BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test
About BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test
| Field | Value |
|---|---|
| Also Known As | BRCA1/2 Somatic Mutation Analysis, Tumour BRCA Testing, NextGen BRCA Somatic Test, tBRCA Test |
| Sample Type | FFPE (Formalin-Fixed Paraffin-Embedded) tumour tissue block |
| Fasting Required | No |
| Report Time | 15 days |
| Recommended For | Cancer patients (breast, ovarian, prostate, pancreatic) being assessed for targeted therapy eligibility |
| Price | Starting at ₹14,500 |
What is a BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test?
The BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic test analyses tumour tissue for mutations in the BRCA1 and BRCA2 genes. These genes produce proteins that help repair damaged DNA in cells. When mutations occur within tumour tissue, they are called somatic mutations, meaning they arose in the cancer cells rather than being inherited.
This test is typically ordered by oncologists for patients already diagnosed with breast, ovarian, prostate, or pancreatic cancer. It helps determine whether a patient may respond to certain targeted therapies. The sample used is an FFPE tumour tissue block, usually from a prior biopsy or surgical procedure.
What Does a BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test Measure?
This test uses next-generation sequencing (NGS), a method that reads the DNA sequence in detail, to detect changes within the BRCA1 and BRCA2 genes. The findings are grouped into the following categories.
| Finding | Description |
|---|---|
| BRCA1 gene mutations | Changes in the BRCA1 gene that may disrupt DNA repair within tumour cells |
| BRCA2 gene mutations | Changes in the BRCA2 gene that may impair normal DNA repair mechanisms |
| Pathogenic variants | Mutations confirmed to disrupt gene function with clinical significance |
| Likely pathogenic variants | Mutations that are almost certainly harmful based on current evidence |
| Variants of uncertain significance (VUS) | Genetic changes where the clinical impact is not yet clearly understood |
Why is a BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test Done?
This test is not ordered based on symptoms. It is used to guide treatment decisions in patients who have already been diagnosed with certain cancers. Below is an overview of when it may be recommended.
Common Situations That May Require This Test
The following situations commonly lead an oncologist to request this test.
- Newly diagnosed ovarian cancer requiring treatment planning
- Breast cancer cases being evaluated for targeted therapy options
- Prostate cancer with advanced or metastatic disease
- Pancreatic cancer, where treatment options are being assessed
- Any cancer case where poly (ADP-ribose) polymerase (PARP) inhibitor therapy eligibility needs to be confirmed
- Prior biopsy or surgical tissue is available, and the mutation status is unknown
Conditions This Test Can Help Detect
The BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic test helps identify the following.
- Somatic BRCA1 or BRCA2 mutations in tumour tissue that may predict response to PARP inhibitor therapy
- Mutations associated with sensitivity to platinum-based chemotherapy
- Whether an identified mutation in tumour tissue is somatic (acquired in the tumour) rather than germline (inherited), which has different implications for the patient and their family
How to Prepare and What to Expect
Because this test uses tumour tissue rather than a fresh blood or urine sample, preparation is different from routine tests. The steps below explain what is involved.
Do You Need to Fast?
No fasting is required. This test does not use a blood or urine sample, so there are no dietary restrictions before submission.
Practical Tips Before Your Test
Keep the following points in mind before submitting the sample.
- Bring a detailed clinical history report, including your diagnosis, previous test results, and treatment history, as this is required for the test
- Confirm with your pathologist or surgeon that the FFPE block contains sufficient tumour tissue (a tumour cell content of at least 40% is generally recommended)
- Provide any available histopathology reports along with the block at the time of submission
- Note the age and storage conditions of the FFPE block, as older or poorly stored blocks may affect results
- If a somatic mutation is found, your doctor may recommend germline (blood-based) testing to determine whether the mutation is inherited
Step-by-Step Procedure for the BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test
The following steps describe how the sample is collected and processed.
- The FFPE tumour tissue block, preserved from a previous biopsy or surgical excision, is retrieved from the pathology laboratory where it is stored.
- The block, along with your clinical history and relevant reports, is submitted to the Lupin Diagnostics laboratory.
- The laboratory cuts thin sections from the FFPE block and extracts DNA from the tumour tissue.
- The extracted DNA is processed using next-generation sequencing (NGS) to read the BRCA1 and BRCA2 gene sequences in detail.
- A bioinformatics team analyses the sequencing data to identify any mutations and classify them.
- A detailed report is generated and delivered within the stated turnaround time.
Factors That Can Affect Accuracy
Several factors related to the tissue sample can influence the reliability of results.
- Age of the FFPE block (older blocks tend to have more fragmented DNA)
- Duration and quality of formalin fixation when the tissue was first preserved
- Low tumour cellularity, meaning a high proportion of normal cells within the sample
- Inadequate storage conditions of the tissue block before submission
- The presence of contaminating non-tumour DNA within the sample
Understanding Your BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test Results
Results from the BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic test are classified using the American College of Medical Genetics framework. Your oncologist will review the findings in the context of your overall diagnosis and treatment plan.
| Result Category | Meaning |
|---|---|
| No pathogenic mutation detected (Wild type) | No actionable BRCA1 or BRCA2 mutation was found in the tumour tissue |
| Pathogenic or likely pathogenic variant detected | A mutation known or strongly suspected to disrupt gene function was found; this may indicate eligibility for PARP inhibitor therapy |
| Variant of uncertain significance (VUS) | A genetic change was identified, but current evidence is insufficient to determine its clinical impact |
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 sample-related factors can affect how reliable the results are.
- FFPE tissue contains fragmented DNA. When the DNA quality is poor, some mutations may not be detected, or the test may need to be repeated with a better-quality sample.
- Low tumour cellularity, where the block contains more normal tissue than tumour tissue, can make it harder to detect somatic mutations accurately.
- Blocks that are several years old may yield degraded DNA, which can affect the completeness and accuracy of the sequencing results.
How to Maintain Healthy Levels
This test is specific to cancer patients and does not have "healthy levels" in the traditional sense. The following general guidance applies after receiving results.
- Discuss your results with your oncologist to understand what treatment options may be appropriate for your situation
- If a somatic BRCA mutation is detected, ask your doctor whether germline (blood-based) testing is recommended to check for inherited mutations
- Consider genetic counselling if mutations are found, particularly to understand any implications for close family members
Lupin Diagnostics BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test Price
The BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic test cost starts at ₹14,500 at Lupin Diagnostics. This test requires a visit to a Lupin Diagnostics centre or submission through a pathology lab. Home collection is not available because the test requires an FFPE tumour tissue block from a prior biopsy or surgical procedure.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 14500 |
| CHENNAI | 14500 |
| HYDERABAD | 14500 |
| KOLKATA | 14500 |
| NAVI MUMBAI | 14500 |
| PUNE | 14500 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
The following steps explain how to arrange your BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic test online booking.
- Select the test on the Lupin Diagnostics website.
- Choose your city and preferred centre location.
- Visit the centre at your scheduled time to submit the FFPE tissue block along with your clinical history and relevant reports.
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
Germline BRCA testing uses DNA from non-tumour cells, typically from a blood sample, and detects inherited mutations that a person is born with. Somatic BRCA testing, as done in the BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic test, analyses tumour tissue and looks for mutations that arose within the cancer cells. A somatic mutation is not inherited and cannot be passed to family members.
Tumour tissue preserved as an FFPE block from a previous biopsy or surgery directly contains the cancer cells being studied. Blood does not carry tumour DNA in quantities sufficient for this type of analysis. FFPE blocks are routinely stored in pathology laboratories, making them accessible for testing without requiring a new procedure.
The typical turnaround time at Lupin Diagnostics is 15 days. This includes DNA extraction, next-generation sequencing, and bioinformatics analysis. Your report will be delivered digitally once complete.
No. A somatic mutation develops within tumour cells and is not present in the rest of the body's cells. It cannot be inherited by or passed on to children. However, your doctor may still recommend germline testing to confirm this, particularly if you have a family history of related cancers.
A variant of uncertain significance (VUS) means a genetic change was found, but there is not yet enough scientific evidence to confirm whether it is harmful. No treatment decisions should be made based solely on a VUS result. Your doctor may recommend periodic re-evaluation as medical knowledge about specific variants continues to develop.
No fasting is required. The BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic test uses tumour tissue from a previously collected FFPE block, not a blood or urine sample. There are no dietary restrictions associated with this test.
A pathogenic mutation in the tumour may indicate that you could be eligible for PARP inhibitor therapy or platinum-based chemotherapy. Discuss these findings promptly with your oncologist. Your doctor may also recommend germline testing and refer you for genetic counselling to assess any implications for close family members.
BRCA 1 & 2 Gene Panel BY FFPE Block-Somatic Test
