PD-L1 Lung (Nivolumab), IHC

Test Code
MDFCPIHC93359 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)


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


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



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.