Sensitising mutation (e.g., exon 19 deletion, L858R) | Mutation detected | Tumour likely to respond to EGFR-targeted TKI therapy |
| Positive: Resistance mutation (e.g., T790M, exon 20 insertion) | Mutation detected | Tumour may be resistant to first or second-generation TKIs |
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
When tumour content in the submitted sample is very low, the test may report "no mutation detected" even though a mutation is present in a small number of tumour cells. This is a limitation of detection sensitivity, not necessarily a true negative.
Prior chemotherapy or radiation can alter tumour composition and affect how reliably mutations are identified. Your oncologist will account for these factors when reviewing the result.
How to Maintain Healthy Levels
This test does not have numerical values to maintain. The following are general guidance points for patients going through this process:
- Keep all follow-up appointments with your oncologist to monitor how treatment is progressing
- Report any new or worsening symptoms to your healthcare team promptly
- Follow your oncologist's guidance regarding targeted therapy options based on your mutation profile
Lupin Diagnostics EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test Price
The EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test is priced starting at ₹7,840 at Lupin Diagnostics. This test requires a visit to a Lupin Diagnostics centre; home collection is not available for this test.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 7840 |
| CHENNAI | 7840 |
| HYDERABAD | 7840 |
| KOLKATA | 7840 |
| NAVI MUMBAI | 7840 |
| PUNE | 7840 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Booking your EGFR Mutation Detection test at Lupin Diagnostics is straightforward:
- 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, bringing your FFPE tissue block, clinical history, and histopathology report.
- Receive your report via email or WhatsApp within 8 days.
Frequently Asked Questions
The EGFR Mutation Detection test identifies specific mutations in the EGFR gene within lung tumour cells. The result helps oncologists decide whether EGFR-targeted therapies are likely to be effective for a particular patient's cancer.
This test is ordered after a confirmed diagnosis of non-small cell lung cancer, especially adenocarcinoma. International oncology guidelines recommend EGFR Mutation Detection for all patients with advanced NSCLC before starting treatment.
No new procedure is usually needed. The test uses a preserved tissue block from a biopsy or surgery the patient has already undergone. The FFPE tissue block is submitted to the laboratory along with the required clinical documents.
At Lupin Diagnostics, the report is available within 8 days. Turnaround time can vary slightly depending on sample quality and laboratory processing.
Yes. EGFR mutations are found at a higher rate in Asian patients compared to other populations. They are also more common in women and in people who have never smoked. This pattern makes EGFR testing particularly relevant for lung cancer patients in India.
A T790M mutation is typically a resistance mutation. It often develops after a patient has been on first or second-generation TKI therapy. Your oncologist will use this information to consider alternative treatment options suited to this mutation profile.
Yes, in some cases. If the tissue sample has very few tumour cells or if a mutation exists below the test's detection limit, the result may read as negative despite a mutation being present. Your oncologist will consider this possibility and may recommend further evaluation if clinically needed.
EGFR Mutation Detection (Exons -18, 19, 20, 21), FFPE Tissue Test: Booking, Price, and Results
