Oncomine Focus Panel + PDL1 Test
About Oncomine Focus Panel + PDL1 Test
| Field | Value |
|---|---|
| Also Known As | Oncomine Focus Assay + PD-L1 IHC, OFA + PDL1, Oncomine 52-Gene Panel with PD-L1, NGS Focus Panel with Immunohistochemistry |
| Sample Type | FFPE (formalin-fixed paraffin-embedded) tumour tissue block |
| Fasting Required | No |
| Report Time | 26 days |
| Recommended For | Adults with diagnosed solid tumours requiring treatment guidance |
| Price | Starting at ₹42,000 |
What Is an Oncomine Focus Panel + PDL1 Test?
The Oncomine Focus Panel + PDL1 test is a specialised molecular profiling test used in cancer care. It uses next-generation sequencing (NGS) to analyse tumour tissue for cancer-driving gene changes and immune marker expression. Oncologists use this test to identify whether a patient may benefit from targeted therapies or immunotherapy drugs. The sample required is a formalin-fixed, paraffin-embedded (FFPE) tumour tissue block obtained from a biopsy or surgical procedure. It is also known as Oncomine focus assay + PD-L1 IHC, OFA + PDL1, Oncomine 52-gene panel with PD-L1, or NGS focus panel with immunohistochemistry.
What Does an Oncomine Focus Panel + PDL1 Test Measure?
This test analyses tumour tissue for two distinct categories of cancer-relevant information. The following genes are screened by the Oncomine Focus Panel + PDL1 test procedure:
| Gene Category | Genes Included |
|---|---|
| Hotspot mutations | AKT1, ALK, AR, BRAF, CDK4, CTNNB1, DDR2, EGFR, ERBB2, ERBB3, ERBB4, ESR1, FGFR2, FGFR3, GNA11, GNAQ, HRAS, IDH2, JAK1, JAK2, JAK3, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, PDGFRA, PIK3CA, RAF1, RET, ROS1, SMO; single-letter DNA changes or small insertions/deletions at known cancer hotspots |
| Copy number variations (CNVs) | ALK, AR, BRAF, CCND1, CDK4, CDK6, EGFR, ERBB2, FGFR1, FGFR2, FGFR3, FGFR4, KIT, KRAS, MET, MYC, MYCN, PDGFRA, PIK3CA; abnormal extra copies of genes that can drive tumour growth |
| Gene fusions | ABL1, AKT1, AXL, ALK, BRAF, ERBB2, ERG, ETV1, ETV4, ETV5, FGFR1, FGFR2, FGFR3, NTRK1, NTRK2, NTRK3, PDGFRA, PPARG, RAF1, RET, ROS1; abnormal joining of two genes that creates cancer-driving proteins |
| Exon skipping | EGFR, MET; missing segments within a gene that alter how the protein functions |
| PD-L1 expression | Measured as Tumour Proportion Score (TPS) and Combined Positive Score (CPS), indicating how much PD-L1 protein is present on tumour and immune cells |
Why Is an Oncomine Focus Panel + PDL1 Test Done?
This test is ordered when an oncologist needs a detailed genetic profile of a patient's tumour to plan treatment.
Common Symptoms That May Require This Test
Several clinical findings may prompt an oncologist to request the Oncomine Focus Panel + PDL1 test:
- Unexplained, persistent weight loss alongside a confirmed or suspected tumour
- Persistent cough or breathing difficulties in a patient with suspected lung cancer
- A tumour detected on imaging that requires further characterisation
- Diagnosis of advanced or metastatic solid cancer
- Cancer that has returned after previous treatment
- Resistance to ongoing treatment with no clear explanation
- New or worsening symptoms in a patient already on cancer therapy
Conditions This Test Can Help Detect
This test is used across a wide range of solid tumour types. It can identify actionable genetic changes in the following cancers:
- Lung cancer (including non-small cell lung cancer)
- Breast cancer
- Colorectal cancer
- Melanoma
- Gastric and oesophageal cancer
- Head and neck cancers
- Thyroid cancer
- Prostate cancer
- Cholangiocarcinoma (bile duct cancer)
- Urothelial carcinoma
- Sarcomas (bone and uterine)
- Salivary gland carcinoma
How to Prepare and What to Expect
No special physical preparation is needed for this test, as it uses existing tumour tissue rather than a new blood or urine sample.
Do You Need to Fast?
No fasting is required. This test analyses tumour tissue rather than blood, so food and drink intake do not affect the sample. Always follow specific instructions provided by your doctor.
Practical Tips Before Your Test
A few steps will help ensure the sample is suitable for analysis:
- Bring a detailed clinical history, including your symptoms, previous test results, and family history, as this is required for the test
- Confirm that your previous biopsy or surgical tumour tissue block is accessible from the hospital or pathology archive
- Provide the original histopathology report alongside your tissue sample
- Inform the laboratory if you have received prior chemotherapy or radiotherapy, as this can affect tissue quality
Step-by-Step Procedure
The following steps outline how the Oncomine Focus Panel + PDL1 test procedure works:
- A qualified medical professional collects a tumour sample through a biopsy. This may be a core needle biopsy (often guided by CT or ultrasound for internal tumours), a fine-needle aspiration, a surgical excision, or an endoscopic biopsy, depending on the tumour's location. The procedure is performed at a hospital or clinic.
- The collected tissue is placed in formalin, a preservative solution that stops cellular activity and stabilises the DNA, RNA, and proteins within the sample. After fixation, the tissue is dehydrated and embedded in paraffin wax to form an FFPE block.
- The FFPE tissue block is sent to the Lupin Diagnostics laboratory at ambient temperature (18-28°C).
- DNA and RNA are extracted from the tissue and prepared for NGS analysis using the Oncomine Focus Assay.
- The tissue section is separately stained to measure PD-L1 protein expression.
- Results from both analyses are processed by bioinformatics software and reviewed by a molecular pathologist.
- A detailed report covering all gene findings and PD-L1 scores is issued within 26 days.
Factors That Can Affect Accuracy
Certain conditions may affect how well the test performs:
- Low tumour cell content in the tissue sample (a minimum of 10 to 20% tumour cells is recommended)
- Poor tissue fixation or prolonged storage of the tissue block
- Inadequate tissue quantity submitted to the laboratory
- Prior cancer treatments (chemotherapy, radiation) altering the tumour's genetic or protein profile
- Tissue from decalcified specimens, which is not suitable for this test
- Tumour heterogeneity, where different parts of the same tumour may show different PD-L1 expression
Understanding Your Oncomine Focus Panel + PDL1 Test Results
Results from this test are not reported as simple normal or abnormal values. They require interpretation by a qualified oncologist or molecular pathologist in the context of the patient's full clinical picture. The table below provides general reference results:
| Parameter | Result Categories | Interpretation |
|---|---|---|
| Gene Mutations (hotspot SNVs and indels) | Detected/Not Detected | Pathogenic variants reported with clinical significance |
| Copy Number Variations | Amplified/Normal | Significant amplifications were flagged where relevant |
| Gene Fusions | Detected/Not Detected | Actionable fusions identified and reported |
| Exon Skipping | Detected/Not Detected | Reported for EGFR and MET |
| PD-L1 Score | Result | Interpretation |
|---|---|---|
| TPS (Tumour Proportion Score) | <1% | Minimal or no PD-L1 expression on tumour cells. |
| 1–49% | Low-to-intermediate PD-L1 expression on tumour cells. | |
| ≥50% | High PD-L1 expression on tumour cells. | |
| CPS (Combined Positive Score) | <1 | Minimal or no PD-L1 expression on tumour and immune cells. |
| 1–9 | Low PD-L1 expression on tumour and immune cells. | |
| ≥10 | Moderate to high PD-L1 expression on tumour and immune cells. | |
| ≥20 | Very high PD-L1 expression on tumour and immune cells. |
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 alter how results are interpreted:
- Tissue older than five years has a higher likelihood of test failure, particularly for RNA-based fusion analysis.
- Prior chemotherapy or radiation may damage tumour DNA, affecting the reliability of variant detection.
- Tumour heterogeneity means results from one biopsy site may not reflect mutations present elsewhere in the tumour.
- A high PD-L1 score does not guarantee that immunotherapy will be effective, as only a proportion of patients with high expression respond to immune checkpoint inhibitors.
How to Maintain Healthy Levels
This is a diagnostic test performed in the context of cancer treatment planning. The following points may be useful for patients awaiting or receiving results:
- Follow your oncologist's guidance on the next steps once results are available
- Keep all previous biopsy reports, imaging results, and treatment records organised for your clinical consultations
- Ask your oncologist to explain which specific mutations or PD-L1 scores are relevant to your treatment options
Lupin Diagnostics Oncomine Focus Panel + PDL1 Test Price
The Oncomine Focus Panel + PDL1 test cost at Lupin Diagnostics starts at ₹42,000. This test requires a visit to a hospital or submission of an archived tissue block to the Lupin Diagnostics centre; home collection is not available for this test. The table below shows indicative prices:
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 42000 |
| CHENNAI | 42000 |
| HYDERABAD | 42000 |
| KOLKATA | 42000 |
| NAVI MUMBAI | 42000 |
| PUNE | 42000 |
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 for Oncomine Focus Panel + PDL1 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, or coordinate with the laboratory to arrange tissue block submission through your treating hospital or oncologist.
- Receive your report via email or WhatsApp within 26 days of sample acceptance.
Frequently Asked Questions
The Oncomine Focus Panel + PDL1 test is a combined cancer molecular profiling test. It uses next-generation sequencing to detect mutations, gene amplifications, and fusions across a defined set of cancer-related genes and measures PD-L1 protein expression. Together, these results help oncologists decide whether targeted therapy or immunotherapy is appropriate.
This test is recommended for patients with a confirmed diagnosis of a solid tumour who need guidance on targeted therapy or immunotherapy options. It is commonly ordered for lung cancer, colorectal cancer, melanoma, gastric cancer, breast cancer, and other advanced solid tumours.
The test uses an FFPE tumour tissue block obtained from a prior biopsy or surgical procedure. No new tissue collection is required from the patient. The block is submitted to the laboratory along with the accompanying histopathology report and a detailed clinical history.
The turnaround time for the Oncomine Focus Panel + PDL1 test at Lupin Diagnostics is 26 days. The report is delivered directly via email or WhatsApp.
No. This test requires tumour tissue obtained from a biopsy or surgical procedure, which must be collected in a hospital or clinic setting. The FFPE tissue block is then submitted to a Lupin Diagnostics centre for processing and analysis in a specialised molecular pathology laboratory.
PD-L1 expression is the most widely used predictive biomarker for immune checkpoint inhibitor therapy. High PD-L1 expression may indicate a greater likelihood of benefit from immunotherapy. However, not all patients with high expression respond, and some with low expression may still benefit. Your oncologist will consider PD-L1 results alongside other clinical factors before recommending treatment.
Oncomine Focus Panel + PDL1 Test
