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PD-L1 Non-Lung (Pembrolizumab), IHC
Test CodeMDFCPNLPDL1 or 36260
Alias/See Also
Keytruda,Dako test PD-L1 IHC 22C3pharmDx™,PDL1,PDL-1
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin-embedded (FFPE) tissue collected in IHC specimen transport kit
Minimum Volume
5 slides
Other Acceptable Specimens
5 (5 micron) unstained charged(+) slides collected in IHC specimen transport kit
Instructions
Tumor primary is not one of the specific types available for this FDA approved test.
Formalin-fixed, paraffin-embedded: 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 specimen.
Formalin-fixed, paraffin-embedded: 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 specimen.
Transport Container
IHC specimen transport kit
Transport Temperature
Room temperature
Specimen Stability
FFPE
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?)
Baked or melted slides • Previously stained slides • Cytospins • Cytology cell block • Decalcified specimens
Methodology
Immunohistochemical Stain
Setup Schedule
Mon-Fri
Report Available
3-5 days
Reference Range
See Laboratory Report
Clinical Significance
PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying patients for treatment with KEYTRUDA® (Pembrolizumab). This FDA approved test currently is applicable only to specific tumor types.
For non-FDA approved test indications or sample types, order 94007-PD-L1, IHC with Interpretation.
For other FDA approved primary tumors, please order the following: For NSCLC order 93279-PD-L1 Lung (Pembrolizumab), IHC, 93359-PD-L1 Lung (Nivolumab), IHC or 94480-PD-L1 Lung (Atezolizumab), IHC; for urothelial bladder carcinoma order 94047-PD-L1 Bladder (Atezolizumab),IHC
For non-FDA approved test indications or sample types, order 94007-PD-L1, IHC with Interpretation.
For other FDA approved primary tumors, please order the following: For NSCLC order 93279-PD-L1 Lung (Pembrolizumab), IHC, 93359-PD-L1 Lung (Nivolumab), IHC or 94480-PD-L1 Lung (Atezolizumab), IHC; for urothelial bladder carcinoma order 94047-PD-L1 Bladder (Atezolizumab),IHC
Performing Laboratory
Ameripath, Texas
