What is OmniSeq PD-L1 testing?
PD-L1 D-IC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1,Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin embedded (FFPE) non-small cell lung cancer (NSCLC) tissue.
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with Pembrolizumab (KEYTRUDA®).
This assay identifies a Tumor Proportion Score (TPS) based on the presence of a PD-L1 signal on tumor cells. Identifying PD-L1 expression on tumor cells is important to assess whether patients will respond to anti-PD-1 therapy.
The TPS falls into 1 of 3 categories which will determine whether or not a patient expresses an adequate PD-L1 signal to pursue therapy. These categories are:
- TPS ≥ 50% (High PD-L1 expression)
- TPC 1-49% (PD-L1 expression)
- TPS < 1% (No PD-L1 expression)