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25648 PD-L1 28-8 FDA (OPDIVO/Nivolumab)

PD-L1 28-8 FDA (OPDIVO/Nivolumab)   
Test Code: MISCTIS
Synonyms/Keywords
PD-L1, PDL1, 28-8, CHECKMATE, OPDIVO
Test Components
PD-L1 Immunohistochemistry (IHC) 28-8 pharmDx Kit. Epitomics rabbit monoclonal antibody incorporating a Dako IHC EnVision FLEX visualization system.
Useful For
Qualitative/semi-quantitative measurement of PDL1 on tumor cells of melanoma, lung cancer, head, and neck cancers. FDA approved for lung cancer (CHECKMATE 057 Clinical Trial).
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 atleast 100 tumor cells ​
Collection Processing Instructions
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
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

Turnaround time (Analytical time + 2 days): 4 days
TAT for late pending functionality ONLY
​Immunohistochemistry (IHC)/Autostainer Link 48
Reference Lab
NeoGenomics Laboratories
Reference Range Information
See Report
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​88360 ​ ​ ​ ​
Synonyms/Keywords
PD-L1, PDL1, 28-8, CHECKMATE, OPDIVO
Test Components
PD-L1 Immunohistochemistry (IHC) 28-8 pharmDx Kit. Epitomics rabbit monoclonal antibody incorporating a Dako IHC EnVision FLEX visualization system.
Ordering Applications
Ordering Application Description
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 atleast 100 tumor cells ​
Collection Processing
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
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 melanoma, lung cancer, head, and neck cancers. FDA approved for lung cancer (CHECKMATE 057 Clinical Trial).
Test Components
PD-L1 Immunohistochemistry (IHC) 28-8 pharmDx Kit. Epitomics rabbit monoclonal antibody incorporating 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

Turnaround time (Analytical time + 2 days): 4 days
TAT for late pending functionality ONLY
​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.