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) triple-negative breast carcinoma (TNBC) 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 TNBC tissues may be submitted.
Paraffin-embedded (FFPE) tissue block
Ambient (preferred) - indefinitely
Refrigerated – N/A
Frozen – N/A
Immunohistochemistry (IHC)
Tissues with ≥1% IC are considered positive
PD-L1 expression in ≥1% tumor-infiltrating immune cells as determined by this assay in triple-negative breast carcinoma may be associated with increased progression-free survival in patients with advanced, locally unresectable or metastatic TNBC treated with TECENTRIQ® (atezolizumab) and chemotherapy. This test is a companion diagnostic for use of Tecentriq in certain TNBC cases.