To view associated reagents, ancillaries and bulks, please visit the Roche Tissue Diagnostics reagent catalog.
Predictive IHC assay
VENTANA PD-L1 predictive assays identify patients who are most likely to respond to specific therapies, generating results you can trust so that you can make timely diagnostic decisions and therapeutic choices. We support your expertise by providing you with the tools that you need to successfully implement these assays into your laboratory and interpret them proficiently.
VENTANA PD-L1 (SP142) Assay gives you the confidence to:
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:
*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:
*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.View Full Table
Table 1. Companion diagnostic indications for the VENTANA PD-L1 (SP142) Assay.
|Indication for use||Therapy
||≥ 5% IC
|Triple–Negative Breast Carcinoma (TNBC)
||≥ 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.