PD-L1 SP142 FDA (Tecentriq) for NSCLC

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. 

LAB6417

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
or
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.
For PD-L1 SP142 evaluation, tissue submitted must have ≥50 viable tumor cells present.

Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.

48 hours

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.