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HelpTest Code PD-L1 28-8 PD-L1 28-8 FDA (OPDIVO/Nivolumab)
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).
Synonyms/Keywords
PD-L1, PDL1, 28-8 FDA, CHECKMATE, OPDIVO
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
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
Performing Laboratory Name
NeoGenomics Laboratories
Referral Laboratory Information
| Address | Telephone | Website Link | Marshfield Lab Account # |
|---|---|---|---|
| NeoGenomics Laboratories 5 Jenner, Suite 100 Irvine, CA 92618 |
866-776-5907 | https://neogenomics.com | 7309 |
Performing Information
| Performing Location | Day(s) Test Performed | Analytical Time | Methodology/Instrumentation |
|---|---|---|---|
| NeoGenomics Laboratories | Monday through Saturday |
2 days |
Immunohistochemistry (IHC) |
CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 88360 |
Outreach CPT Codes
| CPT | Modifier (if needed) |
Quantity | Description | Comments |
|---|---|---|---|---|
| 88360 |