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 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 FDA-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 tumor microenvironment, providing you with information that can guide immunotherapy decisions.

VENTANA PD-L1 (SP142) Assay:

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

*In the US only available on the VENTANA BenchMark ULTRA instrument.

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 PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma and nonsmall cell lung cancer (NSCLC) tissue 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.

PD-L1 expression in ≥ 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is indicated as an aid in identifying urothelial carcinoma patients for treatment with TECENTRIQ (atezolizumab).

PD-L1 expression in ≥ 50% TC or ≥ 10% IC determined by VENTANA PD-L1 (SP142) Assay in NSCLC tissue may be associated with enhanced overall survival from TECENTRIQ® (atezolizumab). See the TECENTRIQ product label for PD-L1 expression cutoff values guiding therapy in specific clinical circumstances.

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

  • Catalog number

    740-4859

  • Ordering code

    07709374001

  • Quantity

    50 tests

  • Controls

    Tonsil

  • Isotypes

    SP142

  • Clone name

    Rabbit

  • Species

    Membranous and/or Cytoplasmic Staining

  • Regulatory status

    IVD