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PD-L1 LDT
MessageProgrammed cell death ligand 1 (PD-L1) is a transmembrane protein involved in cellular and humoral immune response regulation. PD-L1 expression has been found in a variety of cancers expressed on tumor and/or immune cells. This lab developed test uses the Zeta PD-L1 monoclonal antibody clone ZR3 to detect PD-L1 in formalin-fixed paraffin-embedded tissues.
Test Code
LAB6402
CPT Codes
88360x1
Preferred Specimen
A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
or
One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
For PD-L1 LDT evaluation, tissue submitted must have ≥100 viable tumor cells present.
or
One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
For PD-L1 LDT evaluation, tissue submitted must have ≥100 viable tumor cells present.
Instructions
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
Methodology
IHC
Report Available
48 hours
Clinical Significance
The utility of PD-L1 (ZR3) in predicting the response to anti-PD-1/PD-L1 has not been determined and no standardized scoring criteria currently exist. For therapies and indications that have an FDA-approved PD-L1 companion diagnostic, it is recommended to use the associated FDA approved PD-L1 test.
Performing Laboratory
Neogenomics Laboratories
