PIK3CA Mutation Analysis (Exons 7, 9 & 20) Test: Booking, Price, and Results
About PIK3CA Mutation Analysis (Exons 7, 9 & 20) Test: Booking, Price, and Results
| Field | Value |
|---|---|
| Also Known As | PIK3CA gene mutation test, PIK3CA mutation detection assay, PI3K mutation analysis, phosphatidylinositol 3-kinase catalytic subunit alpha mutation test |
| Sample Type | Formalin-fixed paraffin-embedded (FFPE) tumour tissue block |
| Fasting Required | No fasting required |
| Report Time | 15 days |
| Recommended For | Adults with diagnosed breast cancer, colorectal cancer, endometrial cancer, or other solid tumours where targeted therapy eligibility needs assessment |
| Price | Starting at ₹8,400 |
What Is a PIK3CA Mutation Analysis Test?
The PIK3CA mutation analysis test is a molecular genetic test that detects specific mutations in the PIK3CA gene within tumour tissue. This test is also known as the PIK3CA gene mutation test or PIK3CA mutation detection assay. It is ordered by doctors, typically oncologists, to help determine whether patients with certain cancers may benefit from targeted therapies. The sample used is a formalin-fixed paraffin-embedded (FFPE) tumour tissue block, typically obtained from a previous biopsy or surgical procedure.
What Does a PIK3CA Mutation Analysis Test Measure?
The PIK3CA mutation analysis test detects specific mutations in the PIK3CA gene, which are known to activate the PI3K/AKT/mTOR signalling pathway involved in cell growth, survival and proliferation.The table below explains what each part of the test assesses.
| Parameter | What It Measures |
|---|---|
| PIK3CA Mutation Status | Determines whether clinically significant mutations are present in the PIK3CA gene. |
| Exon 7 Analysis | Detects mutations associated with abnormal activation of cancer growth pathways. |
| Exon 9 Analysis | Detects common mutations linked to tumour growth and progression. |
| Exon 20 Analysis | Detects key mutations that may help guide targeted treatment decisions. |
Why Is a PIK3CA Mutation Analysis Test Done?
This test is not ordered based on symptoms. It is requested by a doctor after a cancer diagnosis to guide decisions about targeted treatment. The sections below explain which cancers and clinical situations typically call for this test.
Common Symptoms That May Require This Test
This test is not triggered by symptoms in the conventional sense. It is ordered based on clinical and pathological findings. The following situations typically lead a doctor to request a PIK3CA mutation analysis test:
- Diagnosis of hormone receptor-positive (HR+), HER2-negative advanced breast cancer
- Confirmed colorectal cancer requiring biomarker assessment
- Diagnosed endometrial or ovarian cancer being evaluated for targeted treatment
- Gastric (stomach) cancer under oncological review
- Glioblastoma or lung cancer requiring molecular profiling
- Evidence of resistance to standard endocrine therapy in breast cancer patients
Conditions This Test Can Help Detect
This test helps identify PIK3CA gene mutations in tumours linked to several cancer types. These include:
- Breast cancer, particularly the HR-positive, HER2-negative subtype
- Colorectal cancer
- Gastric (stomach) cancer
- Glioblastoma, an aggressive form of brain tumour
- Lung cancer
- Endometrial cancer and selected ovarian cancers
How to Prepare and What to Expect
No special preparation is required for this test, as it uses tumour tissue that has already been collected. However, a few practical steps will help the process go smoothly.
Do You Need to Fast?
No fasting is required. The PIK3CA mutation analysis test is performed on a tumour tissue block, not a freshly collected blood sample, so there are no dietary restrictions.
Practical Tips Before Your Test
Here are a few things to keep in mind before submitting your sample for testing:
- Provide any relevant clinical records, pathology reports, and previous test results requested by your doctor or laboratory.
- Ensure that the FFPE tumour tissue block from your biopsy or surgery is available and ready for submission.
- Confirm with the laboratory that the tissue sample meets the minimum tumour content requirement (at least 20% tumour nuclei).
- A copy of the pathology report should accompany the tissue specimen.
- Contact the laboratory in advance to confirm exact specimen requirements, as these may vary.
Step-by-Step Procedure
The tissue sample for this test is usually already collected from a prior biopsy or surgery. Here is how the testing process works:
- The FFPE tumour tissue block (paraffin block) from your biopsy or surgical procedure is sent to the laboratory along with your clinical history and pathology report.
- A pathologist examines the tissue under a microscope to identify tumour-rich areas suitable for testing.
- DNA is extracted from the identified tumour tissue.
- The laboratory uses validated molecular methods, such as PCR-based assays or sequencing technologies, to detect mutations in exons 7, 9, and 20 of the PIK3CA gene.
- The extracted DNA is analysed to identify the presence or absence of specific mutations.
- An interpretive report is generated and shared with your doctor, usually within 15 days.
Factors That Can Affect Accuracy
- Low tumour content in the tissue sample, which can lead to false-negative results.
- Poor quality or degradation of DNA, particularly in older archived tissue samples
- Inadequate tissue fixation or preservation.
- Rare technical or genetic factors may occasionally interfere with mutation detection and interpretation.
- Insufficient tumour nuclei (the assay requires at least 20% tumour nuclei in the sample).
Understanding Your PIK3CA Mutation Analysis Test Results
Your doctor will review the results of your PIK3CA mutation analysis test in the context of your overall cancer diagnosis, tumour characteristics, and treatment history. Results are reported as either mutation detected or not detected.
| Result | Interpretation |
|---|---|
| Not detected (wild-type) | No pathogenic PIK3CA mutation was identified in the analysed exons. This result does not completely exclude the presence of mutations outside the regions covered by the assay. |
| Detected (positive) | One or more pathogenic PIK3CA mutations were identified in the tumour tissue. Depending on the cancer type and clinical context, this may have implications for targeted treatment selection. |
Disclaimer: These interpretations 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
A few factors can affect how results should be interpreted:
- Low tumour content in the submitted tissue may reduce the sensitivity of the assay and increase the risk of a false-negative result.
- DNA degradation in older archived tissue samples can also affect accuracy, and a negative result does not entirely rule out mutations that fall outside the scope of this assay.
How to Maintain Healthy Levels
While this test does not have "normal levels" to maintain in the traditional sense, here are some general tips for supporting your well-being during cancer care:
- Maintain a balanced diet and stay physically active as tolerated, in line with your oncologist's guidance.
- Attend all scheduled oncology appointments to ensure your care plan remains current.
- Follow your oncologist's recommendations regarding additional genetic tests or treatment decisions based on your results.
Lupin Diagnostics PIK3CA Mutation Analysis Test Price
The PIK3CA mutation analysis test is priced starting at ₹8,400 at Lupin Diagnostics. This test requires a visit to a Lupin Diagnostics centre; home collection is not available for this test. The indicative prices in other cities are listed below for reference.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 8400 |
| CHENNAI | 8400 |
| HYDERABAD | 8400 |
| KOLKATA | 8400 |
| NAVI MUMBAI | 8400 |
| PUNE | 8400 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
- Select the PIK3CA mutation analysis (exons 7, 9 & 20) test on the Lupin Diagnostics website.
- Choose your city and preferred centre location.
- Visit the centre at your scheduled time to submit your FFPE tissue block along with the required clinical history and pathology report.
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
The PIK3CA mutation analysis test helps oncologists identify whether a patient has specific mutations in the PIK3CA gene. In patients with hormone receptor-positive, HER2-negative advanced breast cancer, a positive result may indicate eligibility for targeted therapy. Your doctor will use the findings to guide your treatment plan.
The sample is an FFPE tumour tissue block, which is a preserved piece of tumour obtained during a previous biopsy or surgical procedure. You do not need to undergo any additional sample collection for this test; the tissue from an earlier procedure is used.
Results for the test are typically available within 15 days. This timeline allows the laboratory to extract DNA from the tissue sample and carry out detailed sequencing and analysis.
No fasting is needed. Since this test is performed on a tumour tissue block rather than a freshly drawn blood or urine sample, there are no dietary or fluid restrictions before submission.
PIK3CA mutations are found across several cancer types, including breast, colorectal, lung, ovarian, gastric, and endometrial cancers, as well as glioblastoma. In colorectal cancer, PIK3CA mutations occur in approximately 10–25% of cases, with most located in exons 9 and 20.
A positive result means one or more PIK3CA mutations were detected in the tumour tissue. Depending on your cancer type, this may make you eligible for specific targeted therapies. Your oncologist will explain what the result means for your individual situation and discuss the next steps in your treatment.
In certain situations, the test can be performed on circulating tumour DNA (ctDNA) extracted from a blood sample, a method known as liquid biopsy. However, tissue-based testing using an FFPE block is the standard and generally preferred approach for accuracy. Speak to your doctor about which sample type is appropriate in your case.
PIK3CA Mutation Analysis (Exons 7, 9 & 20) Test: Booking, Price, and Results
