PD‑L1 Lung (Nivolumab), IHC
Also known as: 28-8 (Dako), PD-L1 IHC 28-8 pharmDx, PDL-1
Use
The PD‑L1 IHC 28‑8 pharmDx qualitative assay is intended for use in the detection of PD‑L1 expression in formalin‑fixed, paraffin embedded (FFPE) non‑squamous non‑small cell lung carcinoma (NSCLC). PD‑L1 expression in non‑squamous NSCLC may be associated with enhanced survival from OPDIVO (nivolumab).
Special Instructions
Not provided.
Limitations
Not provided.
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
IHC specimen transport kit
Collection Instructions
Formalin‑fixed, paraffin embedded tissue in IHC specimen transport kit; unstained charged(+) slides in IHC specimen transport kit
Causes for Rejection
Baked or melted slides • Previously stained slides • Cytospins • Tissue types other than lung cancer specimens • Cytology cell block • Decalcified specimens • Fixatives other than formalin
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 5 years (FFPE tissue) |
| Refrigerated | 5 years (FFPE tissue); 30 days (unstained charged slides) |
| Frozen | Unacceptable |