The VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue on a VENTANA BenchMark ULTRA instrument. Evaluation is based on the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity. Primary or metastatic urothelial carcinoma (bladder cancer) Primary or metastatic NSCLC tissues may be submitted. For non-small cell lung cancer, please order PD-L1 SP142 FDA (TECENTRIQ®) for NSCLC. For triple-negative breast cancer, please order PD-L1 SP142 FDA (TECENTRIQ®) for TNBC (Breast).
Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.
PD-L1 expression in ≥5% tumor-infiltrating immune cells as determined by this assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) to TECENTRIQ® (atezolizumab) in a non-randomized study. This test is a companion diagnostic for use of Tecentriq in certain urothelial carcinoma cases.
- A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
- One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered
- Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
Global: 48 hours, Tech-Only (stain only): 24 hours
TECENTRIQ® [package insert]. South San Francisco, CA: Genentech, Inc.; Revised 7/2018