IHC Marker - PDL-1(SP263, VENTANA) Test
About IHC Marker - PDL-1(SP263, VENTANA) Test
| Field | Value |
|---|---|
| Also Known As | PD-L1 IHC SP263 Test, PD-L1 (SP263) Ventana Test, Programmed Death-Ligand 1 Immunohistochemistry Test, PDL-1 SP263 Assay Test |
| Sample Type | FFPE Tissue Block (formalin-fixed, paraffin-embedded tumour tissue) |
| Fasting Required | No fasting required |
| Report Time | 7 Days |
| Recommended For | Adult men and women diagnosed with or suspected of having cancer, particularly lung, head and neck, bladder, or other solid tumours |
| Price | Starting at ₹4,200 |
What Is an IHC Marker - PDL-1(SP263, VENTANA) Test?
The IHC marker - PDL-1 test is a specialised laboratory test that detects the presence and level of a protein called PD-L1 (Programmed Death-Ligand 1) in tumour tissue. It is performed using immunohistochemistry (IHC), a technique that uses specific antibodies to identify proteins in tissue samples.
The SP263 clone runs on the VENTANA automated staining platform, making this a highly standardised assay. Oncologists order this test to help decide whether a cancer patient may benefit from a class of treatments known as checkpoint immunotherapy. It is also known as the PD-L1 (SP263) Ventana test or the PDL-1 SP263 Assay test.
What Does an IHC Marker - PDL-1(SP263, VENTANA) Test Measure?
The IHC marker - PDL-1(SP263, VENTANA) test analyses a single key protein and scores its presence using established methods. The table below summarises what is assessed.
| What Is Measured | Why It Matters |
|---|---|
| PD-L1 protein expression on tumour cells and immune cells | Indicates how likely the tumour is to respond to PD-1/PD-L1 targeted immunotherapy |
| Tumour Proportion Score (TPS) | Percentage of tumour cells showing PD-L1 staining; used to classify expression as negative, low, or high |
| Combined Positive Score (CPS) | Counts both tumour cells and immune cells expressing PD-L1; used for certain cancer types |
Why Is an IHC Marker - PDL-1(SP263, VENTANA) Test Done?
The IHC marker - PDL-1 test is not a screening test. It is ordered for patients already diagnosed with cancer to guide treatment planning, particularly decisions around immunotherapy.
Common Symptoms That May Require This Test
The PDL-1 SP263 Assay test is typically requested based on a cancer diagnosis rather than specific symptoms. The following situations commonly lead an oncologist to order it:
- Confirmed or suspected non-small cell lung cancer (NSCLC)
- Diagnosed bladder or urothelial carcinoma
- Head and neck squamous cell carcinoma requiring treatment planning
- Cervical, gastric, or esophageal cancer assessment
- Triple-negative breast carcinoma evaluation
- Recurrence of a previously treated solid tumour
- Reassessment before starting a new line of cancer treatment
Conditions This Test Can Help Assess
A doctor may order the PD-L1 (SP263) Ventana test when a patient has one of the following cancer types:
- Non-small cell lung cancer (NSCLC)
- Urothelial (bladder) carcinoma
- Cervical carcinoma
- Gastroesophageal and gastric carcinoma
- Esophageal squamous cell carcinoma
- Triple-negative breast carcinoma
- Head and neck squamous cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
How to Prepare and What to Expect
The IHC marker - PDL-1(SP263, VENTANA) test procedure involves a tissue sample obtained through biopsy or from previously collected tumour material. No special preparation is needed by the patient before submitting the sample.
Do You Need to Fast?
No fasting is required for this test. The sample used is a formalin-fixed, paraffin-embedded (FFPE) tissue block, not a blood or urine sample.
Practical Tips Before Your Test
Before submitting your tissue sample, keep the following in mind:
- Bring a detailed clinical history including your symptoms, previous test results, and relevant radiological details, as this is required for the test
- Carry your original histopathology report when submitting the FFPE block
- Inform your oncologist or surgeon about any allergies or current medications before any biopsy procedure
- Ensure that adequate tumour tissue is available for testing
- Follow all instructions given by your oncologist regarding how the biopsy sample should be handled and transported
Step-by-Step Procedure
The process from sample collection to result involves several stages. Here is what typically happens:
- A tissue sample is obtained through a biopsy (fine needle aspiration, core needle, or surgical biopsy) or from previously resected tumour tissue already preserved as an FFPE block.
- The tissue is fixed in formalin and embedded in paraffin to create the FFPE block, which is then sectioned into thin slides.
- The SP263 antibody is applied to the tissue slide. It binds to any PD-L1 protein present in the sample.
- The stained slide is processed on the automated VENTANA BenchMark ULTRA platform using the OptiView DAB IHC Detection Kit.
- A qualified pathologist examines the stained slide under a microscope and scores PD-L1 expression.
- The scored result, along with the clinical history provided, is compiled into a report and delivered within 7 days.
Factors That Can Affect Accuracy
Several factors may influence the reliability of the test result:
- Age of the FFPE block (fresher samples generally produce more reliable staining)
- Quality and adequacy of the tissue sample collected during biopsy
- Fixation method used (formalin fixation is required; alcohol-based fixation can affect staining quality)
- Natural variation in PD-L1 expression within and across different parts of the same tumour
- Technical handling during the biopsy or sample preparation process
Understanding Your IHC Marker - PDL-1(SP263, VENTANA) Test Results
Results are scored by a pathologist and reported as a percentage of cells expressing PD-L1. Always review your results with your treating oncologist, who will interpret them alongside your full clinical picture.
| PD-L1 Expression Level | Interpretation | Scoring Method |
|---|---|---|
| Less than 1% of tumour cells (TC) | Negative / Low expression | TPS (Tumour Proportion Score) |
| 1% to less than 25% TC | Low expression | TPS |
| 25% TC or more | High expression (relevant for some drugs, e.g., durvalumab) | TPS |
| 50% TC or more | High expression (relevant for some drugs, e.g., cemiplimab) | TPS |
Disclaimer: These ranges are general guidelines. Your doctor will interpret your results based on your cancer type, treatment plan, and overall health history. Always consult a qualified healthcare professional for personalised medical advice.
Results During Special Conditions
Certain factors specific to this test can affect how results should be read:
PD-L1 expression can vary between different areas of the same tumour and between the primary tumour and its spread (metastases). A sample taken from one site may not fully reflect expression across the entire tumour.
The fixation method used during tissue processing also affects staining. Samples fixed in formalin give the most reliable results. If alcohol-based fixation was used, the staining quality may be reduced, and results should be interpreted with caution.
Navigating Your Diagnostic Results
This is an oncology diagnostic test and PD-L1 expression cannot be altered through lifestyle changes. The following general steps are recommended:
- Discuss your results with your oncologist before making any treatment decisions
- Ask your doctor to explain your score and what it means for your specific cancer type and stage
- Seek a second pathology opinion if your results are borderline or the interpretation is unclear
Lupin Diagnostics IHC Marker - PDL-1(SP263, VENTANA) Test Price
The IHC marker - PDL-1 test cost at Lupin Diagnostics starts at ₹4,200. This test requires an FFPE tissue block obtained during a biopsy or surgical procedure. The tissue specimen can then be submitted to a Lupin Diagnostics laboratory for analysis.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 4200 |
| CHENNAI | 4200 |
| HYDERABAD | 4200 |
| KOLKATA | 4200 |
| NAVI MUMBAI | 4200 |
| PUNE | 4200 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Booking your IHC marker - PDL-1 test online through Lupin Diagnostics is straightforward:
- Select the test on the Lupin Diagnostics website
- Choose your city and preferred centre location
- Complete the booking process and follow the instructions provided for submitting the FFPE tissue block and required documents
- Receive your report via email or WhatsApp within 7 days
Frequently Asked Questions
This test measures PD-L1 protein expression in tumour tissue to help oncologists decide whether immunotherapy is a suitable treatment option. It is ordered after a cancer diagnosis, not as a routine screening test.
The sample is a formalin-fixed, paraffin-embedded (FFPE) tissue block. This is obtained through a biopsy procedure (such as a fine needle aspiration, core needle biopsy, or surgical biopsy) or from tumour tissue that was previously removed during surgery.
A positive result means PD-L1 protein was detected in the tissue sample at measurable levels. Depending on the score and the cancer type, this may indicate that the patient could benefit from immunotherapy drugs that target the PD-1/PD-L1 pathway. Your oncologist will explain what the result means for your specific situation.
Different PD-L1 clones are matched to specific drugs and cancer types. The SP263 assay runs on the VENTANA platform and is indicated for identifying patients with certain cancers for treatment with specific immunotherapy agents. Because each clone has unique staining patterns and interpretation guidelines, they should not be used interchangeably.
For most patients, the experience involves submitting an existing FFPE tissue block collected during an earlier biopsy or surgery. If a new biopsy is needed, the procedure will depend on the tumour location. Your oncologist or surgeon will explain what to expect before any tissue collection.
At Lupin Diagnostics, the report is delivered within 7 days of sample receipt. Turnaround time may vary slightly depending on sample quality and the volume of tests being processed at the time.
No. The IHC marker - PDL-1 test requires the submission of a tissue block, which must be handled, processed, and analysed in a laboratory setting. Home collection is not available for this test. Please visit your nearest Lupin Diagnostics centre to submit your sample.
IHC Marker - PDL-1(SP263, VENTANA) Test
