Immunohistochemistry PD-L1 SP263 (Ventana) Test
Short Name: PD-L1 SP263 Ventana
Also known as: PD-L1 IHC SP263, Ventana PD-L1 SP263 Assay, PD-L1 Expression Test, PD-L1 Immunohistochemistry SP263, Programmed Death-Ligand 1 SP263 Test
Immunohistochemistry PD-L1 SP263 (Ventana) Test test available at DNA Labs India for ₹7,000. Uses Immunohistochemistry (IHC), Ventana BenchMark Platform, SP263 Antibody Clone on Tumor tissue in 10% Formal-saline OR Formalin Fixed Paraffin Embedded (FFPE) block samples. Results in Report available in 5–7 business days from receipt of adequate tissue specimen. Block specimens: approximately 5 days. Tissue biopsy: approximately 5 days. Large or complex tissue: approximately 7 days.. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr Pasupathy Arumugam
Consultant Pathologist · Reg: 21521
Last reviewed: September 7, 2026
Overview
The purpose of the Immunohistochemistry PD-L1 SP263 (Ventana) test is to detect and semi-quantify the expression of PD-L1 protein in tumor tissue. PD-L1 expression is used to guide immunotherapy decisions in cancers such as Non-Small Cell Lung Cancer (NSCLC) and Urothelial Carcinoma. The test helps oncologists determine patient eligibility for immune checkpoint inhibitor therapy and predict the likelihood of treatment response.
- Test Code
- 1044
- Price
- ₹7,000
- Sample Type
- Tumor tissue in 10% Formal-saline OR Formalin Fixed Paraffin Embedded (FFPE) block
- Result Time
- Report available in 5–7 business days from receipt of adequate tissue specimen. Block specimens: approximately 5 days. Tissue biopsy: approximately 5 days. Large or complex tissue: approximately 7 days.
- Fasting Required
- No
- Method
- Immunohistochemistry (IHC), Ventana BenchMark Platform, SP263 Antibody Clone
Sample Collection
Provide a copy of the Histopathology report, site of biopsy, and clinical history to the laboratory. Ensure the tissue has been properly fixed in 10% neutral buffered formalin and processed into a paraffin block. No specific patient preparation is required as the test is performed on an already collected tissue specimen.
Method: Biopsy or Surgical Resection (performed by treating physician)
Laboratory Analysis
The tissue sample is obtained via biopsy or surgical resection by the treating physician or surgeon. The specimen is then placed in 10% formal-saline for fixation or provided as a pre-prepared FFPE block. This collection step is not performed at the DNA Labs India facility.
Report Delivery
The FFPE tissue block or tissue in formal-saline is shipped to the laboratory at room temperature. The tissue is processed, sectioned, and stained using the Ventana BenchMark platform with the SP263 antibody clone. Results are reviewed and interpreted by a qualified pathologist.
Timeline: Report available in 5–7 business days from receipt of adequate tissue specimen. Block specimens: approximately 5 days. Tissue biopsy: approximately 5 days. Large or complex tissue: approximately 7 days.
Patient Instructions
About This Test
Who Should Get This Test
The purpose of the Immunohistochemistry PD-L1 SP263 (Ventana) test is to detect and semi-quantify the expression of PD-L1 protein in tumor tissue. PD-L1 expression is used to guide immunotherapy decisions in cancers such as Non-Small Cell Lung Cancer (NSCLC) and Urothelial Carcinoma. The test helps oncologists determine patient eligibility for immune checkpoint inhibitor therapy and predict the likelihood of treatment response.
How to Prepare
- Submit tumor tissue in 10% Formal-saline OR Formalin Fixed Paraffin Embedded (FFPE) block
- Ship the specimen at room temperature
- Provide a copy of the Histopathology report along with the sample
- Include the site of biopsy and detailed clinical history
- Ensure adequate viable tumor content in the submitted specimen
- Label the specimen container with patient details and test requested
Doctor's Notes
Reviewed by Dr Pasupathy Arumugam — MBBS, MD (Pathology) · Reg. No. 21521
"PD-L1 testing with the SP263 assay is an essential step in the treatment pathway for patients with advanced Non-Small Cell Lung Cancer (NSCLC) and Urothelial Carcinoma. The Tumor Proportion Score (TPS) helps me determine whether a patient is likely to benefit from immune checkpoint inhibitor therapy. I recommend this test for all eligible patients before initiating systemic therapy, as PD-L1 expression status directly impacts treatment selection and patient outcomes. A TPS of 50% or higher generally indicates a higher likelihood of response to first-line immunotherapy in NSCLC."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Tissue specimen without adequate viable tumor cells for evaluation
- Specimen not fixed according to standard protocol (improper fixation or prolonged ischemia)
- Completely necrotic or autolyzed tissue with no assessable tumor
- Missing histopathology report, biopsy site, or clinical history
- Specimen container improperly labeled or unlabeled
- Severely calcified bone tissue that has not been properly decalcified
Understanding Your Results
TPS < 1% (Negative)
Less than 1% of viable tumor cells show PD-L1 membrane staining. In NSCLC, this is generally considered PD-L1 negative. The patient may still be eligible for immunotherapy in combination with chemotherapy depending on clinical guidelines, but monotherapy with certain checkpoint inhibitors may not be recommended as first-line treatment.
TPS 1–49% (Low Expression)
Between 1% and 49% of viable tumor cells show PD-L1 membrane staining. This indicates low PD-L1 expression. Treatment decisions depend on tumor type, stage, and specific drug indication. Combination therapy with immunotherapy and chemotherapy may be considered.
TPS ≥ 50% (High Expression)
50% or more of viable tumor cells show PD-L1 membrane staining. This indicates high PD-L1 expression. In advanced NSCLC, patients with TPS ≥ 50% may be eligible for first-line monotherapy with pembrolizumab or other approved immune checkpoint inhibitors.
Consult your oncologist or treating physician to interpret the PD-L1 SP263 test results in the context of your overall cancer diagnosis, stage, and treatment plan. Do not make treatment decisions based solely on the PD-L1 score. Your doctor will consider this result alongside other biomarker tests, imaging findings, and your general health status to recommend the most appropriate therapy.
Limitations
- ⚠PD-L1 expression is a dynamic biomarker and may change over the course of disease or after prior treatments
- ⚠Tumor heterogeneity may result in sampling variation; PD-L1 expression in one biopsy may not represent the entire tumor
- ⚠A negative PD-L1 result does not definitively exclude the possibility of response to immunotherapy
- ⚠A positive PD-L1 result does not guarantee a response to immune checkpoint inhibitor therapy
- ⚠The SP263 assay cut-offs and scoring systems are validated primarily for NSCLC and urothelial carcinoma; clinical utility in other tumor types may vary
- ⚠Concordance between different PD-L1 antibody clones and platforms, while generally high, is not absolute across all tumor types
Risks & Considerations
- ●No direct patient risks are associated with the PD-L1 SP263 laboratory test itself, as it is performed on an already collected tissue specimen
- ●The risks associated with tissue collection (biopsy or surgery) are related to the original procedure and not to this specific test
- ●False negative or false positive results are possible due to tumor heterogeneity or technical factors, which may impact treatment decisions
Interfering Factors
- ●Inadequate or delayed tissue fixation may affect antigen preservation and staining quality
- ●Excessive fixation time in formalin beyond recommended duration can degrade PD-L1 antigen
- ●Necrotic or heavily inflamed tissue areas may interfere with accurate scoring
- ●Insufficient viable tumor cell content in the submitted specimen
- ●Previous decalcification treatment of bone tissue specimens may affect results
- ●Tissue processing artifacts or crush artifacts may compromise interpretation
Compare With Similar Tests
| Test | Immunohistochemistry PD-L1 SP263 (Ventana) Test | PD-L1 IHC 22C3 (Dako/Agilent) | PD-L1 IHC 28-8 (Dako/Agilent) | PD-L1 IHC SP142 (Ventana) |
|---|---|---|---|---|
| Comparison | Immunohistochemistry PD-L1 SP263 (Ventana) Test |
Frequently Asked Questions
What is the Immunohistochemistry PD-L1 SP263 (Ventana) test?
Why is the PD-L1 SP263 test performed?
What sample is required for the PD-L1 SP263 test?
How long does it take to get the PD-L1 SP263 test results?
What does a positive PD-L1 test result mean?
What does a negative PD-L1 test result mean?
What is the Tumor Proportion Score (TPS)?
What is the cost of the PD-L1 SP263 (Ventana) test in India?
Which cancers are commonly tested using the PD-L1 SP263 assay?
Can the PD-L1 SP263 test predict response to immunotherapy?
Is home sample collection available for the PD-L1 SP263 test?
How is the PD-L1 SP263 test different from other PD-L1 assays?
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