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:

  • Identify triple–negative breast cancer (TNBC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
  • Identify 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)

* VENTANA PD-L1 (SP142) Assay may not be available for some indications and/or cutoffs in all geographies. In Switzerland TECENTRIQ is approved for non-small cell lung cancer only.

Companion diagnostic indications

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 CE-IVD marked 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 tumor 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 tumor microenvironment
  • First PD-L1 assay CE-IVD marked 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
Complementary diagnostic indications

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 CE-IVD marked 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.*

VENTANA PD-L1 (SP142) Assay:

  • Only CE-IVD marked 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 tumor 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 tumor cells and tumor-infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tissues indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a BenchMark IHC/ISH instrument.

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

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

VENTANA PD-L1 (SP142) Assay may be associated with enhanced patient benefit with the therapies listed in Table 2 for the corresponding indication and cutoffs in accordance with the approved therapeutic product labeling.

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

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

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

Table 2. VENTANA PD-L1 (SP142) Assay complementary diagnostic indication.

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Table 2. VENTANA PD-L1 (SP142) Assay complementary diagnostic indication.

Indication for use Therapy
Cutoff
Non-small Cell Lung Cancer (NSCLC)
TECENTRIQ ≥ 50% TC or ≥ 10% IC    
≥ 1% TC or ≥ 1% IC    

Test results of this product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

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