Roche BenchMark XT/LT Interpretation Guide

Type
Interpretation Guide

This manual is also suitable for

VENTANA PD-L1 (SP142) Assay
Quick Reference Guide for
Triple-Negative Breast Carcinoma (TNBC)
2 VENTANA PD-L1 (SP142) Assay Quick Reference Guide for Triple-Negative Breast Carcinoma (TNBC)
Table 1: Description of VENTANA PD-L1 (SP142) Assay Scoring Algorithm PD-L1 Expression
Absence of any discernible PD-L1 staining
OR
Presence of discernible PD-L1 staining of any intensity in tumor-infiltrating immune cells covering<1% of tumor area occupied by
tumor cells,associated intratumoral, and contiguous peritumoral stroma
< 1% IC
Presence of discernible PD-L1 staining of any intensity in tumor-infiltrating immune cells covering ≥1% of tumor area occupied by
tumor cells,associated intratumoral, and contiguous peritumoral stroma
≥ 1% IC
Tumor Area
VENTANA PD-L1 (SP142) Assay Scoring Algorithm for TNBC
IC Scoring Method: Aggregates
Combine these regions, and estimate their combined area in the total tumor area. IC is ≥ 1%Visually encircle the IC aggregates as closely as possible
Tumor area in a resection sample Tumor area in multiple tumor nodules Tumor area in a biopsy sample Area of necrosis excluded from tumor area
Tumor cells
Intratumoral stroma
Peritumoral stroma
PD-L1 10x PD-L1 10x
H&E 10x
1x1x1x 1x
VENTANA PD-L1 (SP142) Assay Quick Reference Guide for Triple-Negative Breast Carcinoma (TNBC) 3
VENTANA PD-L1 (SP142) Assay Tumor-Infiltrating Immune Cell (IC) Range of Staining
Scoring IC Single-Cell Spread – Use Reference Images Below
Cell density for single-cell spread IC is < 1% Cell density for single-cell spread IC is ≥ 1%
IC Aggregates
IC Single-Cell Spread
PD-L1 10x
PD-L1 10x
IC < 1%
IC ≥ 1%
(all images 10x magnification)
Differentiate TC Staining from IC Staining
Refer to the corresponding VENTANA PD-L1
(SP142) Assay package insert for manufacturer
contact information.
www.ventana.com
© 2020 Ventana Medical Systems, Inc. and Roche
Diagnostics International, Inc. All rights reserved.
VENTANA and the VENTANA logo are trademarks of
Roche. All other trademarks are the property of their
respective owners.
1018232EN Rev C
IC Scoring – Unique Scenarios
Weak linear TC staining
IC staining
Strong linear TC staining
IC staining
Punctate IC
staining
Exclude IC staining in association with
DCIS without invasive component
Differentiate IC from speckling,
particularly observed in biopsies
Differentiate IC from hemosiderin
pigment
Exclude IC staining in necrotic regions
IC
Neutrophils
Neutrophilic
staining
IC staining
Speckling
Hemosiderin
pigment
PD-L1 10x
PD-L1 20x PD-L1 20x
H&E 10x H&E 20x H&E 10xH&E 10x
PD-L1 10x
PD-L1 10x
PD-L1 20x PD-L1 10x
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Roche BenchMark XT/LT Interpretation Guide

Type
Interpretation Guide
This manual is also suitable for

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