VENTANA PD-L1 (SP142) Assay (CE IVD)

Predictive IHC assay

PD-L1 SP142 Assay
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Empowering pathologists to answer PD-L1 questions

VENTANA PD-L1 (SP142) Assay gives you the confidence to appropriately identify urothelial carcinoma (UC) and non-small cell lung cancer (NSCLC) patients most likely to benefit from TECENTRIQ® (atezolizumab).    

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 approved test for TECENTRIQ in 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:

  • Only approved test to predict UC patient response to TECENTRIQ
  • Designed to enhance visual contrast of immune cell staining within the tumour microenvironment
  • Stains PD-L1 in both tumour cells (TC) and tumour-infiltrating immune cells (IC)

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 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 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.

VENTANA PD-L1 (SP142) Assay is intended for the immunohistochemical assessment of the programmed death-ligand 1 (PD-L1) protein in tumour cells and tumour-infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tumour tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark IHC/ISH 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. PD-L1 expression may be associated with improved patient outcomes observed in clinical trials. See the TECENTRIQ® (atezolizumab) product label for the significance of PD-L1 expression levels in specific clinical settings.

PD-L1 expression in IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue may be associated with increased objective response rate (ORR).

PD-L1 expression in TC or IC determined by VENTANA PD-L1 (SP142) Assay in NSCLC tissue may be associated with enhanced overall survival.

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