VENTANA PD-L1 (SP142) Assay

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)
  • 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 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 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 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 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 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 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 VENTANA 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

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.