Foundation Medicine offers two antibodies to test for PD-L1 expression:
Scoring and clone utilization for PD-L1 testing is based on FDA-approved indications. Please download the list of “IHC PD-L1 FDA-Approved Companion Diagnostics” for more information.
PD-L1 Dako 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) tissue from multiple tumor types in accordance with the approved product labeling.
PD-L1 Ventana SP142 is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissue in accordance with the approved product labeling.
For breast cancer cases PD-L1 testing will be performed using the Ventana SP142 assay unless otherwise requested.
For tumors with no CDx indication, Foundation Medicine will perform PD-L1 testing using the Dako PD-L1 22C3 PharmDx assay.
For Urothelial Carcinoma (URC), if PD-L1 testing with the Ventana SP142 clone is preferred, please indicate that preference on the test requisition form, via online ordering, or contact our client services team at +1 888.988.3639 or by email at email@example.com.