VENTANA PD-L1 (SP142) Assay

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DIAGNOSTICS F. Hoffmann-La Roche Ltd

VENTANA PD-L1 (SP142) Assay

Positive UC tissue stained with PD-L1 (SP142) assay, 10x
Catalog Number:740-4859
Ordering Code:07709374001
Quantity:50 tests
Clone Name:SP142
Localization:Membranous and/or Cytoplasmic Staining
Regulatory Status:IVD

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.

Indication for useTherapyCutoff
Urothelial CarcinomaTECENTRIQ≥ 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).

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.

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