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PD-L1 Lung (Nivolumab), IHC
Test CodeMDFCPIHC93359 or 93359
CPT Codes
88360
Preferred Specimen
Formalin-fixed paraffin-embedded tissue in IHC specimen transport kit
Other Acceptable Specimens
5 unstained charged(+) slides in IHC specimen transport kit
Transport Temperature
Tissue: Room temperature
Slides: Refrigerated (cold packs)
Slides: Refrigerated (cold packs)
Specimen Stability
Formalin-fixed paraffin-embedded tissue:
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Unstained charged(+) slides:
Room temperature: Unacceptable
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Unstained charged(+) slides:
Room temperature: Unacceptable
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Baked or melted slides; previously stained slides; cytospins; tissue types other than lung cancer specimens; cytology cell block; decalcified specimens; fixatives other than formalin; Non Small Cell Lung (NSCLC) cancer specimens (primary or metastatic) are the only acceptable tissue type, other tissue types submitted will be rejected
Methodology
Immunohistochemical Stain
Setup Schedule
Mon-Fri
Report Available
3-5 days from receipt
Reference Range
See Laboratory Report
Clinical Significance
The PD-L1 IHC 28-8pharmaDx qualitative assay is intended for use in the detection of PD-L1 expression in formalin-fixed, paraffin embedded (FFPE) non-squamous non-small cell lung carcinoma (NSCLC). PD-L1 expression in non-squamous NSCLC may be associated with enhanced survival from OPDIVO (nivolumab).
Performing Laboratory
AmeriPath North Texas

