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PD-L1 Non-Lung (Pembrolizumab), IHC
Test Code36260
CPT Codes
88360
Preferred Specimen
Formalin-fixed paraffin embedded tissue block submitted in an IHC specimen transport kit
Other Acceptable Specimens
5 (5-micron sections) unstained, positively charged slides
Instructions
Tumor primary is not one of the specific types available for this FDA approved test.
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 specimen.
Additional Information:
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.
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 specimen.
Additional Information:
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.
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?)
Baked or melted slides • Previously stained slides • Cytospins • Cytology cell block • Decalcified specimens
Methodology
Immunohistochemical Stain
Setup Schedule
Set up: Sun-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
Quest Diagnostics Nichols Institute Chantilly
14225 Newbrook Dr
Chantilly, VA 20153