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25646 PD-L1 22C3, IHC (KEYTRUDA)

PD-L1 22C3, IHC (KEYTRUDA)
Test Code: PDL1SO
Synonyms/Keywords

NOTE: This test is only for internal use only.  It is active in the Lab System only – and will need to be manually entered via LOM if needed.

PD-L1, PDL1, 22C3, KEYTRUDA, pembrolizumab, IHC, Immunohistochemistry

Useful For
PD-L1 IHC 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 using EnVision FLEX visualization system on Autostainer Link 48. Used in KEYNOTE/KEYTRUDA clinical trials for lung cancer with FDA approval.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Tissue ​FFPE tissue block One (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered ​Must have at least 100 tumor cells
Specimen Stability Information
Specimen Type Temperature
​Tissue ​Ship with cold pack
Rejection Criteria
Less than 100 tumor cells
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​NeoGenomics Laboratories ​Monday through Saturday ​2 days ​Immunohistochemistry (IHC)
Reference Lab
Test Information
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab) or LIBTAYO® (cemiplimab-rwlc). Results are considered positive for KEYTRUDA when Tumor Proportion Score (TPS) is ≥1% and for LIBTAYO when TPS is ≥50%.
Reference Range Information
See Report
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
​88360
Synonyms/Keywords

NOTE: This test is only for internal use only.  It is active in the Lab System only – and will need to be manually entered via LOM if needed.

PD-L1, PDL1, 22C3, KEYTRUDA, pembrolizumab, IHC, Immunohistochemistry

Ordering Applications
Ordering Application Description
​Centricity ​PD-L1 22C3, IHC (KEYTRUDA)
​Cerner ​PD-L1 22C3, IHC (KEYTRUDA)
​Clinical Order Manager ​PD-L1 22C3, IHC (KEYTRUDA)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​Tissue ​FFPE tissue block One (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered ​Must have at least 100 tumor cells
Specimen Stability Information
Specimen Type Temperature
​Tissue ​Ship with cold pack
Rejection Criteria
Less than 100 tumor cells
Useful For
PD-L1 IHC 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 using EnVision FLEX visualization system on Autostainer Link 48. Used in KEYNOTE/KEYTRUDA clinical trials for lung cancer with FDA approval.
Reference Range Information
See Report
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​NeoGenomics Laboratories ​Monday through Saturday ​2 days ​Immunohistochemistry (IHC)
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
​88360
For most current information refer to the Marshfield Laboratory online reference manual.