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PD-L1 Lung (Pembrolizumab or Cemiplimab), IHC
Test Code93279
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin embedded (FFPE) tissue block submitted in IHC specimen transport kit
Minimum Volume
5 slides
Other Acceptable Specimens
5 unstained 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.
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
Paraffin 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
A.M. Sets up 5 days a week.
Report Available
Reports in 3 to 5 days.
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).