To view associated reagents, ancillaries and bulks, please visit the Roche Tissue Diagnostics reagent catalog.
Predictive IHC assay
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 tumour 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 tumour cell (TC) and tumour-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 tumour cells and tumour 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 tumour area occupied by PD-L1 expressing tumour-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumour 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 TableTable 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.