PD-L1 28-8 pharmDx by Immunohistochemistry with Interpretation, nivolumab (OPDIVO)
Also known as: 28-8 IP
Use
This FDA-approved companion diagnostic test helps predict overall survival benefits for patients treated with nivolumab (OPDIVO) and ipilimumab (YERVOY) as a first-line therapy in non-small cell lung carcinoma. It also aids in predicting responses to nivolumab treatment for patients with nonsquamous non-small cell lung cancer (NSCLC), urothelial carcinoma, or head and neck squamous cell carcinoma (HNSCC).
Special Instructions
Not provided.
Limitations
Testing for PD-L1 expression is not required for certain treatment settings, such as second-line treatment in non-squamous non-small cell lung cancer or treatment for squamous cell carcinoma of the head and neck. There is no established predictive value for PD-L1 expression in tumors outside of NSCLC, SCCHN, and UC. Specimens must have at least 100 viable tumor cells for evaluation. The use of this assay on decalcified tissues or those fixed in media other than 10 percent neutral buffered formalin is not validated.
FDA ApprovedNew York Approved
Methodology
Immunoassay (IHC)
Biomarkers
PD-L1
Protein
LOINC Codes
- 55229-9 - Immune stain study
- 94736-6 - Tissue block ID Spec
- 31208-2 - Specimen source
- 83056-2 - PD-L1 by 28-8 Tiss ImStn-Imp
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
3 slides
Container
Transport tissue block or 5 unstained slides
Collection Instructions
Formalin fix and paraffin embed specimens; protect blocks and/or slides from excessive heat.
Storage Instructions
Room temperature; Refrigerated protection recommended during summer months.
Causes for Rejection
Fewer than 100 viable tumor cells; non-formalin-fixed or decalcified specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |
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