VENTANA PD-L1 (SP263) Assay (FDA Approved)

Predictive IHC assay

PD-L1 SP263 Assay UC stain image
Have any questions?
CONTACT US
Empowering pathologists to answer PD-L1 questions

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying NSCLC patients eligible for treatment with TECENTRIQ®.

Non-small cell lung cancer (NSCLC)

VENTANA PD-L1 (SP263) Assay expands immunotherapy options for NSCLC patients through equipping pathologists by:

  • Identifying NSCLC patients eligible for treatment with TECENTRIQ (atezolizumab)
  • Allowing optimal lung tissue management through PD-L1 testing of archived unstained slides within 12 months

VENTANA PD-L1 (SP263) Assay is a qualitative immunohistochemistry assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the programmed death ligand-1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue specimens by light microscopy. The VENTANA PD-L1 (SP263) Assay is used with the OptiView DAB IHC Detection Kit for staining on the BenchMark ULTRA instrument.

NSCLC:

PD-L1 protein expression in ≥ 1% TC in NSCLC tissue is indicated as an aid in identifying NSCLC patients for treatment with Tecentriq (atezolizumab). *

 

Table 1. Therapy and associated indication.

View Full Table

Table 1. Therapy and associated indication.

Indication for use Therapy PD-L1 Expression
NSCLC TECENTRIQ® ≥1% TC

*Please refer to the VENTANA PD-L1 (SP263) Assay method sheet for the full intended use statement and approved therapeutic labeling.