The VENTANA PD-L1 (SP263) assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP263 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. PD-L1 (SP263) is indicated as an aid in identifying NSCLC patients for treatment with TECENTRIQ® (atezolizumab) or LIBTAYO® (cemiplimab-rwlc). Results are considered positive for TECENTRIQ when tumors have PD-L1 expression on ≥ 1% of tumor cells (TC) at any intensity and positive for LIBTAYO when tumors have PD-L1 expression on ≥50% of tumor cells (TC) at any intensity.
Stain-only (tech-only) testing is available to clients who have completed the test kit manufacturer’s online interpretation training.
- 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 SP263 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.
Global: 48 hours, Tech-Only (stain only): 24 hours
- TECENTRIQ® [package insert]. South San Francisco, CA: Genentech, Inc.;