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PDL-1 (SP263) by IHC - Ventana, FFPE Tissue
Immunity
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Immunohistochemistry marker.
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PDL-1 (SP263) by IHC - Ventana FFPE Tissue
- Why is it done?
- Detects programmed death ligand-1 (PD-L1) expression in tumor cells using immunohistochemistry on formalin-fixed, paraffin-embedded (FFPE) tissue samples
- Predicts response to PD-L1 and PD-1 checkpoint inhibitor immunotherapies, particularly in non-small cell lung cancer (NSCLC), melanoma, urothelial carcinoma, head and neck squamous cell carcinoma, and other malignancies
- Used for treatment stratification and selection of patients who may benefit from immunotherapy with checkpoint inhibitors
- Typically performed on archival or newly obtained tumor tissue samples at initial diagnosis or at progression
- Aids oncologists in determining eligibility for immunotherapy-based treatment regimens and predicting clinical outcomes
- Normal Range
- Result is reported as PD-L1 tumor proportion score (TPS) expressed as a percentage (%)
- Negative/Low: <1% PD-L1 expression in tumor cells indicates minimal PD-L1 expression; typically considered PD-L1 negative
- Low-Intermediate: 1-49% PD-L1 expression suggests modest PD-L1 positivity; clinical significance varies by cancer type and specific cutoff thresholds
- High: ≥50% PD-L1 expression indicates substantial PD-L1 positivity; most significant for predicting response to checkpoint inhibitors
- Borderline: Results between 1-50% require careful clinical interpretation as they may indicate intermediate likelihood of immunotherapy benefit
- Interpretation varies by cancer type and clinical context; different therapeutic cutoffs are established for specific malignancies and drug combinations
- Interpretation
- PD-L1 Negative (<1% TPS): Suggests low likelihood of response to single-agent PD-L1/PD-1 inhibitors alone; may still benefit from combination immunotherapy or alternative treatment approaches
- PD-L1 Positive (≥1% TPS, especially ≥50%): Indicates higher probability of clinical response to checkpoint inhibitor immunotherapy; associated with improved overall survival and progression-free survival in responder populations
- High PD-L1 Expression (≥50%): Generally predictive of improved response rates to first-line checkpoint inhibitor monotherapy in many cancer types; strong indicator for immunotherapy-first treatment approaches
- Intermediate PD-L1 Expression (1-49%): Complex interpretation; may benefit from immunotherapy combined with chemotherapy or targeted agents depending on cancer type and molecular profile
- Factors affecting interpretation: tumor type and histology, tumor microenvironment composition, presence of other biomarkers (microsatellite instability, tumor mutational burden, mismatch repair status), prior treatment history, and disease stage
- SP263 clone characteristics: Ventana SP263 is the tumor proportion score assay showing reasonable concordance with other PD-L1 antibodies; provides automated, standardized scoring methodology
- Clinical significance: PD-L1 status is one of several biomarkers; negative results do not exclude potential immunotherapy benefit as PD-L1-negative tumors may still respond through alternative mechanisms
- Associated Organs
- Primary organ systems: Respiratory system (non-small cell lung cancer, small cell lung cancer), integumentary system (melanoma), urinary system (urothelial carcinoma), upper respiratory tract (head and neck squamous cell carcinoma), and gastrointestinal system (gastric cancer, esophageal cancer)
- Malignancies commonly tested: Non-small cell lung cancer (NSCLC) - primary indication; melanoma (cutaneous and mucosal); urothelial (bladder) carcinoma; head and neck squamous cell carcinoma; renal cell carcinoma; gastric adenocarcinoma; esophageal carcinoma; ovarian cancer; and others
- Lymphoid system involvement: Tumor-infiltrating lymphocytes and immune cell populations in the microenvironment express PD-1 receptors that bind to PD-L1 on tumor cells
- Diseases diagnosed or monitored: Advanced and metastatic malignancies, recurrent tumors, treatment-refractory cancers, and newly diagnosed cancers eligible for immunotherapy
- Associated complications: Progressive disease with checkpoint inhibitors (despite high PD-L1 expression), immune-related adverse events, potential for acquired resistance and loss of PD-L1 expression with prior immunotherapy, and treatment toxicities
- Risk associations: High PD-L1 expression correlates with higher tumor mutational burden and may indicate more aggressive or inflamed tumor phenotypes
- Follow-up Tests
- Complementary molecular testing: Microsatellite instability (MSI) or mismatch repair (MMR) status; tumor mutational burden (TMB) analysis; nextgen sequencing for additional predictive mutations; EGFR, ALK, ROS1 mutation testing in lung cancer
- Additional immunohistochemistry: PD-L2 expression; tumor infiltrating lymphocyte (TIL) assessment; CD8+ T cell quantification; other immune checkpoint markers as clinically indicated
- Imaging studies: Baseline computed tomography (CT) or positron emission tomography (PET) imaging before starting immunotherapy; repeat imaging at 8-12 weeks and subsequent intervals to assess treatment response
- Serial laboratory monitoring: Complete blood count, comprehensive metabolic panel, lactate dehydrogenase (LDH) levels, tumor markers, and inflammatory markers during immunotherapy course
- Repeat PD-L1 testing: May be considered at disease progression, particularly if prior testing was negative or indeterminate; allows assessment of dynamic changes in PD-L1 expression
- Biomarker reassessment: If initial immunotherapy fails, consider re-testing for emerging mutations, secondary malignancies, or clonal evolution; liquid biopsy (circulating tumor DNA) may provide additional prognostic information
- Monitoring frequency: Baseline testing before treatment initiation; response assessment every 8-12 weeks during active immunotherapy; follow-up at disease progression or per clinical protocol
- Fasting Required?
- No - Fasting is not required for this test. PD-L1 IHC testing is performed on archived or newly obtained tissue specimens (not blood samples), therefore fasting status does not apply.
- Tissue specimen preparation: Specimens must be properly fixed in formalin and embedded in paraffin according to standard pathology protocols; improper fixation may compromise test quality
- Specimen requirements: Adequate tumor tissue sampling with sufficient cellularity (minimum 100 viable tumor cells recommended); adequate representation of tumor area
- No medication restrictions: Patients may take all regular medications without interruption; no special dietary modifications needed
- Pre-analytical considerations: Ensure tissue samples are properly labeled with patient identifiers; document date and site of biopsy/resection; maintain proper chain of custody; avoid contamination or degradation of specimens
- Special handling: If using archival paraffin blocks, ensure adequate tissue section thickness (typically 4-5 micrometers); freshly cut sections recommended for optimal antigen preservation
How our test process works!
