
PD-L1 IHC 22C3 pharmDx for Autostainer Link 48

PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity.
PD-L1 protein expression in HNSCC, cervical cancer, TNBC and gastric or GEJ Jadenocarcinoma is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC, HNSCC, cervical cancer, TNBC and gastric or gastroesophageal junction (GEJ) adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).
PD-L1 IHC 22C3 pharmDx may be used to determine PD-L1 status in melanoma patients being considered for treatment.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with LIBTAYO® (cemiplimab).
Please refer to the full intended use for indications and PD-L1 expression levels.For details on staining interpretation, refer to section 13 of the Instructions for Use.
PD-L1 IHC 22C3 pharmDx
The kit includes reagents required for the immunohistochemical staining (except EnVision FLEX Wash Buffer and Hematoxylin (Link)), control slides representing positive and negative PD-L1 protein expression, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal mouse antibody to PD-L1 and 50 slides incubated with the corresponding negative control reagent, 100 slides in total).
For countries outside of Australia, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy.
For countries outside of Australia, see the local LIBTAYO product label for approved indications.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
LIBTAYO® is a registered trademark of Regeneron Pharmaceuticals, Inc.