IHC Marker - PDL-1(22C3, DAKO) Test
About IHC Marker - PDL-1(22C3, DAKO) Test
| Field | Value |
|---|---|
| Also Known As | PD-L1 22C3 pharmDx, PDL-1 IHC 22C3, PD-L1 Dako 22C3, CD274, B7-H1 |
| Sample Type | FFPE Tissue Block (formalin-fixed, paraffin-embedded tumour tissue) |
| Fasting Required | No fasting required |
| Report Time | 7 days |
| Recommended For | Adults diagnosed with specific cancers being evaluated for immunotherapy eligibility |
| Price | Starting at ₹14,400 |
What is an IHC Marker - PDL-1(22C3, DAKO) Test?
The IHC marker - PDL-1 test is a specialised immunohistochemistry (IHC) assay that detects a protein called PD-L1 (Programmed Death Ligand 1) in tumour tissue. This protein acts as an immune checkpoint, and its presence can influence how the immune system responds to cancer cells.
Oncologists use this test to decide whether a patient is eligible for certain immunotherapy treatments. It is also known as the PD-L1 22C3 pharmDx test or the PD-L1 Dako 22C3 test and uses the 22C3 clone with a Dako-validated system.
What Does an IHC Marker - PDL-1(22C3, DAKO) Test Measure?
The IHC marker - PDL-1(22C3, DAKO) test examines tumour tissue for the presence and level of PD-L1 protein expression. Results are reported using two main scoring systems, depending on the cancer type involved.
| Parameter | What It Measures |
|---|---|
| PD-L1 Protein Expression | Whether PD-L1 protein is present on cancer and immune cells in the tumour sample |
| Tumour Proportion Score (TPS) | The percentage of viable tumour cells showing PD-L1 membrane staining |
| Combined Positive Score (CPS) | PD-L1-staining cells (tumour cells, lymphocytes, and macrophages) divided by total viable tumour cells, multiplied by 100 |
Why is an IHC Marker - PDL-1(22C3, DAKO) Test Done?
This test is ordered as part of cancer treatment planning, particularly when immunotherapy is being considered. A doctor will request it based on the patient's diagnosis and the stage of disease.
Common Symptoms That May Require This Test
The following clinical situations commonly lead an oncologist to order this test:
- A confirmed cancer diagnosis in tissues such as lung, stomach, cervix, or head and neck
- Disease progression despite standard chemotherapy
- Planning for first-line or second-line treatment in advanced or metastatic cancer
- Evaluation for eligibility before starting pembrolizumab or cemiplimab therapy
- A new biopsy taken after disease progression to reassess treatment options
- Inadequate tissue from a previous biopsy requiring resampling
Conditions This Test Can Help Detect
The PDL-1 IHC 22C3 assay is used as a predictive biomarker across several cancer types:
- Non-small cell lung cancer (NSCLC)
- Triple-negative breast cancer (TNBC)
- Head and neck squamous cell carcinoma (HNSCC)
- Gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Cervical carcinoma
- Urothelial carcinoma (bladder cancer)
- Esophageal squamous cell carcinoma (ESCC)
How to Prepare and What to Expect
No special personal preparation is needed for this test. However, the quality of the tissue sample and the information provided with it are critical to obtaining an accurate result.
Do You Need to Fast?
No fasting is required for this test. Because the sample is tumour tissue and not blood or urine, dietary restrictions do not apply.
Practical Tips Before Your Test
Please keep the following in mind before submitting a sample:
- Bring a detailed clinical history, including your symptoms, previous test results, and relevant medical records, as this is required for the test
- Provide the histopathology report from the original biopsy or surgery
- Discuss with your oncologist which biopsy site is most appropriate for submission
- Ensure the tissue is from a site that has not been previously irradiated, where possible
- The tissue block must contain at least 100 viable tumour cells for the test to be performed
Step-by-Step Procedure
The IHC marker - PDL-1 test procedure involves several laboratory steps after the tumour tissue has been collected by a specialist:
- A core needle biopsy, excisional biopsy, or surgical resection is performed by a qualified doctor. Fine needle aspirates are not acceptable for this test.
- The collected tissue is fixed in 10% neutral-buffered formalin and embedded into a paraffin block (FFPE tissue block), which is the sample required for this test.
- Thin sections (4 to 5 microns thick) are cut from the tissue block and mounted onto glass slides.
- Slides are processed using an automated immunohistochemistry system with the 22C3 mouse anti-PD-L1 monoclonal antibody on a Dako-validated platform.
- A trained pathologist examines the stained slides and calculates the TPS or CPS score, depending on the tumour type.
- The tissue block is stored and transported at ambient temperature (18 to 28 degrees Celsius) and dispatched to the Lupin Diagnostics laboratory for analysis.
Factors That Can Affect Accuracy
Several factors may influence the reliability of this test:
- Improper fixation, storage, or processing of the tissue sample before staining
- Prolonged storage of the paraffin block (over 1 to 3 years) may reduce PD-L1 staining intensity
- Long-term storage of unstained tissue sections should be avoided
- Radiation to the biopsy site before sampling may alter results
- Insufficient tumour cell content in the submitted sample
- Tumour heterogeneity, where different parts of a tumour may express PD-L1 at different levels
Understanding Your IHC Marker - PDL-1(22C3, DAKO) Test Results
Results from this test are reported as a score rather than a simple positive or negative value. A pathologist interprets the staining pattern to calculate either a TPS or CPS score, which your oncologist will then use to guide treatment decisions.
| Score | Threshold | Interpretation |
|---|---|---|
| TPS (NSCLC) | Less than 1% | PD-L1 expression not detected |
| TPS (NSCLC) | 1% or above | PD-L1 expression present; potential eligibility for certain immunotherapy |
| TPS (NSCLC) | 50% or above | High PD-L1 expression; greater likelihood of response to immunotherapy |
| CPS (Multiple tumour types) | Less than 1 | PD-L1 expression not detected |
| CPS (Multiple tumour types) | 1 or above | PD-L1 expression present |
| CPS (Multiple tumour types) | 10 or above | Higher positive threshold required for some treatment eligibility |
Disclaimer: These ranges are general guidelines. Your doctor will interpret your results based on your age, health history, cancer type, and other factors. Always consult a qualified healthcare professional for personalised medical advice.
Results During Special Conditions
Certain factors specific to cancer biology and sample handling can affect how results are read:
Tumour heterogeneity means that PD-L1 expression may vary across different areas of the same tumour. This can occasionally affect scoring and the decisions made based on it.
Previous radiation to the biopsy site, the age of the tissue block, and how the sample was stored can all reduce staining accuracy. Your pathologist and oncologist will consider these factors when reviewing your report.
How to Maintain Healthy Levels
PD-L1 expression is determined by tumour biology and is not directly influenced by lifestyle choices. However, the following steps support the best possible test outcome:
- Submit fresh, adequately fixed tissue samples as soon as possible after the biopsy
- Follow your oncologist's guidance on timing and site selection for biopsy
- Attend all scheduled follow-up appointments to discuss your results and next steps
Lupin Diagnostics IHC Marker - PDL-1(22C3, DAKO) Test Price
The PD-L1 Dako 22C3 test cost at Lupin Diagnostics starts at ₹14,400. This test requires a visit to a Lupin Diagnostics centre or submission of a prepared FFPE tissue block through your treating hospital.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 14400 |
| CHENNAI | 14400 |
| HYDERABAD | 14400 |
| KOLKATA | 14400 |
| NAVI MUMBAI | 14400 |
| PUNE | 14400 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
The IHC marker - PDL-1 test online booking process is straightforward:
- 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 your treating hospital for submission of the FFPE tissue block
- Receive your report via email or WhatsApp within 7 days
Frequently Asked Questions
The IHC marker - PDL-1(22C3, DAKO) test helps oncologists determine whether a patient's tumour expresses enough PD-L1 protein to potentially benefit from certain immunotherapy drugs. It is used in treatment planning for cancers such as lung, cervical, gastric, and head and neck cancers, among others.
This test requires a formalin-fixed, paraffin-embedded (FFPE) tissue block obtained through a biopsy or surgical procedure. Fine needle aspirates are not acceptable. The block is submitted directly to the laboratory for processing.
TPS, or Tumour Proportion Score, measures the percentage of tumour cells on the slide that show PD-L1 staining. CPS, or Combined Positive Score, also includes staining in surrounding immune cells such as lymphocytes and macrophages. Different cancer types use different scoring methods.
At Lupin Diagnostics, the report is delivered within 7 days. This accounts for sample processing, staining, pathologist review, and report preparation. The time may vary depending on sample quality and laboratory workflow.
Not necessarily. A low or negative PD-L1 result means certain immunotherapy agents may not be recommended as a standalone treatment. However, some patients still benefit from immunotherapy used in combination with chemotherapy. Your oncologist will review all available information before making a treatment recommendation.
In many cases, yes. If the tissue block contains sufficient tumour material, your oncologist may request additional molecular or genetic tests on the same block. Discuss this with your treating doctor to plan all required tests together.
Yes. Different PD-L1 assays use different antibody clones and scoring systems. The 22C3 clone validated on the Dako platform is specifically approved as a companion diagnostic for certain immunotherapy drugs. Results from one assay should not be directly substituted for another without guidance from your oncologist.
IHC Marker - PDL-1(22C3, DAKO) Test
