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

Guiding immunotherapy decisions

VENTANA PD-L1 (SP263) Assay identifies patients who are most likely to respond to specific therapy, so that you can make informed, efficient treatment decisions that can lead to better clinical outcomes and improved quality of life. We support your expertise by providing you with the tools that you need to successfully implement these assays into your laboratory and interpret them proficiently.

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Empowering pathologists to answer PD-L1 questions

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:

Non-small cell carcinoma (NSCLC) patients eligible for treatment with TECENTRIQ^® (atezolizumab)
NSCLC patients eligible for treatment with LIBTAYO^® (cemiplimab)

VENTANA PD-L1 (SP263) Assay further benefits patients by:

Providing robust PD-L1 staining in both tumor cells (TC) and tumor-infiltrating immune cells (IC)^†
Allowing optimal lung tissue management through PD-L1 testing of archived unstained slides within 12 months

Reagent and ancillary product information

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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 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with TECENTRIQ^® (atezolizumab).

PD-L1 expression in tumor cell (TC) membrane as detected by VENTANA PD-L1 (SP263) Assay in NSCLC is indicated as an aid in identifying patients for treatment with LIBTAYO^® (cemiplimab).

Table 1. Therapy and associated indication.

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Indication for use	Therapy	PD-L1 Expression
NSCLC	TECENTRIQ^®	≥1 % TC
NSCLC	LIBTAYO^®	≥50 % TC

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

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^†IC staining with this assay is not used to assess PD-L1 status in NSCLC.

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

Guiding immunotherapy decisions

VENTANA PD-L1 (SP263) Assay guides immunotherapy decisions by identifying:

VENTANA PD-L1 (SP263) Assay further benefits patients by:

Related information

Reagent and ancillary product information

Table 1. Therapy and associated indication.

Table 1. Therapy and associated indication.

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