PD‑L1 Lung (Pembrolizumab or Cemiplimab), IHC
Also known as: PDL1, PD-L1 IHC 22C3 pharmDx, Keytruda, PD-L1 IHC 22C3 pharmDx™, PDL-1
Use
The PD‑L1 pharmaDx qualitative assay is intended for the detection of PD‑L1 in formalin‑fixed, paraffin‑embedded (FFPE) non‑small cell lung carcinoma (NSCLC). It is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab).
Special Instructions
Not provided.
Limitations
Not provided.
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
3-5 days
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 block submitted in IHC specimen transport kit; Minimum: 5 unstained, positively charged slides submitted in IHC specimen transport kit; State any other type of fixative used; Include pathology report with paraffin block number and both macroscopic and microscopic evaluation and diagnosis
Causes for Rejection
Cytology cell block; Decalcified specimens; Fixatives other than formalin; Baked or melted slides; Previously stained slides; Cytospins; Tissue types other than lung cancer (primary or metastatic)
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Tissue block: 5 years; Slides: 30 days |
| Refrigerated | Tissue block: 5 years; Slides: 30 days |
| Frozen | Unacceptable |