IHC Marker - PDL-1(SP142, VENTANA) Test
About IHC Marker - PDL-1(SP142, VENTANA) Test
| Field | Value |
|---|---|
| Also Known As | VENTANA PD-L1 (SP142) Assay Test, PD-L1 IHC SP142 Test, PDL1 SP142 Test, CD274 IHC Test, B7-H1 IHC Test |
| Sample Type | FFPE Tissue Block (formalin-fixed, paraffin-embedded tumour tissue) |
| Fasting Required | No fasting required |
| Report Time | 7 days |
| Recommended For | Adults (male and female) diagnosed with certain cancers, particularly non-small cell lung cancer, urothelial carcinoma, and triple-negative breast cancer |
| Price | Starting at ₹5,000 |
What Is an IHC Marker - PDL-1(SP142, VENTANA) Test?
The IHC marker - PDL-1(SP142, VENTANA) test is a specialised laboratory test that detects the presence of PD-L1 (programmed death-ligand 1) protein in tumour tissue. It uses a technique called immunohistochemistry (IHC), which stains tissue samples to reveal specific proteins.
Doctors prescribe this test to assess whether a patient with certain cancers may respond to a type of treatment known as immunotherapy. The test is also referred to as the VENTANA PD-L1 (SP142) Assay test or the PD-L1 IHC SP142 test.
What Does an IHC Marker - PDL-1(SP142, VENTANA) Test Measure?
This test analyses a tumour tissue sample to measure how much PD-L1 protein is present and where it appears. PD-L1, also known as CD274 or B7-H1, is a protein that plays a role in controlling the body's immune response. The two key things this test evaluates are listed below.
| Component | What It Measures |
|---|---|
| Tumour Cell (TC) expression | The percentage of tumour cells showing PD-L1 protein at any intensity |
| Immune Cell (IC) expression | The proportion of the tumour area occupied by PD-L1-positive immune cells, including lymphocytes, macrophages, and dendritic cells |
Why Is an IHC Marker - PDL-1(SP142, VENTANA) Test Done?
Oncologists order the PD-L1 IHC SP142 test when they need to know whether PD-L1 protein is expressed in a patient's tumour, which can influence treatment decisions.
Common Symptoms That May Require This Test
A doctor may order this test when a patient with a known or suspected cancer reports the following symptoms:
- Unexplained or rapid weight loss
- Persistent cough or breathlessness
- Blood in urine
- A breast lump or change in breast tissue
- Persistent fatigue with no clear cause
- Bone pain in the context of a known cancer
- Shortness of breath
Conditions This Test Can Help Detect
The IHC marker - PDL-1 test is used to evaluate PD-L1 expression in patients with the following conditions:
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma (bladder cancer)
- Triple-negative breast cancer (TNBC)
- PD-L1 overexpression has also been observed in cancers of the colon, pancreas, ovary, kidney, and in melanoma
How to Prepare and What to Expect
No special physical preparation is needed for this test. However, there are a few important steps to follow before submitting your sample.
Do You Need to Fast?
No fasting is required for this test. The sample used is tumour tissue, not blood or urine, so dietary restrictions do not apply.
Practical Tips Before Your Test
The following steps will help ensure your sample is processed without delay:
- Bring a detailed clinical history, including your symptoms, previous test results, and family history
- Carry your original histopathology report from a prior biopsy or surgery, if available
- Inform the laboratory about the type and location of your cancer
- If you are undergoing a new biopsy, ensure at least two core biopsy samples are collected where clinically possible, as the assay requires a minimum of 50 viable tumour cells
Step-by-Step Procedure
The IHC marker - PDL-1 test procedure follows these steps:
- Tumour tissue is obtained through a biopsy, which may be a fine needle aspiration, core needle biopsy, or surgical biopsy, and submitted as an FFPE tissue block
- Tissue is fixed in formalin for 6 to 72 hours and then processed into a paraffin-embedded block
- Thin sections are cut from the block and placed on glass slides
- The VENTANA PD-L1 (SP142) assay applies a specialised rabbit monoclonal antibody that binds to any PD-L1 protein present in the tissue
- If PD-L1 is present, the tissue stains brown, and a qualified pathologist scores the staining in tumour cells and immune cells separately
- The tissue block is stored and transported at ambient temperature (18 to 28 degrees Celsius) and sent to the laboratory for analysis
Factors That Can Affect Accuracy
The following factors may influence the accuracy of your test result:
- Fixation time shorter than recommended, or use of non-standard fixatives, may cause false-negative results
- Slides should be stained within 2 to 3 months of being cut from the paraffin block, as PD-L1 antigenicity can reduce over time
- Tumour tissue varies in PD-L1 expression from one area to another, so a small biopsy sample may not reflect the full picture
- Prior treatment with chemotherapy or radiation may alter PD-L1 expression levels in the tumour
Understanding Your IHC Marker - PDL-1(SP142, VENTANA) Test Results
Results from this test are scored by a trained pathologist and should always be reviewed alongside your clinical history and other diagnostic findings. The table below shows the scoring cutoffs used for different cancer types.
| Cancer Type | Component Scored | Positive Cutoff |
|---|---|---|
| NSCLC | Tumour cells (TC) | 50% or more |
| NSCLC | Immune cells (IC) | 10% or more |
| Urothelial carcinoma | Immune cells (IC) | 5% or more |
| Triple-negative breast cancer | Immune cells (IC) | 1% or more |
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
The following factors may affect how results are interpreted:
- The SP142 clone tends to stain fewer cancer cells than other PD-L1 clones such as 22C3, SP263, and 28-8. This means it is not interchangeable with those assays, and each clone is validated for specific drugs and tumour types.
- Tumour heterogeneity, where PD-L1 expression varies across different parts of the tumour, may affect results when only a small biopsy sample is available. A negative result does not always rule out benefit from immunotherapy.
How to Maintain Healthy Levels
Because this is a companion diagnostic test, the concept of "healthy levels" does not apply in the conventional sense. The following points are worth keeping in mind:
- Regular health check-ups and age-appropriate cancer screening can help detect cancers at earlier, more treatable stages
- Discuss your full pathology report with your oncologist before any treatment decision is made
- Ask your doctor whether any other PD-L1 assay or additional biomarker testing is relevant to your specific cancer type
Lupin Diagnostics IHC Marker - PDL-1(SP142, VENTANA) Test Price
The IHC marker - PDL-1 test cost at Lupin Diagnostics starts at ₹5,000. 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 | 5000 |
| CHENNAI | 5000 |
| HYDERABAD | 5000 |
| KOLKATA | 5000 |
| NAVI MUMBAI | 5000 |
| PUNE | 5000 |
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 to book the IHC marker - PDL-1 test online:
- 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
The IHC marker - PDL-1 test detects PD-L1 protein expression in tumour tissue using immunohistochemistry. It is primarily used to help oncologists decide whether a patient with cancers such as NSCLC, urothelial carcinoma, or triple-negative breast cancer may benefit from atezolizumab immunotherapy.
The test requires a formalin-fixed, paraffin-embedded (FFPE) tissue block from the patient's tumour. This block is obtained through a biopsy or surgical procedure, or an existing block from a previous procedure may be submitted if it meets quality requirements.
No. The IHC marker - PDL-1 test requires a tumour tissue sample in the form of an FFPE tissue block. Home collection is not applicable for this type of sample.
A positive result means PD-L1 expression in the tumour meets or exceeds the clinical cutoff for a specific cancer type, suggesting the patient may benefit from certain immunotherapy drugs. A negative result means expression is below the cutoff, though some patients may still derive benefit from immunotherapy. Your oncologist will guide the next steps.
No. The SP142 clone is not interchangeable with other PD-L1 assay clones such as 22C3 or SP263. Each clone has different staining characteristics and is validated for specific drugs and tumour types. Using the wrong assay could lead to inaccurate treatment decisions.
Results for the IHC marker - PDL-1(SP142, VENTANA) test are typically available within 7 days of the laboratory receiving the tissue block. Timelines may vary slightly depending on sample quality and laboratory scheduling.
No fasting or physical preparation is needed. However, you must provide a detailed clinical history, which is required for the test to be processed. Bring your original histopathology report and any relevant radiology or pathology records when submitting your sample.
IHC Marker - PDL-1(SP142, VENTANA) Test
