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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

Test Components
PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx Kit using a mouse monoclonal Anti-PD-L1 and a Dako IHC EnVision FLEX visualization system.
Useful For
Qualitative/semi-quantitative measurement of PDL1 on tumor cells of non-small cell lung cancer (NSCLC) tissues. 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 ​48 hours ​Immunohistochemistry (IHC)/Autostainer Link 48
Reference Lab
NeoGenomics Laboratories
Test Information
​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. PD-L1 IHC 22C3 pharmDx is indicated as an aid identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab).
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

Test Components
PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx Kit using a mouse monoclonal Anti-PD-L1 and a Dako IHC EnVision FLEX visualization system.
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
Qualitative/semi-quantitative measurement of PDL1 on tumor cells of non-small cell lung cancer (NSCLC) tissues. Used in KEYNOTE/KEYTRUDA clinical trials for lung cancer with FDA approval.
Test Components
PD-L1 Immunohistochemistry (IHC) 22C3 pharmDx Kit using a mouse monoclonal Anti-PD-L1 and a Dako IHC EnVision FLEX visualization system.
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 ​48 hours ​Immunohistochemistry (IHC)/Autostainer Link 48
Reference Lab
NeoGenomics Laboratories
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.