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

Predictive IHC assay

VENTANA 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:

  • Select triple–negative breast cancer (TNBC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
  • Select urothelial carcinoma (UC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
  • Select non-small cell lung cancer (NSCLC) patients eligible for treatment with TECENTRIQ® (atezolizumab)
Companion diagnostic approvals

Triple-negative breast cancer, urothelial carcinoma and non-small cell lung cancer

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 triple–negative breast cancer (TNBC), urothelial carcinoma (UC) and non-small cell lung cancer 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 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 BenchMark ULTRA instrument.

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 tumor cells and tumor 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 BenchMark ULTRA 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 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.

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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
Non-Small Cell Lung Cancer (NSCLC) TECENTRIQ ≥ 50% TC or ≥ 10% IC

Depending on therapeutic setting, 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). Refer to the approved therapeutic product labeling for further information.

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.