In the United States, PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC, ESCC, cervical cancer, HNSCC, and TNBC patients for treatment with KEYTRUDA® (pembrolizumab). PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with LIBTAYO® (cemiplimab-rwlc).
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 ESCC, cervical cancer, HNSCC, and TNBC 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.
The kit has all necessary components for 50 tests in one kit. It is designed for use on Autostainer Link 48, which comes preprogrammed with a validated staining protocol in the DakoLink software. For In Vitro Diagnostic Use.