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VENTANA PD-L1 (SP142) Assay (US FDA Approved)

Predictive IHC assay

Guiding immunotherapy decisions

VENTANA PD-L1 predictive assays identify patients who are most likely to respond to specific therapies, generating results you can trust so that you can make timely diagnostic decisions and therapeutic choices. 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 (SP142) Assay gives you the confidence to:

Select triple–negative breast cancer (TNBC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
Select urothelial carcinoma (UC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
Identify non-small cell lung cancer (NSCLC) patients most likely to benefit from TECENTRIQ® (atezolizumab)

Companion diagnostic approvals

Triple–negative breast cancer and urothelial carcinoma

Using the right test to determine PD-L1 status for immunotherapy options is important. VENTANA PD-L1 (SP142) Assay* is the first and only FDA-approved test for TECENTRIQ in both triple–negative breast cancer (TNBC) and urothelial carcinoma (UC) patients. This novel assay is also the first to evaluate patient PD-L1 expression using immune cell staining and scoring within the tumour microenvironment, providing you with information that can guide immunotherapy decisions.

VENTANA PD-L1 (SP142) Assay:

Designed to enhance visual contrast of immune cell staining within the tumour microenvironment
First PD-L1 assay FDA-approved with an immune cell scoring algorithm
First and only PD-L1 assay clinically proven to identify patients eligible for and most likely to benefit from TECENTRIQ

*In the US only available on the VENTANA BenchMark ULTRA instrument.

Complementary diagnostic approvals

Non-small cell lung cancer (NSCLC)

Using the right test to determine PD-L1 status for immunotherapy options is important, and the VENTANA PD-L1 (SP142) Assay is the only FDA-approved test for TECENTRIQ. This innovative assay is the first to evaluate patient PD-L1 expression using both tumour cell (TC) and tumour-infiltrating immune cell (IC) staining. Determining a patient’s PD-L1 expression level can give insight to the overall survival that may be achieved from TECENTRIQ.*

VENTANA PD-L1 (SP142) Assay:

Only FDA-approved test to assess NSCLC patient treatment benefit from TECENTRIQ
Informative for the clinician of a patient’s potential overall survival
Novel scoring algorithm using PD-L1 staining in both TC and IC
Designed to enhance visual contrast of immune cell staining within the tumour microenvironment

*All randomized patients in a NSCLC phase III study observed benefit from TECENTRIQ regardless of PD-L1 status.

Related information

US testing information

Online training for pathologists

The PD-L1 immunologic checkpoint

The tumour microenvironment

About PD-L1: Rewriting the book on immunotherapy

Learn more about Personalised Healthcare (PHC)

TECENTRIQ.com

Reagent catalog

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 programmed death-ligand 1 (PD-L1) protein in tumour cells and tumour infiltrating immune cells in the formalin-fixed, paraffin-embedded (FFPE) tissues indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument.

Determination of PD-L1 status is indication-specific and evaluation is based on either the proportion of tumour area occupied by PD-L1 expressing tumour-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumour cells (% TC) of any intensity.

VENTANA PD-L1 (SP142) Assay is indicated as an aid in identifying patients for treatment with the therapies for the respective cutoffs listed in Table 1 in accordance with the approved therapeutic product labeling.

Table 1. Companion diagnostic indications for the VENTANA PD-L1 (SP142) Assay.

View Full Table

Indication for use	Therapy	Cutoff
Urothelial Carcinoma	TECENTRIQ	≥ 5% IC
Triple–Negative Breast Carcinoma (TNBC)	TECENTRIQ	≥ 1% IC

PD-L1 expression in ≥ 50% TC or ≥ 10% IC determined by VENTANA PD-L1 (SP142) Assay in non-small cell lung cancer (NSCLC) patients may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).

This product is intended for in vitro diagnostic (IVD) use.