VENTANA® PD-L1 (SP142) Assay

US-FDA
IVD For in vitro diagnostic use.
VENTANA PD-L1 SP142 Assay

VENTANA PD-L1 SP142 IHC assay stain image
Identify non-small cell lung cancer (NSCLC) patients eligible for TECENTRIQ®

Your assay choice matters

Using the right test to determine PD-L1 status for immunotherapy options is important, and the VENTANA PD-L1 (SP142) Assay is an FDA-approved test for TECENTRIQ®. This innovative assay is the first to evaluate patient PD-L1 expression using both tumor cell (TC) and tumor-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®.

The VENTANA PD-L1 (SP142) Assay:

  • FDA approved to identify NSCLC patient treatment benefit from TECENTRIQ®
  • Novel scoring algorithm using PD-L1 staining in both TC and IC
  • Designed to enhance visual contrast of immune cell staining within the tumor microenvironment

The PD-L1 (SP142) Assay gives you the confidence to guide immunotherapy decisions in NSCLC.

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

Staining characteristics in non-small cell lung cancer (NSCLC)

General guidance

A patient’s NSCLC tissue stained with the VENTANA PD-L1 (SP142) Assay is evaluated for tumor cells (TC) and/or tumor-infiltrating immune cells (IC) staining. TC are scored as the proportion of viable tumor cells showing PD-L1 membrane staining of any intensity. IC are scored as the proportion of tumor area that is occupied by PD-L1 staining IC of any intensity.

non-small-image

Figure 1: Positive NSCLC tissue stained with VENTANA PD-L1 (SP142) Assay (≥ 50% TC or ≥ 10% IC). IC often show dark brown punctate or linear staining, which is the predominant IC staining pattern observed in the majority of tissues. IC staining is often seen as aggregates either in intratumoral or peritumoral stroma (tumor-stroma interface) or in both locations. TC often exhibit moderate to strong, partial or complete circumferential membrane staining with or without cytoplasmic component. 

Ordering information

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Ordering information

 

Product name Catalog number Ordering code Quantity
VENTANA PD-L1 (SP142) Assay
   Tissue Control: Tonsil
   Species: Rabbit
   Localization: Membranous and/or
   Cytoplasmic
740-4859  07709374001 50 tests
OptiView DAB IHC Detection Kit  760-700  06396500001
250 tests
OptiView Amplification Kit  860-099  06718663001 250 tests
Rabbit Monoclonal Negative Reagent Control Ig 790-4795  06683380001 250 tests

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Overview

Ordering information

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References

  1. TECENTRIQ® Summary of Product Characteristics.
  2. Ventana Medical Systems Inc. VENTANA PD-L1 (SP142) Assay Package Insert.