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PD-L1 Lung (Pembrolizumab or Cemiplimab), IHC
Test Code93279
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block submitted in IHC specimen transport kit
Other Acceptable Specimens
Minimum: 5 unstained, positively charged slides submitted in IHC specimen transport kit
Instructions
FFPE: State any other type of fixative used. A pathology report which includes the paraffin block number, and both macroscopic and microscopic evaluation and diagnosis, should be sent with the specimens.
Transport Temperature
Room temperature
Specimen Stability
Tissue block
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Slides
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Slides
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Cytology cell block • Decalcified specimens • Fixatives other than formalin • Baked or melted slides • Previously stained slides • Cytospins • Lung cancer specimens (primary or metastatic) are the only acceptable tissue type, other tissue types submitted will be rejected
Methodology
Immunohistochemical Stain
Setup Schedule
Set up: Mon-Fri; Report available: 3-5 days
Reference Range
See Laboratory Report
Clinical Significance
The PD-L1 pharmaDx qualitative assay is intended for use in the detection of PD-L1 in formalin-fixed, paraffin embedded (FFPE) non-small cell lung carcinoma (NSCLC). PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab).
