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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 FDA, CHECKMATE, OPDIVO
Useful For
PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (SCCHN), and urothelial carcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48. 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

​2 days

 Immunohistochemistry (IHC)
Reference Lab
NeoGenomics Laboratories
Test Information

​Testing is not required for use of OPDIVO® in NSCLC, head and neck squamous cell carcinoma, or urothelial carcinoma, but may provide physicians more information and inform patient dialogue. In non-squamous NSCLC, PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx may be associated with enhanced survival from OPDIVO®.

Reference Range Information
See Report
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​88360 ​ ​ ​ ​
Synonyms/Keywords
PD-L1, PDL1, 28-8 FDA, CHECKMATE, OPDIVO
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
PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (SCCHN), and urothelial carcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48. FDA approved for lung cancer (CHECKMATE 057 Clinical Trial).
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
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.