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:
* VENTANA PD-L1 (SP142) Assay may not be available for some indications and/or cutoffs in all geographies.
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 CE-IVD marked 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:
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 CE-IVD marked 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 intended for the immunohistochemical assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor-infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tissues indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a BenchMark IHC/ISH 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 for identifying patients for treatment with the therapies listed in Table 1 for the respective indications and cutoffs in accordance with the approved therapeutic product labeling.
VENTANA PD-L1 (SP142) Assay may be associated with enhanced patient benefit with the therapies listed in Table 2 for the corresponding indication and cutoffs in accordance with the approved therapeutic product labeling.
Table 1. Companion diagnostic indications for the VENTANA PD-L1 (SP142) Assay.
Se hela tabellenTable 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 |
Table 2. VENTANA PD-L1 (SP142) Assay complementary diagnostic indication.
Se hela tabellenTable 2. VENTANA PD-L1 (SP142) Assay complementary diagnostic indication.
Indication for use | Therapy |
Cutoff |
---|---|---|
Non-small Cell Lung Cancer (NSCLC) |
TECENTRIQ | ≥ 50% TC or ≥ 10% IC |
≥ 1% TC or ≥ 1% IC |
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.