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) non-small cell lung cancer (NSCLC) tissue on a VENTANA BenchMark ULTRA instrument. Evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity. Primary or metastatic NSCLC tissues may be submitted. For bladder cancer, please order PD-L1 SP142 FDA (TECENTRIQ®) for Urothelial Carcinoma. 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 ≥50% tumor cells or ≥ 10% tumor infiltrating immune cells as determined by this assay in NSCLC tissue may be associated with enhanced overall survival from TECENTRIQ (atezolizumab). This test is a complementary diagnostic for use of Tecentriq in certain NSCLC 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